NDC 70518-3103 Gabapentin

Gabapentin

NDC Product Code 70518-3103

NDC CODE: 70518-3103

Proprietary Name: Gabapentin What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Gabapentin What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Gabapentin is used with other medications to prevent and control seizures. It is also used to relieve nerve pain following shingles (a painful rash due to herpes zoster infection) in adults. Gabapentin is known as an anticonvulsant or antiepileptic drug.

Product Characteristics

Color(s):
WHITE (C48325)
Shape: CAPSULE (C48336)
Size(s):
16 MM
Imprint(s):
103
Score: 1

NDC Code Structure

  • 70518 - Remedyrepack Inc.

NDC 70518-3103-0

Package Description: 30 CAPSULE in 1 BLISTER PACK

NDC Product Information

Gabapentin with NDC 70518-3103 is a a human prescription drug product labeled by Remedyrepack Inc.. The generic name of Gabapentin is gabapentin. The product's dosage form is capsule and is administered via oral form.

Labeler Name: Remedyrepack Inc.

Dosage Form: Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Gabapentin Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • GABAPENTIN 100 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • TALC (UNII: 7SEV7J4R1U)
  • GELATIN (UNII: 2G86QN327L)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SHELLAC (UNII: 46N107B71O)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Anti-epileptic Agent - [EPC] (Established Pharmacologic Class)
  • Decreased Central Nervous System Disorganized Electrical Activity - [PE] (Physiologic Effect)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Remedyrepack Inc.
Labeler Code: 70518
FDA Application Number: ANDA090007 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 05-26-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Gabapentin Product Label Images

Gabapentin Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Spl Medguide

Gabapentin (gab'' a pen' tin)CapsulesWhat is the most important information I should know about gabapentin capsules?Do not stop taking gabapentin capsules without first talking to your healthcare provider.Stopping gabapentin capsules suddenly can cause serious problems.Gabapentin capsules can cause serious side effects including:1. Suicidal Thoughts. Like other antiepileptic drugs, gabapentin capsules may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:· thoughts about suicide or dying· attempts to commit suicide· new or worse depression· new or worse anxiety· feeling agitated or restless· panic attacks· trouble sleeping (insomnia)· new or worse irritability· acting aggressive, being angry, or violent· acting on dangerous impulses· an extreme increase in activity and talking (mania)· other unusual changes in behavior or moodHow can I watch for early symptoms of suicidal thoughts and actions?· Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.· Keep all follow-up visits with your healthcare provider as scheduled.Call your healthcare provider between visits as needed, especially if you are worried about symptoms.Do not stop taking gabapentin capsules without first talking to a healthcare provider.· Stopping gabapentin capsules suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).· Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.2. Changes in behavior and thinking -Using gabapentin capsules in children 3 to 12 years of age can cause emotional changes, aggressive behavior, problems with concentration, restlessness, changes in school performance, and hyperactivity.3. Gabapentin capsules may cause a serious or life-threatening allergic reaction that may affect your skin or other parts of your body such as your liver or blood cells. This may cause you to be hospitalized or to stop gabapentin capsule. You may or may not have a rash with an allergic reaction caused by gabapentin capsule. Call a healthcare provider right away if you have any ofThe following symptoms:· skin rash· hives· difficulty breathing· fever· swollen glands that do not go away· swelling of your face, lips, throat or tongue· yellowing of your skin or of the whites of the eyes· unusual bruising or bleeding· severe fatigue or weakness· unexpected muscle pain· frequent infectionsThese symptoms may be the first signs of a serious reaction. A healthcare provider should examine you to decide if you should continue taking gabapentin capsules.What are gabapentin capsules?Gabapentin capsules are a prescription medicine used to treat:· Pain from damaged nerves (postherpetic pain) that follows healing of shingles (a painful rash that comes after a herpes zoster infection) in adults.· Partial seizures when taken together with other medicines in adults and children 3 years of age and older with seizures.Who should not take gabapentin capsules?Do not take gabapentin capsules if you are allergic to gabapentin or any of the other ingredients in gabapentin capsules. See the end of this Medication Guide for a complete list of ingredients in gabapentin capsules.What should I tell my healthcare provider before taking gabapentin capsules?Before taking gabapentin capsules, tell your healthcare provider if you:· have or have had kidney problems or are on hemodialysis· have or have had depression, mood problems, or suicidal thoughts or behavior· have diabetes· are pregnant or plan to become pregnant. It is not known if gabapentin capsules can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking gabapentin capsules. You and your healthcare provider will decide if you should take gabapentin capsules while you are pregnant.o Pregnancy Registry: If you become pregnant while taking gabapentin capsules, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy. You can enroll in this registry by calling 1-888-233-2334.· are breast-feeding or plan to breast-feed. Gabapentin capsules can pass into breast milk. You and your healthcare provider should decide how you will feed your baby while you take gabapentin capsules.Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.Taking gabapentin capsules with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.How should I take gabapentin capsules?· Take gabapentin capsules exactly as prescribed. Your healthcare provider will tell you how much gabapentin capsules to take.o Do not change your dose of gabapentin capsules without talking to your healthcare provider.o Take gabapentin capsules with water.· Gabapentin capsules can be taken with or without food. If you take an antacid containing aluminum and magnesium, such as Maalox®, Mylanta®, Gelusil®, Gaviscon® , or Di-Gel®, you should wait at least 2 hours before taking your next dose of gabapentin capsules.If you take too much gabapentin capsules, call your healthcare provider or your local Poison Control Center right away at 1-800-222-1222.What should I avoid while taking gabapentin capsules?· Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking gabapentin capsules without first talking with your healthcare provider. Taking gabapentin capsules with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.· Do not drive, operate heavy machinery, or do other dangerous activities until you know how gabapentin capsules affects you. Gabapentin capsules can slow your thinking and motor skills.What are the possible side effects of gabapentin capsules?Gabapentin capsules may cause serious side effects including:See “What is the most important information I should know about gabapentin capsules?”· problems driving while using gabapentin capsules. See “What I should avoid while taking gabapentin capsules?”· sleepiness and dizziness which could increase the occurrence of accidental injury, including falls· The most common side effects of gabapentin capsules include:· lack of coordination • feeling tired· viral infection • fever· feeling drowsy • jerky movements· nausea and vomiting • difficulty with coordination· difficulty with speaking • double vision· tremor • unusual eye movement· swelling, usually of legs and feetTell your healthcare provider if you have any side effect that bothers you or that does not go away.These are not all the possible side effects of gabapentin capsules. For more information, ask your healthcare provider or pharmacist.Call your doctor for medical advice about side effects. You may report side effects to Time Cap Laboratories 1 877 290-4008 and/or FDA at 1-800-FDA-1088.How should I store gabapentin capsules?· Store gabapentin capsules between 68°F to 77°F (20°C to 25°C).Keep gabapentin capsules and all medicines out of the reach of children.General information about the safe and effective use of gabapentin capsulesMedicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use gabapentin capsules for a condition for which it was not prescribed. Do not give gabapentin capsules to other people, even if they have the same symptoms that you have. It may harm them.This Medication Guide summarizes the most important information about gabapentin capsules. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about gabapentin capsules that was written for healthcare professionals.What are the ingredients in gabapentin capsules?Active ingredient: gabapentin, USPInactive ingredients in the capsules: lactose monohydrate, corn starch, and talc.The 100 mg capsule shell contains gelatin and titanium dioxide.The 300 mg capsule shell contains gelatin, titanium dioxide, and yellow iron oxide.The 400 mg capsule shell contains gelatin, red iron oxide, titanium dioxide, and yellow iron oxide. The imprinting ink contains FD&C Blue No. 2, propylene glycol and shellac.This Medication Guide has been approved by the U.S. Food and Drug Administration.Rx onlyRepackaged By / Distributed By: RemedyRepack Inc.625 Kolter Drive, Indiana, PA 15701(724) 465-8762

How Supplied

100 mg Capsules (White/White colored, size '3' hard gelatin capsules with "103" printed on body of capsules containing white to off white granular powder)NDC: 70518-3103-00PACKAGING: 30 in 1 BLISTER PACKRepackaged and Distributed By:Remedy Repack, Inc.625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

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