NDC 59556-945 Acid Reducer

Ranitidine Hydrochloride

NDC Product Code 59556-945

NDC CODE: 59556-945

Proprietary Name: Acid Reducer 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: Ranitidine Hydrochloride 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.

Product Characteristics

Color(s):
PINK (C48328)
Shape: ROUND (C48348)
Size(s):
8 MM
Imprint(s):
OR;606
Score: 1

NDC Code Structure

  • 59556 - Strides Pharma Inc

NDC 59556-945-04

Package Description: 1 BOTTLE in 1 CARTON > 30 TABLET, FILM COATED in 1 BOTTLE

NDC Product Information

Acid Reducer with NDC 59556-945 is a a human over the counter drug product labeled by Strides Pharma Inc. The generic name of Acid Reducer is ranitidine hydrochloride. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Strides Pharma Inc

Dosage Form: Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.

Product Type: Human Otc 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.

Acid Reducer 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.

  • RANITIDINE HYDROCHLORIDE 75 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.

  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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.

Product Labeler Information

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

Labeler Name: Strides Pharma Inc
Labeler Code: 59556
FDA Application Number: ANDA201745 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: 12-31-2020 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: 12-31-2021 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Acid Reducer 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

Active Ingredient (In Each Tablet)

Ranitidine 75 mg (as ranitidine hydrochloride USP, 84 mg)

Purpose

Acid reducer

Uses

  • Relieves heartburn associated with acid indigestion and sour stomachprevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages

Warnings

Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers

Do Not Use

  • If you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.with other acid reducers

Ask A Doctor Before Use If You Have

  • Had heartburn over 3 months. This may be a sign of a more serious condition.  heartburn with lightheadedness, sweating or dizziness  chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness  frequent chest pain  frequent wheezing, particularly with heartburn  unexplained weight loss  nausea or vomiting  stomach pain  kidney diseaseAsk a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Stop Use And Ask A Doctor If

  • Your heartburn continues or worsensyou need to take this product for more than 14 days

If Pregnant Or Breast-Feeding

Ask a health professional before use.

Keep Out Of Reach Of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • Adults and children 12 years and over:to relieve symptoms, swallow 1 tablet with a glass of waterto prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburncan be used up to twice daily (do not take more than 2 tablets in 24 hours)children under 12 years: ask a doctor

Other Information

  • TAMPER EVIDENT: DO NOT USE IF THE CARTON OR INDIVIDUAL BLISTER UNIT IS OPEN OR TORN.store at 20° - 25° C (68° - 77° F)avoid excessive heat or humiditythis product is sodium and sugar free

Inactive Ingredients

Colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, talc, titanium dioxide

Questions?

  • Call 1-877-244-9825Tips for managing heartburnDo not lie flat or bend over soon after eatingDo not eat late at night, or just before bedtimeCertain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetablesEat slowly and do not eat big mealsIf you are overweight, lose weightIf you smoke, quit smokingRaise the head of your bedWear loose fitting clothing around your stomachRead the directions and warnings before use. Keep the carton. It contains important information including tips for managing heartburn.Manufactured by: Strides Pharma Science Ltd. Puducherry - 605 014, India. PON/DRUGS/16 13 4193 Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816 Revised: 09/2019

* Please review the disclaimer below.