NDC 43598-883 Lansoprazole

Lansoprazole

NDC Product Code 43598-883

NDC Code: 43598-883

Proprietary Name: Lansoprazole 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: Lansoprazole 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 - OPAQUE PINK COLORED CAP)
GREEN (C48329 - OPAQUE GREEN COLORED BODY)
Shape: CAPSULE (C48336)
Size(s):
3 MM
Imprint(s):
RDY;398
Score: 1

NDC Code Structure

  • 43598 - Dr. Reddy's Laboratories Inc.
    • 43598-883 - Lansoprazole

NDC 43598-883-42

Package Description: 3 BOTTLE in 1 CARTON > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

NDC 43598-883-52

Package Description: 1 BOTTLE in 1 CARTON > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

NDC Product Information

Lansoprazole with NDC 43598-883 is a a human over the counter drug product labeled by Dr. Reddy's Laboratories Inc.. The generic name of Lansoprazole is lansoprazole. The product's dosage form is capsule, delayed release and is administered via oral form.

Labeler Name: Dr. Reddy's Laboratories Inc.

Dosage Form: Capsule, Delayed Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.

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.

Lansoprazole 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.

  • LANSOPRAZOLE 15 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.

  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • GELATIN (UNII: 2G86QN327L)
  • HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)
  • MAGNESIUM CARBONATE (UNII: 0E53J927NA)
  • METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
  • POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • SUCROSE (UNII: C151H8M554)
  • 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: Dr. Reddy's Laboratories Inc.
Labeler Code: 43598
FDA Application Number: ANDA202194 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: 08-01-2019 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: 12-31-2020 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.

Lansoprazole Product Label Images

Lansoprazole 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 Capsule)

Lansoprazole  USP, 15 mg

Purpose

Acid reducer

Use

  • Treats frequent heartburn (occurs 2 or more days a week)not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Warnings

Allergy alert: Do not use if you are allergic to lansoprazole

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.

Ask A Doctor Before Use If You Have

  • Liver diseasehad 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 lightheadednessfrequent chest painfrequent wheezing, particularly with heartburnunexplained weight lossnausea or vomitingstomach pain

Ask 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 daysyou need to take more than 1 course of treatment every 4 monthsyou get diarrheayou develop a rash or joint pain

If Pregnant Or Breast-Feeding,

Ask a healthcare professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

  • Adults 18 years of age and olderthis product is to be used once a day (every 24 hours), every day for 14 daysit may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours14-Day Course of Treatmentswallow 1 capsule with a glass of water before eating in the morningtake every day for 14 daysdo not take more than 1 capsule a daysswallow whole. Do not crush or chew capsules.do not use for more than 14 days unless directed by your doctorRepeated 14-Day Courses (if needed)you may repeat a 14-day course every 4 monthsdo not take for more than 14 days or more often than every 4 months unless directed by a doctorchildren under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition.

Other Information

  • Read the directions, warnings and package insert before usekeep the carton and package insert. They contain important information.store at 20 – 25°C (68° – 77° F)keep product out of high heat and humidityprotect product from moistureclose cap tightly after use

Inactive Ingredients

FD&C Blue No. 2, gelatin, hydroxypropyl cellulose, iron oxide black, iron oxide red, iron oxide yellow, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol 6000, polysorbate 80, sodium lauryl sulphate, starch (corn), sucrose, sugar spheres, talc, titanium dioxide

* Please review the disclaimer below.

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