Lansoprazole

Dr. Reddy's Laboratories Inc.
Human Otc Drug
NDC 43598-109

Lansoprazole is a drug for further processing labeled by 'Dr. Reddy's Laboratories Inc.'. National Drug Code (NDC) number for Lansoprazole is 43598-109. This drug is available in dosage form of Capsule, Delayed Release. The names of the active, medicinal ingredients in Lansoprazole drug includes Lansoprazole - 15 mg/1 . The currest status of Lansoprazole drug is Active.

Drug Information:

Drug NDC:	43598-109
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Lansoprazole
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Lansoprazole
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Dr. Reddy's Laboratories Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Capsule, Delayed Release
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	LANSOPRAZOLE - 15 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	12 Apr, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	23 Dec, 2024
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	ANDA202194
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.
Listing Expiration Date:	31 Dec, 2024
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Dr. Reddy's Laboratories Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	596843
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
NUI:	N0000175525 N0000000147 N0000009724
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	0K5C5T2QPG
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class MOA:	Proton Pump Inhibitors [MoA]
Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`.
Pharmacologic Class EPC:	Proton Pump Inhibitor [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:	Inhibition Gastric Acid Secretion [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class:	Inhibition Gastric Acid Secretion [PE] Proton Pump Inhibitor [EPC] Proton Pump Inhibitors [MoA]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
43598-109-27	2 BOTTLE in 1 CARTON (43598-109-27) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE	12 Apr, 2022	N/A	No
43598-109-33	3 BOTTLE in 1 CARTON (43598-109-33) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE	12 Apr, 2022	N/A	No
43598-109-52	1 BOTTLE in 1 CARTON (43598-109-52) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE	12 Apr, 2022	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Purpose:

Purpose acid reducer

Product Elements:

Lansoprazole lansoprazole lansoprazole lansoprazole d&c red no. 28 fd&c blue no. 1 fd&c green no. 3 fd&c red no. 40 gelatin hydroxypropyl cellulose, unspecified ferrosoferric oxide low-substituted hydroxypropyl cellulose, unspecified magnesium carbonate methacrylic acid and ethyl acrylate copolymer polyethylene glycol 6000 polysorbate 80 sodium lauryl sulfate starch, corn sucrose talc titanium dioxide rdy;398 opaque cyan colored cap opaque pink colored body container carton

Indications and Usage:

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:

Warnings allergy alert: do not use if you are allergic to lansoprazole lansoprazole may cause severe skin reactions. symptoms may include: skin reddening blisters rash if an allergic reaction occurs, stop use and seek medical help right away. do not use if you have: trouble or pain swallowing food, vomiting with blood, or bloody or black stools. 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 these may be signs of a serious condition. see your doctor ask a doctor before use if you have liver disease had heartburn over 3 months. this may be a sign of a more serious condition. frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach 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 Read more...

if your heartburn continues or worsens you need to take this product for more than 14 days you need to take more than 1 course of treatment every 4 months you get diarrhea you 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) .

Do Not Use:

Dosage and Administration:

Directions adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours 14-day course of treatment swallow 1 capsule with a glass of water before eating in the morning take every day for 14 days do not take more than 1 capsule a day swallow whole. do not crush or chew capsules. do not use for more than 14 days unless directed by your doctor repeated 14-day courses (if needed) you may repeat a 14-day course every 4 months do not take for more than 14 days or more often than every 4 months unless directed by a doctor children under 18 years of age: ask a doctor before use. heartburn in children may sometimes be caused by a serious condition.

Stop Use:

Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days you need to take more than 1 course of treatment every 4 months you get diarrhea you develop a rash or joint pain

Package Label Principal Display Panel:

Principal display panel container : 14's count

Container carton : 14's count

Further Questions:

Questions or comments? call 1-888-375-3784

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.