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Lansoprazole - Medication Information

Product NDC Code 65841-769
Drug Name

Lansoprazole

Type Generic
Pharm Class Inhibition Gastric Acid Secretion [PE],
Proton Pump Inhibitor [EPC],
Proton Pump Inhibitors [MoA]
Active Ingredients
Lansoprazole 15 mg/1
Route ORAL
Dosage Form CAPSULE, DELAYED RELEASE PELLETS
RxCUI drug identifier 311277,
596843
Application Number ANDA202366
Labeler Name Zydus Lifesciences Limited
Packages
Package NDC Code Description
65841-769-06 30 capsule, delayed release pellets in 1 bottle (65841-769-06)
65841-769-10 1000 capsule, delayed release pellets in 1 bottle (65841-769-10)
65841-769-30 10 blister pack in 1 carton (65841-769-30) / 10 capsule, delayed release pellets in 1 blister pack
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Spl product data elements

Usually a list of ingredients in a drug product.
lansoprazole lansoprazole LANSOPRAZOLE LANSOPRAZOLE ALCOHOL AMMONIA BUTYL ALCOHOL D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 FERROSOFERRIC OXIDE HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSES ISOPROPYL ALCOHOL SHELLAC MAGNESIUM CARBONATE METHACRYLIC ACID POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 PROPYLENE GLYCOL WATER GELATIN SUCROSE TALC TITANIUM DIOXIDE POTASSIUM HYDROXIDE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED STARCH, CORN PINK WHITE CAPSULE ZA;50;15mg lansoprazole lansoprazole LANSOPRAZOLE LANSOPRAZOLE ALCOHOL AMMONIA BUTYL ALCOHOL D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 FERROSOFERRIC OXIDE HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSES ISOPROPYL ALCOHOL SHELLAC MAGNESIUM CARBONATE METHACRYLIC ACID POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 PROPYLENE GLYCOL WATER GELATIN SUCROSE TALC TITANIUM DIOXIDE POTASSIUM HYDROXIDE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED STARCH, CORN PINK WHITE CAPSULE ZA;51;30mg

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
NDC 65841-769-10 in bottle of 1000 Capsules Lansoprazole Delayed-release Capsules USP, 15 mg Rx only 1000 Capsules NDC 65841-770-10 in bottle of 1000 Capsules Lansoprazole Delayed-release Capsules USP, 30 mg Rx only 1000 Capsules Structured formula for lansoprazole Structured formula for lansoprazole

Spl medguide

Information about the patient medication guide that accompanies the drug product. Certain drugs must be dispensed with an accompanying medication guide. This field may contain information about when to consult the medication guide and the contents of the medication guide.
Manufactured by: Cadila Healthcare Ltd. India. SPL MEDGUIDE

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API