lansoprazole

Generic: lansoprazole

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lansoprazole
Generic Name lansoprazole
Labeler mylan pharmaceuticals inc.
Dosage Form TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Routes
ORAL
Active Ingredients

lansoprazole 30 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-6982
Product ID 0378-6982_00959575-41db-4810-b59c-1edd08568b17
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202396
Listing Expiration 2026-12-31
Marketing Start 2018-11-29

Pharmacologic Class

Established (EPC)
proton pump inhibitor [epc]
Mechanism of Action
proton pump inhibitors [moa]
Physiologic Effect
inhibition gastric acid secretion [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03786982
Hyphenated Format 0378-6982

Supplemental Identifiers

RxCUI
351260 351261
UNII
0K5C5T2QPG
NUI
N0000175525 N0000000147 N0000009724

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name lansoprazole (source: ndc)
Generic Name lansoprazole (source: ndc)
Application Number ANDA202396 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 2 CARTON in 1 BOX (0378-6982-88) / 5 BLISTER PACK in 1 CARTON (0378-6982-85) / 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK (0378-6982-32)
source: ndc

Packages (1)

0378-6982-88 2 CARTON in 1 BOX (0378-6982-88) / 5 BLISTER PACK in 1 CARTON (0378-6982-85) / 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK (0378-6982-32)

Ingredients (1)

lansoprazole (30 mg/1)

Linked Drug Pages (1)

Lansoprazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "00959575-41db-4810-b59c-1edd08568b17", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000009724"], "unii": ["0K5C5T2QPG"], "rxcui": ["351260", "351261"], "spl_set_id": ["20ff347c-ca18-497b-948d-1145035f2ffc"], "pharm_class_pe": ["Inhibition Gastric Acid Secretion [PE]"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 CARTON in 1 BOX (0378-6982-88)  / 5 BLISTER PACK in 1 CARTON (0378-6982-85)  / 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK (0378-6982-32)", "package_ndc": "0378-6982-88", "marketing_start_date": "20181129"}], "brand_name": "Lansoprazole", "product_id": "0378-6982_00959575-41db-4810-b59c-1edd08568b17", "dosage_form": "TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE", "pharm_class": ["Inhibition Gastric Acid Secretion [PE]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "0378-6982", "generic_name": "lansoprazole", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lansoprazole", "active_ingredients": [{"name": "LANSOPRAZOLE", "strength": "30 mg/1"}], "application_number": "ANDA202396", "marketing_category": "ANDA", "marketing_start_date": "20181129", "listing_expiration_date": "20261231"}