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 CAPSULE, DELAYED RELEASE PELLETS
Routes
ORAL
Active Ingredients

lansoprazole 15 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-8015
Product ID 0378-8015_810def72-c1da-4c4d-9939-32b29be79e0c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090763
Listing Expiration 2026-12-31
Marketing Start 2009-11-10

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 03788015
Hyphenated Format 0378-8015

Supplemental Identifiers

RxCUI
311277 596843
UPC
0303788030932 0303788015939
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 ANDA090763 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-8015-93)
source: ndc

Packages (1)

0378-8015-93 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-8015-93)

Ingredients (1)

lansoprazole (15 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": "810def72-c1da-4c4d-9939-32b29be79e0c", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000009724"], "upc": ["0303788030932", "0303788015939"], "unii": ["0K5C5T2QPG"], "rxcui": ["311277", "596843"], "spl_set_id": ["c8fa7401-907f-41b6-a2e1-f4bc214f2cdf"], "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": "30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-8015-93)", "package_ndc": "0378-8015-93", "marketing_start_date": "20091110"}], "brand_name": "Lansoprazole", "product_id": "0378-8015_810def72-c1da-4c4d-9939-32b29be79e0c", "dosage_form": "CAPSULE, DELAYED RELEASE PELLETS", "pharm_class": ["Inhibition Gastric Acid Secretion [PE]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "0378-8015", "generic_name": "lansoprazole", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lansoprazole", "active_ingredients": [{"name": "LANSOPRAZOLE", "strength": "15 mg/1"}], "application_number": "ANDA090763", "marketing_category": "ANDA", "marketing_start_date": "20091110", "listing_expiration_date": "20261231"}