lansoprazole

Generic: lansoprazole

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

Drug Facts

Product Profile

Brand Name lansoprazole
Generic Name lansoprazole
Labeler zydus pharmaceuticals usa inc.
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

lansoprazole 15 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-771
Product ID 68382-771_3de4f129-dc87-48e1-b934-b2a038df8cf7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200816
Listing Expiration 2026-12-31
Marketing Start 2018-11-30

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 68382771
Hyphenated Format 68382-771

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 ANDA200816 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (68382-771-77) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68382-771-30)
source: ndc

Packages (1)

68382-771-77 10 BLISTER PACK in 1 CARTON (68382-771-77) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68382-771-30)

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": "3de4f129-dc87-48e1-b934-b2a038df8cf7", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000009724"], "unii": ["0K5C5T2QPG"], "rxcui": ["351260", "351261"], "spl_set_id": ["9b3869ad-f2f7-4954-b75c-5c23b8951635"], "pharm_class_pe": ["Inhibition Gastric Acid Secretion [PE]"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68382-771-77)  / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68382-771-30)", "package_ndc": "68382-771-77", "marketing_start_date": "20181130"}], "brand_name": "LANSOPRAZOLE", "product_id": "68382-771_3de4f129-dc87-48e1-b934-b2a038df8cf7", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Inhibition Gastric Acid Secretion [PE]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "68382-771", "generic_name": "LANSOPRAZOLE", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LANSOPRAZOLE", "active_ingredients": [{"name": "LANSOPRAZOLE", "strength": "15 mg/1"}], "application_number": "ANDA200816", "marketing_category": "ANDA", "marketing_start_date": "20181130", "listing_expiration_date": "20261231"}