lansoprazole

Generic: lansoprazole

Labeler: leader/ cardinal health 110, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lansoprazole
Generic Name lansoprazole
Labeler leader/ cardinal health 110, inc.
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

lansoprazole 15 mg/1

Manufacturer
LEADER/ Cardinal Health 110, Inc.

Identifiers & Regulatory

Product NDC 70000-0612
Product ID 70000-0612_8540b91a-377b-abac-70c6-5433b7167307
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA202194
Listing Expiration 2026-12-31
Marketing Start 2022-10-26

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 700000612
Hyphenated Format 70000-0612

Supplemental Identifiers

RxCUI
596843
UNII
0K5C5T2QPG
NUI
N0000175525 N0000000147 N0000009724

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 ANDA202194 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70000-0612-1) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
  • 3 BOTTLE in 1 CARTON (70000-0612-3) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
source: ndc

Packages (2)

70000-0612-1 1 BOTTLE in 1 CARTON (70000-0612-1) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE 70000-0612-3 3 BOTTLE in 1 CARTON (70000-0612-3) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

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": "8540b91a-377b-abac-70c6-5433b7167307", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000009724"], "unii": ["0K5C5T2QPG"], "rxcui": ["596843"], "spl_set_id": ["486838cd-17ee-c2df-4e05-aa6106dd8fd8"], "pharm_class_pe": ["Inhibition Gastric Acid Secretion [PE]"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]"], "manufacturer_name": ["LEADER/ Cardinal Health 110, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70000-0612-1)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "70000-0612-1", "marketing_start_date": "20221026"}, {"sample": false, "description": "3 BOTTLE in 1 CARTON (70000-0612-3)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "70000-0612-3", "marketing_start_date": "20221026"}], "brand_name": "Lansoprazole", "product_id": "70000-0612_8540b91a-377b-abac-70c6-5433b7167307", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Inhibition Gastric Acid Secretion [PE]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "70000-0612", "generic_name": "Lansoprazole", "labeler_name": "LEADER/ Cardinal Health 110, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Lansoprazole", "active_ingredients": [{"name": "LANSOPRAZOLE", "strength": "15 mg/1"}], "application_number": "ANDA202194", "marketing_category": "ANDA", "marketing_start_date": "20221026", "listing_expiration_date": "20261231"}