lansoprazole

Generic: lansoprazole

Labeler: rugby laboratories, inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lansoprazole
Generic Name lansoprazole
Labeler rugby laboratories, inc
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

lansoprazole 15 mg/1

Manufacturer
Rugby Laboratories, Inc

Identifiers & Regulatory

Product NDC 0536-1368
Product ID 0536-1368_ef21368f-e4df-c863-8e40-767c21fcf81b
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 05361368
Hyphenated Format 0536-1368

Supplemental Identifiers

RxCUI
596843
UPC
0305361368883
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 ANDA202194 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 3 BOTTLE in 1 CARTON (0536-1368-13) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
source: ndc

Packages (1)

0536-1368-13 3 BOTTLE in 1 CARTON (0536-1368-13) / 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": "ef21368f-e4df-c863-8e40-767c21fcf81b", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000009724"], "upc": ["0305361368883"], "unii": ["0K5C5T2QPG"], "rxcui": ["596843"], "spl_set_id": ["aa95216c-8985-d160-1743-ba168a35177f"], "pharm_class_pe": ["Inhibition Gastric Acid Secretion [PE]"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]"], "manufacturer_name": ["Rugby Laboratories, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BOTTLE in 1 CARTON (0536-1368-13)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "0536-1368-13", "marketing_start_date": "20221026"}], "brand_name": "Lansoprazole", "product_id": "0536-1368_ef21368f-e4df-c863-8e40-767c21fcf81b", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Inhibition Gastric Acid Secretion [PE]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "0536-1368", "generic_name": "Lansoprazole", "labeler_name": "Rugby Laboratories, 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"}