topcare lansoprazole

Generic: lansoprazole

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name topcare lansoprazole
Generic Name lansoprazole
Labeler topco associates llc
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

lansoprazole 15 mg/1

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-392
Product ID 36800-392_f5217e63-e0c1-4899-8bf0-e480d65e282f
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA202319
Listing Expiration 2026-12-31
Marketing Start 2021-07-29

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 36800392
Hyphenated Format 36800-392

Supplemental Identifiers

RxCUI
596843
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 topcare lansoprazole (source: ndc)
Generic Name lansoprazole (source: ndc)
Application Number ANDA202319 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (36800-392-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
  • 3 BOTTLE in 1 CARTON (36800-392-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
source: ndc

Packages (2)

36800-392-01 1 BOTTLE in 1 CARTON (36800-392-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE 36800-392-03 3 BOTTLE in 1 CARTON (36800-392-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

Ingredients (1)

lansoprazole (15 mg/1)

Linked Drug Pages (1)

topcare lansoprazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f5217e63-e0c1-4899-8bf0-e480d65e282f", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000009724"], "unii": ["0K5C5T2QPG"], "rxcui": ["596843"], "spl_set_id": ["73aec019-5337-48a4-b95c-993fff9cfc2a"], "pharm_class_pe": ["Inhibition Gastric Acid Secretion [PE]"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-392-01)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "36800-392-01", "marketing_start_date": "20210729"}, {"sample": false, "description": "3 BOTTLE in 1 CARTON (36800-392-03)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "36800-392-03", "marketing_start_date": "20210729"}], "brand_name": "topcare lansoprazole", "product_id": "36800-392_f5217e63-e0c1-4899-8bf0-e480d65e282f", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Inhibition Gastric Acid Secretion [PE]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "36800-392", "generic_name": "Lansoprazole", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "topcare lansoprazole", "active_ingredients": [{"name": "LANSOPRAZOLE", "strength": "15 mg/1"}], "application_number": "ANDA202319", "marketing_category": "ANDA", "marketing_start_date": "20210729", "listing_expiration_date": "20261231"}