topcare acid reducer

Generic: famotidine

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

Drug Facts

Product Profile

Brand Name topcare acid reducer
Generic Name famotidine
Labeler topco associates llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

famotidine 20 mg/1

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 76162-300
Product ID 76162-300_8a5a69da-3a67-4ecc-97d1-39ffea001485
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA077351
Listing Expiration 2026-12-31
Marketing Start 2022-09-25

Pharmacologic Class

Established (EPC)
histamine-2 receptor antagonist [epc]
Mechanism of Action
histamine h2 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76162300
Hyphenated Format 76162-300

Supplemental Identifiers

RxCUI
310273
UNII
5QZO15J2Z8
NUI
N0000000151 N0000175784

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 acid reducer (source: ndc)
Generic Name famotidine (source: ndc)
Application Number ANDA077351 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (76162-300-71) / 50 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (1)

76162-300-71 1 BOTTLE in 1 CARTON (76162-300-71) / 50 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

famotidine (20 mg/1)

Linked Drug Pages (1)

topcare acid reducer ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8a5a69da-3a67-4ecc-97d1-39ffea001485", "openfda": {"nui": ["N0000000151", "N0000175784"], "unii": ["5QZO15J2Z8"], "rxcui": ["310273"], "spl_set_id": ["7824fdab-cdd5-457d-9b14-b82b19ea9529"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (76162-300-71)  / 50 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "76162-300-71", "marketing_start_date": "20220925"}], "brand_name": "topcare acid reducer", "product_id": "76162-300_8a5a69da-3a67-4ecc-97d1-39ffea001485", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "76162-300", "generic_name": "famotidine", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "topcare acid reducer", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "20 mg/1"}], "application_number": "ANDA077351", "marketing_category": "ANDA", "marketing_start_date": "20220925", "listing_expiration_date": "20261231"}