cimetidine

Generic: cimetidine

Labeler: bionpharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cimetidine
Generic Name cimetidine
Labeler bionpharma inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cimetidine 800 mg/1

Manufacturer
Bionpharma Inc.

Identifiers & Regulatory

Product NDC 69452-326
Product ID 69452-326_2d7b7608-a2bd-dfde-e063-6294a90afa2c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218220
Listing Expiration 2026-12-31
Marketing Start 2025-03-01

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 69452326
Hyphenated Format 69452-326

Supplemental Identifiers

RxCUI
197505 197506 197507 197508
UNII
80061L1WGD
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 cimetidine (source: ndc)
Generic Name cimetidine (source: ndc)
Application Number ANDA218220 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (69452-326-20)
  • 500 TABLET, FILM COATED in 1 BOTTLE (69452-326-30)
source: ndc

Packages (2)

69452-326-20 100 TABLET, FILM COATED in 1 BOTTLE (69452-326-20) 69452-326-30 500 TABLET, FILM COATED in 1 BOTTLE (69452-326-30)

Ingredients (1)

cimetidine (800 mg/1)

Linked Drug Pages (1)

Cimetidine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2d7b7608-a2bd-dfde-e063-6294a90afa2c", "openfda": {"nui": ["N0000000151", "N0000175784"], "unii": ["80061L1WGD"], "rxcui": ["197505", "197506", "197507", "197508"], "spl_set_id": ["2d7b6e7d-cf01-70a2-e063-6394a90afbe6"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Bionpharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (69452-326-20)", "package_ndc": "69452-326-20", "marketing_start_date": "20250301"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (69452-326-30)", "package_ndc": "69452-326-30", "marketing_start_date": "20250301"}], "brand_name": "Cimetidine", "product_id": "69452-326_2d7b7608-a2bd-dfde-e063-6294a90afa2c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "69452-326", "generic_name": "cimetidine", "labeler_name": "Bionpharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cimetidine", "active_ingredients": [{"name": "CIMETIDINE", "strength": "800 mg/1"}], "application_number": "ANDA218220", "marketing_category": "ANDA", "marketing_start_date": "20250301", "listing_expiration_date": "20261231"}