cimetidine

Generic: cimetidine

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cimetidine
Generic Name cimetidine
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cimetidine 400 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 55289-581
Product ID 55289-581_419aec97-c220-0c91-e063-6294a90a67b0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074246
Listing Expiration 2026-12-31
Marketing Start 1994-05-17

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 55289581
Hyphenated Format 55289-581

Supplemental Identifiers

RxCUI
197507
UNII
80061L1WGD
NUI
N0000000151 N0000175784

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 ANDA074246 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-581-10)
  • 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-581-20)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-581-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-581-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-581-90)
source: ndc

Packages (5)

55289-581-10 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-581-10) 55289-581-20 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-581-20) 55289-581-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-581-30) 55289-581-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-581-60) 55289-581-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-581-90)

Ingredients (1)

cimetidine (400 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": "419aec97-c220-0c91-e063-6294a90a67b0", "openfda": {"nui": ["N0000000151", "N0000175784"], "unii": ["80061L1WGD"], "rxcui": ["197507"], "spl_set_id": ["28fd7158-a617-436a-8f5c-71ffbaafe527"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-581-10)", "package_ndc": "55289-581-10", "marketing_start_date": "20151102"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-581-20)", "package_ndc": "55289-581-20", "marketing_start_date": "20151102"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-581-30)", "package_ndc": "55289-581-30", "marketing_start_date": "20151102"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-581-60)", "package_ndc": "55289-581-60", "marketing_start_date": "20151102"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-581-90)", "package_ndc": "55289-581-90", "marketing_start_date": "20151102"}], "brand_name": "Cimetidine", "product_id": "55289-581_419aec97-c220-0c91-e063-6294a90a67b0", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "55289-581", "generic_name": "cimetidine", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cimetidine", "active_ingredients": [{"name": "CIMETIDINE", "strength": "400 mg/1"}], "application_number": "ANDA074246", "marketing_category": "ANDA", "marketing_start_date": "19940517", "listing_expiration_date": "20261231"}