cimetidine

Generic: cimetidine

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

cimetidine 300 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-8192
Product ID 0093-8192_e1f40596-aa5b-46a4-b2aa-add1150ac3a1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074151
Listing Expiration 2026-12-31
Marketing Start 2003-11-24

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 00938192
Hyphenated Format 0093-8192

Supplemental Identifiers

RxCUI
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 ANDA074151 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (0093-8192-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (0093-8192-05)
source: ndc

Packages (2)

0093-8192-01 100 TABLET, FILM COATED in 1 BOTTLE (0093-8192-01) 0093-8192-05 500 TABLET, FILM COATED in 1 BOTTLE (0093-8192-05)

Ingredients (1)

cimetidine (300 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": "e1f40596-aa5b-46a4-b2aa-add1150ac3a1", "openfda": {"nui": ["N0000000151", "N0000175784"], "unii": ["80061L1WGD"], "rxcui": ["197506", "197507", "197508"], "spl_set_id": ["496e258d-a5fd-42da-9a86-73afc8be359b"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (0093-8192-01)", "package_ndc": "0093-8192-01", "marketing_start_date": "20031124"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (0093-8192-05)", "package_ndc": "0093-8192-05", "marketing_start_date": "20040128"}], "brand_name": "Cimetidine", "product_id": "0093-8192_e1f40596-aa5b-46a4-b2aa-add1150ac3a1", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "0093-8192", "generic_name": "Cimetidine", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cimetidine", "active_ingredients": [{"name": "CIMETIDINE", "strength": "300 mg/1"}], "application_number": "ANDA074151", "marketing_category": "ANDA", "marketing_start_date": "20031124", "listing_expiration_date": "20261231"}