cimetidine

Generic: cimetidine

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

Drug Facts

Product Profile

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

cimetidine 200 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-0053
Product ID 0378-0053_14717870-5f24-4002-ada5-1c5a44cc2be9
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 03780053
Hyphenated Format 0378-0053

Supplemental Identifiers

RxCUI
197505 197506 197507 197508
UPC
0303780541016 0303780317017 0303780053014 0303780372016
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 ANDA074246 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0053-01)
source: ndc

Packages (1)

0378-0053-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0053-01)

Ingredients (1)

cimetidine (200 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": "14717870-5f24-4002-ada5-1c5a44cc2be9", "openfda": {"nui": ["N0000000151", "N0000175784"], "upc": ["0303780541016", "0303780317017", "0303780053014", "0303780372016"], "unii": ["80061L1WGD"], "rxcui": ["197505", "197506", "197507", "197508"], "spl_set_id": ["06c0a509-026f-44e0-9975-a94a8de51d43"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0053-01)", "package_ndc": "0378-0053-01", "marketing_start_date": "19940517"}], "brand_name": "Cimetidine", "product_id": "0378-0053_14717870-5f24-4002-ada5-1c5a44cc2be9", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "0378-0053", "generic_name": "cimetidine", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cimetidine", "active_ingredients": [{"name": "CIMETIDINE", "strength": "200 mg/1"}], "application_number": "ANDA074246", "marketing_category": "ANDA", "marketing_start_date": "19940517", "listing_expiration_date": "20261231"}