cimetidine

Generic: cimetidine

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cimetidine
Generic Name cimetidine
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cimetidine 800 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-826
Product ID 59651-826_ebd53065-c080-4045-a398-64d3f3b1460f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218997
Listing Expiration 2026-12-31
Marketing Start 2024-11-12

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 59651826
Hyphenated Format 59651-826

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 ANDA218997 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (59651-826-01)
source: ndc

Packages (1)

59651-826-01 100 TABLET, FILM COATED in 1 BOTTLE (59651-826-01)

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": "ebd53065-c080-4045-a398-64d3f3b1460f", "openfda": {"nui": ["N0000000151", "N0000175784"], "unii": ["80061L1WGD"], "rxcui": ["197505", "197506", "197507", "197508"], "spl_set_id": ["ebd53065-c080-4045-a398-64d3f3b1460f"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (59651-826-01)", "package_ndc": "59651-826-01", "marketing_start_date": "20241112"}], "brand_name": "CIMETIDINE", "product_id": "59651-826_ebd53065-c080-4045-a398-64d3f3b1460f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "59651-826", "generic_name": "CIMETIDINE", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CIMETIDINE", "active_ingredients": [{"name": "CIMETIDINE", "strength": "800 mg/1"}], "application_number": "ANDA218997", "marketing_category": "ANDA", "marketing_start_date": "20241112", "listing_expiration_date": "20261231"}