cimetidine hydrochloride

Generic: cimetidine hydrochloride

Labeler: pai holdings, llc dba pai pharma
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cimetidine hydrochloride
Generic Name cimetidine hydrochloride
Labeler pai holdings, llc dba pai pharma
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

cimetidine hydrochloride 300 mg/5mL

Manufacturer
PAI Holdings, LLC dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-1025
Product ID 0121-1025_55abdac4-2b7c-4163-bf5f-d2e934108ba6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074664
Listing Expiration 2026-12-31
Marketing Start 2025-01-09

Pharmacologic Class

Classes
histamine h2 receptor antagonists [moa] histamine-2 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01211025
Hyphenated Format 0121-1025

Supplemental Identifiers

RxCUI
212787
UPC
0301211025081
UNII
WF10491673

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 hydrochloride (source: ndc)
Generic Name cimetidine hydrochloride (source: ndc)
Application Number ANDA074664 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/5mL
source: ndc
Packaging
  • 237 mL in 1 BOTTLE (0121-1025-08)
source: ndc

Packages (1)

0121-1025-08 237 mL in 1 BOTTLE (0121-1025-08)

Ingredients (1)

cimetidine hydrochloride (300 mg/5mL)

Linked Drug Pages (1)

Cimetidine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "55abdac4-2b7c-4163-bf5f-d2e934108ba6", "openfda": {"upc": ["0301211025081"], "unii": ["WF10491673"], "rxcui": ["212787"], "spl_set_id": ["b8b50bd9-bc1b-4da5-96c5-8eb917c8937f"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "237 mL in 1 BOTTLE (0121-1025-08)", "package_ndc": "0121-1025-08", "marketing_start_date": "20250109"}], "brand_name": "Cimetidine Hydrochloride", "product_id": "0121-1025_55abdac4-2b7c-4163-bf5f-d2e934108ba6", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "0121-1025", "generic_name": "Cimetidine Hydrochloride", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cimetidine Hydrochloride", "active_ingredients": [{"name": "CIMETIDINE HYDROCHLORIDE", "strength": "300 mg/5mL"}], "application_number": "ANDA074664", "marketing_category": "ANDA", "marketing_start_date": "20250109", "listing_expiration_date": "20261231"}