cimetidine hydrochloride

Generic: cimetidine hydrochloride

Labeler: chartwell governmental & specialty rx, llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cimetidine hydrochloride
Generic Name cimetidine hydrochloride
Labeler chartwell governmental & specialty rx, llc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

cimetidine hydrochloride 300 mg/5mL

Manufacturer
Chartwell Governmental & Specialty RX, LLC.

Identifiers & Regulatory

Product NDC 68999-809
Product ID 68999-809_42c607ee-eb27-a72c-e063-6394a90a653c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074251
Listing Expiration 2026-12-31
Marketing Start 1994-12-22

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 68999809
Hyphenated Format 68999-809

Supplemental Identifiers

RxCUI
212787
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 ANDA074251 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/5mL
source: ndc
Packaging
  • 2 TRAY in 1 BOX (68999-809-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-809-05)
source: ndc

Packages (1)

68999-809-24 2 TRAY in 1 BOX (68999-809-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-809-05)

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": "42c607ee-eb27-a72c-e063-6394a90a653c", "openfda": {"unii": ["WF10491673"], "rxcui": ["212787"], "spl_set_id": ["e40bb1f6-338a-42e7-9217-8c32d14ccfd3"], "manufacturer_name": ["Chartwell Governmental & Specialty RX, LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TRAY in 1 BOX (68999-809-24)  / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-809-05)", "package_ndc": "68999-809-24", "marketing_start_date": "20251023"}], "brand_name": "CIMETIDINE HYDROCHLORIDE", "product_id": "68999-809_42c607ee-eb27-a72c-e063-6394a90a653c", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "68999-809", "generic_name": "CIMETIDINE HYDROCHLORIDE", "labeler_name": "Chartwell Governmental & Specialty RX, LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CIMETIDINE HYDROCHLORIDE", "active_ingredients": [{"name": "CIMETIDINE HYDROCHLORIDE", "strength": "300 mg/5mL"}], "application_number": "ANDA074251", "marketing_category": "ANDA", "marketing_start_date": "19941222", "listing_expiration_date": "20261231"}