cimetidine hydrochloride

Generic: cimetidine hydrochloride

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

cimetidine hydrochloride 300 mg/5mL

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-809
Product ID 62135-809_4a162075-ab76-d848-e063-6294a90aaa9b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074251
Listing Expiration 2027-12-31
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 62135809
Hyphenated Format 62135-809

Supplemental Identifiers

RxCUI
212787
UPC
0362135809379
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 (62135-809-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-809-05)
  • 237 mL in 1 BOTTLE (62135-809-37)
source: ndc

Packages (2)

62135-809-24 2 TRAY in 1 BOX (62135-809-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-809-05) 62135-809-37 237 mL in 1 BOTTLE (62135-809-37)

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": "4a162075-ab76-d848-e063-6294a90aaa9b", "openfda": {"upc": ["0362135809379"], "unii": ["WF10491673"], "rxcui": ["212787"], "spl_set_id": ["d1d73350-4e7e-428a-90a5-6000fd373a4f"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TRAY in 1 BOX (62135-809-24)  / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-809-05)", "package_ndc": "62135-809-24", "marketing_start_date": "20241022"}, {"sample": false, "description": "237 mL in 1 BOTTLE (62135-809-37)", "package_ndc": "62135-809-37", "marketing_start_date": "20240506"}], "brand_name": "CIMETIDINE HYDROCHLORIDE", "product_id": "62135-809_4a162075-ab76-d848-e063-6294a90aaa9b", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "62135-809", "generic_name": "CIMETIDINE HYDROCHLORIDE", "labeler_name": "Chartwell 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": "20271231"}