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United States · US · US:0121-1025_55abdac4-2b7c-4163-bf5f-d2e934108ba6
Cimetidine Hydrochloride
Orange BookUNIISPLATC A02BA51
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPAI Holdings, LLC dba PAI Pharma
CountryUS (United States)
ATC codeA02BA51
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc110121102508237 mL in 1 BOTTLE (0121-1025-08)
Annotations
UNII (FDA Substance ID)
WF10491673
CIMETIDINE HYDROCHLORIDE
RxCUI 91251
Orange Book
A074664
AA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "WF10491673",
"rxcui": "91251",
"inchikey": "QJHCNBWLPSXHBL-UHFFFAOYSA-N",
"display_name": "CIMETIDINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"0ab5ea2b-bd2f-49ec-9e92-033bed998797": {
"match": "brand_token",
"title": "CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]",
"spl_version": "1008",
"published_date": "2026-03-10"
}
},
"productid": "0121-1025_55abdac4-2b7c-4163-bf5f-d2e934108ba6",
"productndc": "0121-1025",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "074664",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "EQ 300MG BASE/5ML",
"product_no": "001",
"approval_date": "Oct 28, 1997"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CIMETIDINE HYDROCHLORIDE",
"proprietary_name": "Cimetidine Hydrochloride",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA074664",
"marketing_category": "ANDA",
"nonproprietary_name": "Cimetidine Hydrochloride",
"start_marketing_date": "20250109",
"active_numerator_strength": "300"
}Related drugs
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