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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

  • ndc11
    0121102508
    237 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

Other records sharing ATC code A02BA51.

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