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United States · US · US:0093-8204_e1f40596-aa5b-46a4-b2aa-add1150ac3a1

Cimetidine

Orange BookUNIISPLATC A02BA51

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerTeva Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeA02BA51
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0093820401
    100 TABLET, FILM COATED in 1 BOTTLE (0093-8204-01)
  • ndc11
    0093820405
    500 TABLET, FILM COATED in 1 BOTTLE (0093-8204-05)

Annotations

UNII (FDA Substance ID)
80061L1WGD
CIMETIDINE
RxCUI 2541
Orange Book
A074151
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "80061L1WGD",
    "rxcui": "2541",
    "inchikey": "AQIXAKUUQRKLND-UHFFFAOYSA-N",
    "display_name": "CIMETIDINE",
    "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": "0093-8204_e1f40596-aa5b-46a4-b2aa-add1150ac3a1",
  "productndc": "0093-8204",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "074151",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "May 17, 1994"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "May 17, 1994"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "003",
        "approval_date": "May 17, 1994"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CIMETIDINE",
  "proprietary_name": "Cimetidine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA074151",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cimetidine",
  "start_marketing_date": "20040202",
  "active_numerator_strength": "400"
}

Related drugs

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