Cimetidine

Orange BookUNIISPLATC A02BA51

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerMylan Pharmaceuticals Inc.

CountryUS (United States)

ATC codeA02BA51

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0378054101
100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0541-01)

Annotations

UNII (FDA Substance ID)

80061L1WGD

CIMETIDINE

RxCUI 2541

Orange Book

A074246

ABABABAB

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": "0378-0541_14717870-5f24-4002-ada5-1c5a44cc2be9",
  "productndc": "0378-0541",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "074246",
    "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"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "800MG",
        "product_no": "004",
        "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": "ANDA074246",
  "marketing_category": "ANDA",
  "nonproprietary_name": "cimetidine",
  "start_marketing_date": "19940517",
  "active_numerator_strength": "800"
}

Related drugs

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