Cimetidine

Orange BookUNIISPLATC A02BA51

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

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeA02BA51

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
5528958110
10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-581-10)
ndc11
5528958120
20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-581-20)
ndc11
5528958130
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-581-30)
ndc11
5528958160
60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-581-60)
ndc11
5528958190
90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-581-90)

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": "55289-581_419aec97-c220-0c91-e063-6294a90a67b0",
  "productndc": "55289-581",
  "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": "400"
}

Related drugs

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