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United States · US · US:52183-223_e042ef55-48d2-43c6-91d1-55becd1f9f7c

TAGAMET

Orange BookUNIISPLATC A02BA51

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

Identification

ManufacturerPrestige Brands Holdings, Inc.
CountryUS (United States)
ATC codeA02BA51
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5218322330
    3 BLISTER PACK in 1 BOX (52183-223-30) / 10 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
80061L1WGD
CIMETIDINE
RxCUI 2541
Orange Book
N020238
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": {
    "e6401e0a-8612-42e8-bf89-2d67243f28dc": {
      "match": "brand_token",
      "title": "TAGAMET (CIMETIDINE) TABLET [MEDTECH PRODUCTS INC.]",
      "spl_version": "9",
      "published_date": "2024-06-21"
    }
  },
  "productid": "52183-223_e042ef55-48d2-43c6-91d1-55becd1f9f7c",
  "productndc": "52183-223",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "020238",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Jun 19, 1995"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Aug 21, 1996"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CIMETIDINE",
  "proprietary_name": "TAGAMET",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020238",
  "marketing_category": "NDA",
  "nonproprietary_name": "cimetidine",
  "start_marketing_date": "20230201",
  "active_numerator_strength": "200"
}

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