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United States · US · US:0713-0885_2d02613b-bc31-bf2c-e063-6394a90a32cc

Clomid

Orange BookUNIISPLATC G03GB02

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

Identification

ManufacturerCosette Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeG03GB02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0713088509
    1 BLISTER PACK in 1 CARTON (0713-0885-09) / 10 TABLET in 1 BLISTER PACK
  • ndc11
    0713088530
    3 BLISTER PACK in 1 CARTON (0713-0885-30) / 10 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
1B8447E7YI
CLOMIPHENE CITRATE
RxCUI 142431
Orange Book
A075528
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "1B8447E7YI",
    "rxcui": "142431",
    "inchikey": null,
    "display_name": "CLOMIPHENE CITRATE",
    "substance_type": "mixture",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "2ca373c1-4dba-4126-8616-5c533d606fe5": {
      "match": "brand_token",
      "title": "CLOMID (CLOMIPHENE CITRATE) TABLET [COSETTE PHARMACEUTICALS, INC.]",
      "spl_version": "3",
      "published_date": "2025-02-03"
    }
  },
  "productid": "0713-0885_2d02613b-bc31-bf2c-e063-6394a90a32cc",
  "productndc": "0713-0885",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "075528",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Aug 30, 1999"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLOMIPHENE CITRATE",
  "proprietary_name": "Clomid",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075528",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clomiphene Citrate",
  "start_marketing_date": "20220909",
  "active_numerator_strength": "50"
}

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