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United States · US · US:64980-690_621c3a1f-d194-4381-bde0-1574f108ac4e

Clomiphene Citrate

Orange BookUNIISPLATC G03GB02

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

Identification

ManufacturerRISING PHARMA HOLDINGS, INC.
CountryUS (United States)
ATC codeG03GB02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6498069001
    10 TABLET in 1 BOTTLE (64980-690-01)
  • ndc11
    6498069003
    30 TABLET in 1 BOTTLE (64980-690-03)
  • ndc11
    6498069090
    1 BLISTER PACK in 1 CARTON (64980-690-90) / 10 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
1B8447E7YI
CLOMIPHENE CITRATE
RxCUI 142431
Orange Book
A216739
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": {
    "79f64995-7425-44c6-9f44-f7d20daeff65": {
      "match": "brand_token",
      "title": "CLOMIPHENE CITRATE TABLET [ACCORD HEALTHCARE INC.]",
      "spl_version": "3",
      "published_date": "2025-12-02"
    }
  },
  "productid": "64980-690_621c3a1f-d194-4381-bde0-1574f108ac4e",
  "productndc": "64980-690",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "216739",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Nov 8, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLOMIPHENE CITRATE",
  "proprietary_name": "Clomiphene Citrate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA216739",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clomiphene Citrtae",
  "start_marketing_date": "20241119",
  "active_numerator_strength": "50"
}

Related drugs

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