clomiphene citrate

Generic: clomiphene citrate

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clomiphene citrate
Generic Name clomiphene citrate
Labeler ani pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

clomiphene citrate 50 mg/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-825
Product ID 70954-825_b56e04f0-490d-4f10-a0ed-31c288f4f4c5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219781
Listing Expiration 2026-12-31
Marketing Start 2025-10-17

Pharmacologic Class

Classes
estrogen agonist/antagonist [epc] selective estrogen receptor modulators [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70954825
Hyphenated Format 70954-825

Supplemental Identifiers

RxCUI
1093060
UPC
0370954825302
UNII
1B8447E7YI

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name clomiphene citrate (source: ndc)
Generic Name clomiphene citrate (source: ndc)
Application Number ANDA219781 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (70954-825-20) / 1 TABLET in 1 BLISTER PACK (70954-825-10)
  • 30 BLISTER PACK in 1 CARTON (70954-825-30) / 1 TABLET in 1 BLISTER PACK (70954-825-10)
source: ndc

Packages (2)

70954-825-20 10 BLISTER PACK in 1 CARTON (70954-825-20) / 1 TABLET in 1 BLISTER PACK (70954-825-10) 70954-825-30 30 BLISTER PACK in 1 CARTON (70954-825-30) / 1 TABLET in 1 BLISTER PACK (70954-825-10)

Ingredients (1)

clomiphene citrate (50 mg/1)

Linked Drug Pages (1)

Clomiphene citrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b56e04f0-490d-4f10-a0ed-31c288f4f4c5", "openfda": {"upc": ["0370954825302"], "unii": ["1B8447E7YI"], "rxcui": ["1093060"], "spl_set_id": ["b56e04f0-490d-4f10-a0ed-31c288f4f4c5"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (70954-825-20)  / 1 TABLET in 1 BLISTER PACK (70954-825-10)", "package_ndc": "70954-825-20", "marketing_start_date": "20251017"}, {"sample": false, "description": "30 BLISTER PACK in 1 CARTON (70954-825-30)  / 1 TABLET in 1 BLISTER PACK (70954-825-10)", "package_ndc": "70954-825-30", "marketing_start_date": "20251017"}], "brand_name": "Clomiphene citrate", "product_id": "70954-825_b56e04f0-490d-4f10-a0ed-31c288f4f4c5", "dosage_form": "TABLET", "pharm_class": ["Estrogen Agonist/Antagonist [EPC]", "Selective Estrogen Receptor Modulators [MoA]"], "product_ndc": "70954-825", "generic_name": "Clomiphene citrate", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clomiphene citrate", "active_ingredients": [{"name": "CLOMIPHENE CITRATE", "strength": "50 mg/1"}], "application_number": "ANDA219781", "marketing_category": "ANDA", "marketing_start_date": "20251017", "listing_expiration_date": "20261231"}