clomiphene citrate

Generic: clomiphene citrate

Labeler: cosette pharmaceuticals nc laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clomiphene citrate
Generic Name clomiphene citrate
Labeler cosette pharmaceuticals nc laboratories, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

clomiphene citrate 50 mg/1

Manufacturer
Cosette Pharmaceuticals NC Laboratories, LLC

Identifiers & Regulatory

Product NDC 83390-107
Product ID 83390-107_3ce28083-f9f3-c59f-e063-6394a90a92e1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075528
Listing Expiration 2026-12-31
Marketing Start 2025-08-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83390107
Hyphenated Format 83390-107

Supplemental Identifiers

RxCUI
1093060
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 ANDA075528 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (83390-107-09) / 10 TABLET in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 CARTON (83390-107-30) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (2)

83390-107-09 1 BLISTER PACK in 1 CARTON (83390-107-09) / 10 TABLET in 1 BLISTER PACK 83390-107-30 3 BLISTER PACK in 1 CARTON (83390-107-30) / 10 TABLET in 1 BLISTER PACK

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": "3ce28083-f9f3-c59f-e063-6394a90a92e1", "openfda": {"unii": ["1B8447E7YI"], "rxcui": ["1093060"], "spl_set_id": ["72719958-7454-4c54-9bb4-f3054d0c5d82"], "manufacturer_name": ["Cosette Pharmaceuticals NC Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (83390-107-09)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "83390-107-09", "marketing_start_date": "20250821"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (83390-107-30)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "83390-107-30", "marketing_start_date": "20250821"}], "brand_name": "Clomiphene Citrate", "product_id": "83390-107_3ce28083-f9f3-c59f-e063-6394a90a92e1", "dosage_form": "TABLET", "pharm_class": ["Estrogen Agonist/Antagonist [EPC]", "Selective Estrogen Receptor Modulators [MoA]"], "product_ndc": "83390-107", "generic_name": "Clomiphene Citrate", "labeler_name": "Cosette Pharmaceuticals NC Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clomiphene Citrate", "active_ingredients": [{"name": "CLOMIPHENE CITRATE", "strength": "50 mg/1"}], "application_number": "ANDA075528", "marketing_category": "ANDA", "marketing_start_date": "20250821", "listing_expiration_date": "20261231"}