clomiphene citrate

Generic: clomiphene citrtae

Labeler: appco pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clomiphene citrate
Generic Name clomiphene citrtae
Labeler appco pharma llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

clomiphene citrate 50 mg/1

Manufacturer
Appco Pharma LLC

Identifiers & Regulatory

Product NDC 55801-187
Product ID 55801-187_b22cc371-c969-4446-8cba-32a7e469ae80
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216739
Listing Expiration 2026-12-31
Marketing Start 2024-11-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55801187
Hyphenated Format 55801-187

Supplemental Identifiers

RxCUI
1093060
UPC
0364980690034
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 citrtae (source: ndc)
Application Number ANDA216739 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (55801-187-01)
source: ndc

Packages (1)

55801-187-01 30 TABLET in 1 BOTTLE (55801-187-01)

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": "b22cc371-c969-4446-8cba-32a7e469ae80", "openfda": {"upc": ["0364980690034"], "unii": ["1B8447E7YI"], "rxcui": ["1093060"], "spl_set_id": ["2d257ec2-827c-4bc2-8f17-cf24520c3cad"], "manufacturer_name": ["Appco Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (55801-187-01)", "package_ndc": "55801-187-01", "marketing_start_date": "20241118"}], "brand_name": "Clomiphene Citrate", "product_id": "55801-187_b22cc371-c969-4446-8cba-32a7e469ae80", "dosage_form": "TABLET", "pharm_class": ["Estrogen Agonist/Antagonist [EPC]", "Selective Estrogen Receptor Modulators [MoA]"], "product_ndc": "55801-187", "generic_name": "Clomiphene Citrtae", "labeler_name": "Appco Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clomiphene Citrate", "active_ingredients": [{"name": "CLOMIPHENE CITRATE", "strength": "50 mg/1"}], "application_number": "ANDA216739", "marketing_category": "ANDA", "marketing_start_date": "20241118", "listing_expiration_date": "20261231"}