milophene

Generic: clomiphene citrate

Labeler: burel pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name milophene
Generic Name clomiphene citrate
Labeler burel pharmaceuticals, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

clomiphene citrate 50 mg/1

Manufacturer
Burel Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 35573-470
Product ID 35573-470_a7991ccf-26b1-4ab0-bf9e-175152dccfed
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA072196
Listing Expiration 2026-12-31
Marketing Start 2025-08-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 35573470
Hyphenated Format 35573-470

Supplemental Identifiers

RxCUI
1093060 2723329
UPC
0335573470753 0335573470302
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 milophene (source: ndc)
Generic Name clomiphene citrate (source: ndc)
Application Number ANDA072196 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (35573-470-30)
  • 10 TABLET in 1 BOTTLE (35573-470-75)
source: ndc

Packages (2)

35573-470-30 30 TABLET in 1 BOTTLE (35573-470-30) 35573-470-75 10 TABLET in 1 BOTTLE (35573-470-75)

Ingredients (1)

clomiphene citrate (50 mg/1)

Linked Drug Pages (1)

MiloPhene ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a7991ccf-26b1-4ab0-bf9e-175152dccfed", "openfda": {"upc": ["0335573470753", "0335573470302"], "unii": ["1B8447E7YI"], "rxcui": ["1093060", "2723329"], "spl_set_id": ["b56131e5-efc7-43af-ac13-4a2ae918df4e"], "manufacturer_name": ["Burel Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (35573-470-30)", "package_ndc": "35573-470-30", "marketing_start_date": "20250815"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE (35573-470-75)", "package_ndc": "35573-470-75", "marketing_start_date": "20251201"}], "brand_name": "MiloPhene", "product_id": "35573-470_a7991ccf-26b1-4ab0-bf9e-175152dccfed", "dosage_form": "TABLET", "pharm_class": ["Estrogen Agonist/Antagonist [EPC]", "Selective Estrogen Receptor Modulators [MoA]"], "product_ndc": "35573-470", "generic_name": "Clomiphene Citrate", "labeler_name": "Burel Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MiloPhene", "active_ingredients": [{"name": "CLOMIPHENE CITRATE", "strength": "50 mg/1"}], "application_number": "ANDA072196", "marketing_category": "ANDA", "marketing_start_date": "20250815", "listing_expiration_date": "20261231"}