estrogens, conjugated

Generic: estrogens, conjugated

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

Drug Facts

Product Profile

Brand Name estrogens, conjugated
Generic Name estrogens, conjugated
Labeler ingenus pharmaceuticals, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

estrogens, conjugated .625 mg/1

Manufacturer
Ingenus Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 50742-389
Product ID 50742-389_420e847b-9359-4557-be3e-8b0c8cb3203b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214025
Listing Expiration 2026-12-31
Marketing Start 2025-10-16

Pharmacologic Class

Established (EPC)
estrogen [epc]
Mechanism of Action
estrogen receptor agonists [moa]
Chemical Structure
estrogens, conjugated (usp) [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50742389
Hyphenated Format 50742-389

Supplemental Identifiers

RxCUI
197660 310197 403849
UPC
0350742387014 0350742389018 0350742388011
UNII
IU5QR144QX
NUI
N0000175825 N0000000100 M0007792

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 estrogens, conjugated (source: ndc)
Generic Name estrogens, conjugated (source: ndc)
Application Number ANDA214025 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .625 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (50742-389-01)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (50742-389-10)
source: ndc

Packages (2)

50742-389-01 100 TABLET, FILM COATED in 1 BOTTLE (50742-389-01) 50742-389-10 1000 TABLET, FILM COATED in 1 BOTTLE (50742-389-10)

Ingredients (1)

estrogens, conjugated (.625 mg/1)

Linked Drug Pages (1)

estrogens, conjugated ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "420e847b-9359-4557-be3e-8b0c8cb3203b", "openfda": {"nui": ["N0000175825", "N0000000100", "M0007792"], "upc": ["0350742387014", "0350742389018", "0350742388011"], "unii": ["IU5QR144QX"], "rxcui": ["197660", "310197", "403849"], "spl_set_id": ["b17eca23-f387-4243-a76a-bcf6b88aeef9"], "pharm_class_cs": ["Estrogens, Conjugated (USP) [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Ingenus Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (50742-389-01)", "package_ndc": "50742-389-01", "marketing_start_date": "20251016"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (50742-389-10)", "package_ndc": "50742-389-10", "marketing_start_date": "20251016"}], "brand_name": "estrogens, conjugated", "product_id": "50742-389_420e847b-9359-4557-be3e-8b0c8cb3203b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Estrogens", "Conjugated (USP) [CS]"], "product_ndc": "50742-389", "generic_name": "estrogens, conjugated", "labeler_name": "Ingenus Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "estrogens, conjugated", "active_ingredients": [{"name": "ESTROGENS, CONJUGATED", "strength": ".625 mg/1"}], "application_number": "ANDA214025", "marketing_category": "ANDA", "marketing_start_date": "20251016", "listing_expiration_date": "20261231"}