Home NDC 50742-389 estrogens, conjugated
Product NDC 50742-389
11-digit product format 507420389
Labeler code 50742
Product ID 50742-389_420e847b-9359-4557-be3e-8b0c8cb3203b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name estrogens, conjugated
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Ingenus Pharmaceuticals, LLC
Application ANDA214025
Marketing category ANDA
Marketing start 2025-10-16
Substance ESTROGENS, CONJUGATED
Active strength .625 mg/1
Pharmacologic classes Estrogen Receptor Agonists [MoA], Estrogen [EPC], Estrogens, Conjugated (USP) [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214025-001 CONJUGATED ESTROGENS ESTROGENS, CONJUGATED 0.3MG TABLET / ORAL AB 2025-10-15 A214025-002 CONJUGATED ESTROGENS ESTROGENS, CONJUGATED 0.45MG TABLET / ORAL AB 2025-10-15 A214025-003 CONJUGATED ESTROGENS ESTROGENS, CONJUGATED 0.625MG TABLET / ORAL AB 2025-10-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration A214025-001 CGT 2026-04-15 A214025-002 CGT 2026-04-15 A214025-003 CGT 2026-04-15
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A214025-001 CONJUGATED ESTROGENS 0.3MG TABLET / ORAL AB 2025-10-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214025-002 CONJUGATED ESTROGENS 0.45MG TABLET / ORAL AB 2025-10-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214025-003 CONJUGATED ESTROGENS 0.625MG TABLET / ORAL AB 2025-10-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214025-001 CONJUGATED ESTROGENS 0.3MG TABLET / ORAL AB 2025-10-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214025-002 CONJUGATED ESTROGENS 0.45MG TABLET / ORAL AB 2025-10-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214025-003 CONJUGATED ESTROGENS 0.625MG TABLET / ORAL AB 2025-10-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214025-001 CONJUGATED ESTROGENS 0.3MG TABLET / ORAL AB 2025-10-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214025-002 CONJUGATED ESTROGENS 0.45MG TABLET / ORAL AB 2025-10-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214025-003 CONJUGATED ESTROGENS 0.625MG TABLET / ORAL AB 2025-10-15 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214025-001 CONJUGATED ESTROGENS 0.3MG TABLET / ORAL AB 2025-10-15 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214025-002 CONJUGATED ESTROGENS 0.45MG TABLET / ORAL AB 2025-10-15 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214025-003 CONJUGATED ESTROGENS 0.625MG TABLET / ORAL AB 2025-10-15 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base estrogens, conjugated
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ESTROGENS, CONJUGATED .625 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination IU5QR144QX Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197660 Internal RxNorm lookup 310197 Internal RxNorm lookup 403849 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50742-389-01 estrogens, conjugated 100 in 1 BOTTLE TABLET, FILM COATED 100 1 50742-389-10 estrogens, conjugated 1000 in 1 BOTTLE TABLET, FILM COATED 1000 1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 50742-389-01 50742038901 100 TABLET, FILM COATED in 1 BOTTLE (50742-389-01) 2025-10-16 No No Current 50742-389-10 50742038910 1000 TABLET, FILM COATED in 1 BOTTLE (50742-389-10) 2025-10-16 No No Current