Home NDC 66993-295 Conjugated Estrogens
Product NDC 66993-295
11-digit product format 669930295
Labeler code 66993
Product ID 66993-295_ce793f9e-0c20-43e6-9dc0-064e5c82e243
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name estrogens, conjugated
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Prasco Laboratories
Application NDA004782
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2026-02-27
Substance ESTROGENS, CONJUGATED
Active strength .3 mg/1
Pharmacologic classes Estrogen Receptor Agonists [MoA], Estrogen [EPC], Estrogens, Conjugated (USP) [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N004782-001 PREMARIN ESTROGENS, CONJUGATED 1.25MG TABLET / ORAL AB RLD, RS, Approved before 1982 N004782-002 PREMARIN ESTROGENS, CONJUGATED 2.5MG TABLET / ORAL Approved before 1982 N004782-003 PREMARIN ESTROGENS, CONJUGATED 0.3MG TABLET / ORAL AB RLD, Approved before 1982 N004782-004 PREMARIN ESTROGENS, CONJUGATED 0.625MG TABLET / ORAL AB RLD, RS, Approved before 1982 N004782-005 PREMARIN ESTROGENS, CONJUGATED 0.9MG TABLET / ORAL AB RLD, RS 1984-01-26 N004782-006 PREMARIN ESTROGENS, CONJUGATED 0.45MG TABLET / ORAL AB RLD 2003-07-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 matching rows.
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 2026-08-01 22:54:32 2026-06 N004782-001 PREMARIN 1.25MG TABLET / ORAL AB RLD, RS, Approved before 1982 a50c72e98297…2026-08-01 22:54:32 2026-06 N004782-002 PREMARIN 2.5MG TABLET / ORAL Approved before 1982 a50c72e98297…2026-08-01 22:54:32 2026-06 N004782-003 PREMARIN 0.3MG TABLET / ORAL AB RLD, Approved before 1982 a50c72e98297…2026-08-01 22:54:32 2026-06 N004782-004 PREMARIN 0.625MG TABLET / ORAL AB RLD, RS, Approved before 1982 a50c72e98297…2026-08-01 22:54:32 2026-06 N004782-005 PREMARIN 0.9MG TABLET / ORAL AB RLD, RS 1984-01-26 a50c72e98297…2026-08-01 22:54:32 2026-06 N004782-006 PREMARIN 0.45MG TABLET / ORAL AB RLD 2003-07-16 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Premarin ESTROGENS, CONJUGATED Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 258e1602-a3cf-4ccc-ca80-73dbbfb812ff 2026-06-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 004782 application number: NDA004782 Conjugated Estrogens ESTROGENS, CONJUGATED Prasco Laboratories ce793f9e-0c20-43e6-9dc0-064e5c82e243 2026-02-27 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 004782 application number: NDA004782 ndc (product): 66993-295 Premarin ESTROGENS, CONJUGATED A-S Medication Solutions a3b86b85-8923-42ae-aa31-a66a6e090327 2025-04-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 004782 application number: NDA004782 PREMARIN ESTROGENS, CONJUGATED A-S Medication Solutions 2b4dbb7c-4e6d-47c9-b940-fef91f1f4a05 2024-02-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 004782 application number: NDA004782
Additional Listing Data#
Finished product Yes
Brand name base Conjugated Estrogens
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ESTROGENS, CONJUGATED .3 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 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197660 Internal RxNorm lookup 197661 Internal RxNorm lookup 197662 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 66993-295-02 Conjugated Estrogens 100 in 1 BOTTLE TABLET, FILM COATED 100 1
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 197660 estrogens, conjugated 0.3 MG Oral Tablet PSN ce793f9e-0c20-43e6-9dc0-064e5c82e243 1 403849 estrogens, conjugated 0.45 MG Oral Tablet PSN ce793f9e-0c20-43e6-9dc0-064e5c82e243 1 310197 estrogens, conjugated 0.625 MG Oral Tablet PSN ce793f9e-0c20-43e6-9dc0-064e5c82e243 1 197661 estrogens, conjugated 0.9 MG Oral Tablet PSN ce793f9e-0c20-43e6-9dc0-064e5c82e243 1 197662 estrogens, conjugated 1.25 MG Oral Tablet PSN ce793f9e-0c20-43e6-9dc0-064e5c82e243 1 197660 estrogens, conjugated (USP) 0.3 MG Oral Tablet SCD ce793f9e-0c20-43e6-9dc0-064e5c82e243 1 403849 estrogens, conjugated (USP) 0.45 MG Oral Tablet SCD ce793f9e-0c20-43e6-9dc0-064e5c82e243 1 310197 estrogens, conjugated (USP) 0.625 MG Oral Tablet SCD ce793f9e-0c20-43e6-9dc0-064e5c82e243 1 197661 estrogens, conjugated (USP) 0.9 MG Oral Tablet SCD ce793f9e-0c20-43e6-9dc0-064e5c82e243 1 197662 estrogens, conjugated (USP) 1.25 MG Oral Tablet SCD ce793f9e-0c20-43e6-9dc0-064e5c82e243 1 310197 estrogens, conjugated (USP) 625 MCG Oral Tablet SY ce793f9e-0c20-43e6-9dc0-064e5c82e243 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 66993-295-02 66993029502 100 TABLET, FILM COATED in 1 BOTTLE (66993-295-02) 2026-02-27 No No Current