Home NDC 50090-0167 Premarin
Product NDC 50090-0167
11-digit product format 500900167
Labeler code 50090
Product ID 50090-0167_3438144a-8319-4971-981b-38f13201b980
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name estrogens, conjugated
Dosage form TABLET, FILM COATED
Route ORAL
Labeler A-S Medication Solutions
Application NDA004782
Marketing category NDA
Marketing start 2006-01-01
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 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.
Product history page 1 of 7 · 246 observed 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 2026-02-19 14:30 UTC 2026-02 N004782-001 PREMARIN 1.25MG TABLET / ORAL AB RLD, RS, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N004782-002 PREMARIN 2.5MG TABLET / ORAL Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N004782-003 PREMARIN 0.3MG TABLET / ORAL AB RLD, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N004782-004 PREMARIN 0.625MG TABLET / ORAL AB RLD, RS, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N004782-005 PREMARIN 0.9MG TABLET / ORAL AB RLD, RS 1984-01-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N004782-006 PREMARIN 0.45MG TABLET / ORAL AB RLD 2003-07-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N004782-001 PREMARIN 1.25MG TABLET / ORAL AB RLD, RS, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N004782-002 PREMARIN 2.5MG TABLET / ORAL Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N004782-003 PREMARIN 0.3MG TABLET / ORAL AB RLD, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N004782-004 PREMARIN 0.625MG TABLET / ORAL AB RLD, RS, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N004782-005 PREMARIN 0.9MG TABLET / ORAL AB RLD, RS 1984-01-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N004782-006 PREMARIN 0.45MG TABLET / ORAL AB RLD 2003-07-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N004782-001 PREMARIN 1.25MG TABLET / ORAL RLD, RS, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N004782-002 PREMARIN 2.5MG TABLET / ORAL Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N004782-003 PREMARIN 0.3MG TABLET / ORAL RLD, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N004782-004 PREMARIN 0.625MG TABLET / ORAL RLD, RS, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N004782-005 PREMARIN 0.9MG TABLET / ORAL RLD, RS 1984-01-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N004782-006 PREMARIN 0.45MG TABLET / ORAL RLD 2003-07-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N004782-001 PREMARIN 1.25MG TABLET / ORAL RLD, RS, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N004782-002 PREMARIN 2.5MG TABLET / ORAL Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N004782-003 PREMARIN 0.3MG TABLET / ORAL RLD, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N004782-004 PREMARIN 0.625MG TABLET / ORAL RLD, RS, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N004782-005 PREMARIN 0.9MG TABLET / ORAL RLD, RS 1984-01-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N004782-006 PREMARIN 0.45MG TABLET / ORAL RLD 2003-07-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N004782-001 PREMARIN 1.25MG TABLET / ORAL RLD, RS, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N004782-002 PREMARIN 2.5MG TABLET / ORAL Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N004782-003 PREMARIN 0.3MG TABLET / ORAL RLD, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N004782-004 PREMARIN 0.625MG TABLET / ORAL RLD, RS, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N004782-005 PREMARIN 0.9MG TABLET / ORAL RLD, RS 1984-01-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N004782-006 PREMARIN 0.45MG TABLET / ORAL RLD 2003-07-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N004782-001 PREMARIN 1.25MG TABLET / ORAL RLD, RS, Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N004782-002 PREMARIN 2.5MG TABLET / ORAL Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N004782-003 PREMARIN 0.3MG TABLET / ORAL RLD, Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N004782-004 PREMARIN 0.625MG TABLET / ORAL RLD, RS, Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N004782-005 PREMARIN 0.9MG TABLET / ORAL RLD, RS 1984-01-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N004782-006 PREMARIN 0.45MG TABLET / ORAL RLD 2003-07-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N004782-001 PREMARIN 1.25MG TABLET / ORAL RLD, RS, Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N004782-002 PREMARIN 2.5MG TABLET / ORAL Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N004782-003 PREMARIN 0.3MG TABLET / ORAL RLD, Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N004782-004 PREMARIN 0.625MG TABLET / ORAL RLD, RS, Approved before 1982 2680178bc6a6…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Premarin
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 150840 Internal RxNorm lookup 310197 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 50090-0167-0 Premarin 100 in 1 BOTTLE TABLET, FILM COATED 100 23 50090-0167-5 Premarin 30 in 1 BOTTLE TABLET, FILM COATED 30 23
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-0167 PREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] 23 Current NDC, Legacy NDC, 2 package rows 20250406_a3b86b85-8923-42ae-aa31-a66a6e090327.zip
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 · 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 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 ndc (product): 50090-0167 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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 50090-0167-0 50090016700 100 TABLET, FILM COATED in 1 BOTTLE (50090-0167-0) 2018-10-29 0000-00-00 No No Current 50090-0167-5 50090016705 30 TABLET, FILM COATED in 1 BOTTLE (50090-0167-5) 2016-06-21 0000-00-00 No No Current