Home NDC 43353-687 Premarin
Product NDC 43353-687
11-digit product format 433530687
Labeler code 43353
Product ID 43353-687_950b1a7a-07f6-4741-9846-0e2f7e798e3e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name conjugated estrogens
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, Inc.
Application NDA004782
Marketing category NDA
Marketing start 2006-01-01
Marketing end 0000-00-00
Substance ESTROGENS, CONJUGATED
Active strength 0 mg/1
Pharmacologic classes Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [CS]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 43353-687-60 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 43353-687-60 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 43353-687-60 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 43353-687-60 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 43353-687-60 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 43353-687-60 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 43353-687-60 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 43353-687-60 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 43353-687-60 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 43353-687-60 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 43353-687-60 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 43353-687-60 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 43353-687-60 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 43353-687-60 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 43353-687-60 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 43353-687-60 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 43353-687-60 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 43353-687-60 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 43353-687-60 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 43353-687-60 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 43353-687-60 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 43353-687-60 110d247fa046…a55b01930146…
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# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43353-687-60 Premarin 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ESTROGENS, CONJUGATED ACTIVE INGREDIENT IU5QR144QX PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 ESTROGENS, CONJUGATED ACTIVE MOIETY IU5QR144QX PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 HYPROMELLOSE 2208 (15000 MPA.S) INACTIVE INGREDIENT Z78RG6M2N2 PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 HYPROMELLOSE 2910 (15 MPA.S) INACTIVE INGREDIENT 36SFW2JZ0W PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 POWDERED CELLULOSE INACTIVE INGREDIENT SMD1X3XO9M PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 TRIBASIC CALCIUM PHOSPHATE INACTIVE INGREDIENT 91D9GV0Z28 PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-687 PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 Legacy NDC, 1 package rows 20120813_751b6213-92d8-40f8-a2d5-83e8dad086dd.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 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 Status 43353-687-60 43353068760 90 in 1 BOTTLE, PLASTIC Historical