Tamoxifen Citrate

Product NDC
71335-1424
11-digit product format
713351424
Labeler code
71335
Product ID
71335-1424_62ec5985-9a78-4a17-bc82-47f1cd676935
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamoxifen Citrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206694
Marketing category
ANDA
Marketing start
2018-01-03
Marketing end
0000-00-00
Substance
TAMOXIFEN CITRATE
Active strength
20 mg/1
Pharmacologic classes
Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71335-1424DDiscontinued by firm2026-08-03
excluded packagepackage71335-142471335-1424-1DDiscontinued by firm2026-08-03
excluded packagepackage71335-142471335-1424-2DDiscontinued by firm2026-08-03
excluded packagepackage71335-142471335-1424-3DDiscontinued by firm2026-08-03
excluded packagepackage71335-142471335-1424-4DDiscontinued by firm2026-08-03
excluded packagepackage71335-142471335-1424-5DDiscontinued by firm2026-08-03
excluded packagepackage71335-142471335-1424-6DDiscontinued by firm2026-08-03

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 2 · 84 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-1424-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-1424-5d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-1424-4d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-1424-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-1424-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-1424-2d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-1424-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-1424-5f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-1424-4f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-1424-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-1424-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-1424-2f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-1424-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-1424-52ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-1424-42ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-1424-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-1424-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-1424-22ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-1424-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-1424-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-1424-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-1424-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-1424-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-1424-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-1424-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-1424-5cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-1424-4cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-1424-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-1424-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-1424-2cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-1424-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-1424-5cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-1424-4cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-1424-6cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-1424-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-1424-2cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-1424-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-1424-5302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-1424-4302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-1424-6302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-1424-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-1424-2302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-1424-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-1424-5ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-1424-4ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-1424-6ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-1424-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-1424-2ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71335-1424-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71335-1424-50efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71335-1424-40efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206694-001TAMOXIFEN CITRATETAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2017-10-27
A206694-002TAMOXIFEN CITRATETAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALAB2017-10-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A206694-001AB
A206694-002AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A206694-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2017-10-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206694-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALAB2017-10-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206694-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2017-10-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206694-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALAB2017-10-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A206694-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2017-10-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206694-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALAB2017-10-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206694-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2017-10-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206694-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALAB2017-10-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206694-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2017-10-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206694-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALAB2017-10-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206694-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2017-10-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206694-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALAB2017-10-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206694-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2017-10-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206694-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALAB2017-10-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206694-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2017-10-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206694-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALAB2017-10-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206694-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2017-10-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206694-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALAB2017-10-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206694-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2017-10-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A206694-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALAB2017-10-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206694-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2017-10-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206694-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALAB2017-10-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206694-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2017-10-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206694-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALAB2017-10-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206694-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2017-10-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206694-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALAB2017-10-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206694-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2017-10-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206694-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALAB2017-10-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206694-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2017-10-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206694-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALAB2017-10-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206694-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2017-10-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206694-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALAB2017-10-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206694-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2017-10-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206694-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALAB2017-10-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206694-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2017-10-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206694-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALAB2017-10-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206694-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2017-10-27bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206694-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALAB2017-10-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206694-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2017-10-27782e0a99824c…
2021-12-28 21:50 UTC2021-12A206694-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALAB2017-10-27782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A206694-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206694-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206694-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206694-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206694-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206694-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206694-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206694-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206694-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206694-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206694-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206694-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206694-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206694-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206694-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206694-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206694-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206694-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206694-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206694-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206694-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206694-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206694-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206694-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206694-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206694-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206694-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206694-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206694-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206694-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206694-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206694-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206694-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206694-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206694-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206694-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206694-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206694-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206694-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A206694-002AB1782e0a99824c…

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1424-17133514240130 TABLET, FILM COATED in 1 BOTTLE (71335-1424-1) 2021-12-280000-00-00NoNoCurrent
71335-1424-27133514240260 TABLET, FILM COATED in 1 BOTTLE (71335-1424-2) 2021-12-280000-00-00NoNoCurrent
71335-1424-37133514240390 TABLET, FILM COATED in 1 BOTTLE (71335-1424-3) 2019-12-030000-00-00NoNoCurrent
71335-1424-47133514240428 TABLET, FILM COATED in 1 BOTTLE (71335-1424-4) 2021-12-280000-00-00NoNoCurrent
71335-1424-57133514240558 TABLET, FILM COATED in 1 BOTTLE (71335-1424-5) 2021-12-280000-00-00NoNoCurrent
71335-1424-67133514240652 TABLET, FILM COATED in 1 BOTTLE (71335-1424-6) 2021-12-280000-00-00NoNoCurrent