Tamoxifen Citrate

Product NDC
63739-269
Requested package NDC
63739-269-10
11-digit product format
637390269
Labeler code
63739
Product ID
63739-269_b944fc3d-fdde-af43-e053-2a95a90a2ea8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamoxifen Citrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
McKesson Corporation dba SKY Packaging
Application
ANDA075797
Marketing category
ANDA
Marketing start
2003-02-20
Marketing end
0000-00-00
Substance
TAMOXIFEN CITRATE
Active strength
10 mg/1
Pharmacologic classes
Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63739-26963739-269-10IInactivated by FDA2026-08-03

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 1 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
A075797-001TAMOXIFEN CITRATETAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2003-02-20
A075797-002TAMOXIFEN CITRATETAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALABRS2003-02-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075797-001AB
A075797-002AB

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 UTC2026-02A075797-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2003-02-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075797-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALABRS2003-02-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075797-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2003-02-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075797-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALABRS2003-02-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A075797-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2003-02-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075797-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALABRS2003-02-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075797-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2003-02-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075797-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALABRS2003-02-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075797-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2003-02-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075797-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALABRS2003-02-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075797-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2003-02-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075797-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALABRS2003-02-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075797-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2003-02-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075797-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALABRS2003-02-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075797-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2003-02-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075797-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALABRS2003-02-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075797-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2003-02-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075797-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALABRS2003-02-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075797-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2003-02-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A075797-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALABRS2003-02-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075797-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2003-02-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075797-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALABRS2003-02-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075797-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2003-02-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075797-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALABRS2003-02-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075797-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2003-02-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075797-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALABRS2003-02-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075797-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2003-02-208072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075797-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALABRS2003-02-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075797-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2003-02-205c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075797-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALABRS2003-02-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075797-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2003-02-205d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075797-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALABRS2003-02-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075797-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2003-02-204b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075797-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALABRS2003-02-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075797-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2003-02-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075797-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALABRS2003-02-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075797-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2003-02-20bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075797-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALABRS2003-02-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075797-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2003-02-20782e0a99824c…
2021-12-28 21:50 UTC2021-12A075797-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALABRS2003-02-20782e0a99824c…

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 UTC2026-02A075797-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075797-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075797-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075797-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075797-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075797-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075797-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075797-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075797-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075797-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075797-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075797-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075797-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075797-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075797-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075797-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075797-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075797-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075797-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075797-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075797-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075797-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075797-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075797-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075797-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075797-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075797-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075797-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075797-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075797-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075797-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075797-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075797-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075797-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075797-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075797-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075797-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075797-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075797-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A075797-002AB1782e0a99824c…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c3572c17-50b0-db2d-1012-2cc228ccf88fProduct name320201015

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63739-269-10Tamoxifen Citrate10 in 1 BLISTER PACKTABLET, FILM COATED1011
63739-269-10Tamoxifen Citrate10 in 1 BOX, UNIT-DOSETABLET, FILM COATED1011
63739-269-42Tamoxifen Citrate60 in 1 BOTTLETABLET, FILM COATED6011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-269-10EA - Each63739-2690b50f78d-c8bc-470e-854e-ddafc4f9321d12012-07-24
63739-269-42EA - Each63739-2690d471273-61a4-43b9-9c14-c19e1997ec0d12019-06-19

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63739-269TAMOXIFEN CITRATE TABLET, FILM COATED [MCKESSON CORPORATION DBA SKY PACKAGING]11Legacy NDC, 3 package rows20210120_151ce76c-2d44-4c82-850d-ab213bea4d6b.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tamoxifen CitrateTAMOXIFEN CITRATEMayne Pharma Commercial LLCc82205a3-ae0c-4ce5-b04b-9581cd8c70d42025-11-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075797
application number: ANDA075797
Tamoxifen CitrateTAMOXIFEN CITRATEDr. Reddy's Labratories Inc.c6c6a643-57d6-7ea5-7da0-e8a66802468a2024-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075797
application number: ANDA075797

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198240tamoxifen citrate 10 MG Oral TabletPSN151ce76c-2d44-4c82-850d-ab213bea4d6b11
198240tamoxifen 10 MG Oral TabletSCD151ce76c-2d44-4c82-850d-ab213bea4d6b11
198240tamoxifen 10 MG (as tamoxifen citrate 15.2 MG) Oral TabletSY151ce76c-2d44-4c82-850d-ab213bea4d6b11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63739-269-106373902691010 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-269-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2003-02-200000-00-00NoNoCurrent