Tamoxifen Citrate

Product NDC
0591-2473
11-digit product format
005912473
Labeler code
0591
Product ID
0591-2473_20254a14-2e07-4279-8263-c63b6a71d861
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamoxifen Citrate
Dosage form
TABLET
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA070929
Marketing category
ANDA
Marketing start
2011-08-15
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
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A070929-001TAMOXIFEN CITRATETAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2003-02-20
A070929-002TAMOXIFEN CITRATETAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALAB2003-02-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A070929-001AB
A070929-002AB

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 UTC2026-02A070929-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2003-02-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070929-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALAB2003-02-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070929-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2003-02-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070929-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALAB2003-02-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A070929-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2003-02-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070929-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALAB2003-02-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070929-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2003-02-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070929-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALAB2003-02-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070929-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2003-02-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070929-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALAB2003-02-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070929-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2003-02-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070929-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALAB2003-02-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070929-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2003-02-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070929-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALAB2003-02-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070929-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2003-02-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070929-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALAB2003-02-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070929-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2003-02-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070929-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALAB2003-02-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070929-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2003-02-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A070929-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALAB2003-02-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070929-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2003-02-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070929-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALAB2003-02-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070929-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2003-02-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070929-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALAB2003-02-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070929-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2003-02-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070929-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALAB2003-02-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070929-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2003-02-208072bd15b7f6…
2024-05-31 18:47 UTC2024-05A070929-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALAB2003-02-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070929-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2003-02-205c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070929-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALAB2003-02-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070929-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2003-02-205d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A070929-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALAB2003-02-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070929-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2003-02-204b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A070929-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALAB2003-02-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070929-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2003-02-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A070929-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALAB2003-02-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070929-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2003-02-20bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A070929-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALAB2003-02-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070929-001TAMOXIFEN CITRATEEQ 10MG BASETABLET / ORALAB2003-02-20782e0a99824c…
2021-12-28 21:50 UTC2021-12A070929-002TAMOXIFEN CITRATEEQ 20MG BASETABLET / ORALAB2003-02-20782e0a99824c…

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 UTC2026-02A070929-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070929-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070929-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070929-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A070929-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070929-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070929-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070929-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070929-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070929-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070929-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070929-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070929-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070929-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070929-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070929-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070929-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070929-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070929-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A070929-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070929-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070929-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070929-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070929-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070929-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070929-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070929-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A070929-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070929-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070929-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070929-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A070929-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070929-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A070929-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070929-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A070929-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070929-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A070929-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070929-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A070929-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Tamoxifen Citrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TAMOXIFEN CITRATE20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7FRV7310N6Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198240Internal RxNorm lookup
313195Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9b8a4211-120f-4981-ad69-928accb97637Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-2473-19Tamoxifen Citrate90 in 1 BOTTLE, PLASTICTABLET908
0591-2473-30Tamoxifen Citrate30 in 1 BOTTLE, PLASTICTABLET308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-2473-19EA - Each0591-24735681c988-d079-408d-9824-ec998c31c4b012012-07-24
0591-2473-30EA - Each0591-2473eaf74f22-4181-4d98-a26a-438bd48028d512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TAMOXIFEN CITRATEACTIVE INGREDIENT7FRV7310N6TAMOXIFEN CITRATE TABLET [WATSON LABORATORIES, INC.]1
TAMOXIFENACTIVE MOIETY094ZI81Y45TAMOXIFEN CITRATE TABLET [WATSON LABORATORIES, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTAMOXIFEN CITRATE TABLET [WATSON LABORATORIES, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48TAMOXIFEN CITRATE TABLET [WATSON LABORATORIES, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTAMOXIFEN CITRATE TABLET [WATSON LABORATORIES, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TAMOXIFEN CITRATE TABLET [WATSON LABORATORIES, INC.]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJTAMOXIFEN CITRATE TABLET [WATSON LABORATORIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-2473TAMOXIFEN CITRATE TABLET [ACTAVIS PHARMA, INC.]6Current NDC, Legacy NDC, 2 package rows20220326_9b8a4211-120f-4981-ad69-928accb97637.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tamoxifen CitrateTAMOXIFEN CITRATEBryant Ranch Prepack8c0eb763-420a-4106-ba56-526b53a7f72b2026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070929
application number: ANDA070929
Tamoxifen CitrateTAMOXIFEN CITRATEA-S Medication Solutions8d731e7e-3b04-49a2-a0f6-3779422174cc2026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070929
application number: ANDA070929
Tamoxifen CitrateTAMOXIFEN CITRATEActavis Pharma, Inc.9b8a4211-120f-4981-ad69-928accb976372025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070929
application number: ANDA070929
ndc (product): 0591-2473
Tamoxifen CitrateTAMOXIFEN CITRATEA-S Medication Solutions716657e8-d809-4671-87bc-8d10ef69a0712025-11-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070929
application number: ANDA070929
Tamoxifen CitrateTAMOXIFEN CITRATENuCare Pharmaceuticals,Inc.a5615dbb-3c5e-6ccc-e053-2995a90ab6982024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070929
application number: ANDA070929
Tamoxifen CitrateTAMOXIFEN CITRATEProficient Rx LPbb53eeb7-83fc-469e-b9e3-df5f27bfec7b2022-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070929
application number: ANDA070929

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313195tamoxifen citrate 20 MG Oral TabletPSN716657e8-d809-4671-87bc-8d10ef69a07116
313195tamoxifen 20 MG Oral TabletSCD716657e8-d809-4671-87bc-8d10ef69a07116
313195tamoxifen 20 MG (as tamoxifen citrate 30.4 MG) Oral TabletSY716657e8-d809-4671-87bc-8d10ef69a07116
198240tamoxifen citrate 10 MG Oral TabletPSN9b8a4211-120f-4981-ad69-928accb976378
313195tamoxifen citrate 20 MG Oral TabletPSN9b8a4211-120f-4981-ad69-928accb976378
198240tamoxifen 10 MG Oral TabletSCD9b8a4211-120f-4981-ad69-928accb976378
313195tamoxifen 20 MG Oral TabletSCD9b8a4211-120f-4981-ad69-928accb976378
198240tamoxifen 10 MG (as tamoxifen citrate 15.2 MG) Oral TabletSY9b8a4211-120f-4981-ad69-928accb976378
313195tamoxifen 20 MG (as tamoxifen citrate 30.4 MG) Oral TabletSY9b8a4211-120f-4981-ad69-928accb976378
313195tamoxifen citrate 20 MG Oral TabletPSNbb53eeb7-83fc-469e-b9e3-df5f27bfec7b5
313195tamoxifen 20 MG Oral TabletSCDbb53eeb7-83fc-469e-b9e3-df5f27bfec7b5
313195tamoxifen 20 MG (as tamoxifen citrate 30.4 MG) Oral TabletSYbb53eeb7-83fc-469e-b9e3-df5f27bfec7b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-2473-190059124731990 TABLET in 1 BOTTLE, PLASTIC (0591-2473-19) 90 tablet2011-08-150000-00-00NoNoCurrent
0591-2473-300059124733030 TABLET in 1 BOTTLE, PLASTIC (0591-2473-30) 30 tablet2011-08-150000-00-00NoNoCurrent