Tamoxifen Citrate

Product NDC: 59651-299
Requested package NDC: 59651-299-60
11-digit product format: 596510299
Labeler code: 59651
Product ID: 59651-299_a596c715-8e30-43c1-aba3-4fe5de6729fa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tamoxifen Citrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA213358
Marketing category: ANDA
Marketing start: 2020-08-14
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213358-001	TAMOXIFEN CITRATE	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB		2020-08-14
A213358-002	TAMOXIFEN CITRATE	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB		2020-08-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213358-001	AB
A213358-002	AB

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 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A213358-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213358-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213358-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213358-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213358-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213358-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213358-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213358-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213358-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213358-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213358-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213358-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213358-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213358-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213358-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213358-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213358-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213358-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213358-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213358-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213358-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213358-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213358-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213358-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213358-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213358-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213358-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213358-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213358-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213358-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213358-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213358-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213358-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213358-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213358-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213358-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213358-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213358-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-14	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213358-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213358-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-14	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A213358-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213358-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213358-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213358-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213358-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213358-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213358-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213358-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213358-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213358-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213358-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213358-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213358-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213358-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213358-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213358-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213358-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213358-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213358-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213358-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213358-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213358-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213358-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213358-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213358-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213358-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213358-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213358-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213358-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213358-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213358-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213358-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213358-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213358-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213358-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213358-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213358-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213358-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213358-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213358-002	AB	1	`bb7c543d1eb4…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TAMOXIFEN CITRATE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7FRV7310N6	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
a596c715-8e30-43c1-aba3-4fe5de6729fa	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c3572c17-50b0-db2d-1012-2cc228ccf88f	Product name	3	20201015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59651-299-60	Tamoxifen Citrate	60 in 1 BOTTLE	TABLET, FILM COATED	60		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59651-299-60	EA - Each	59651-299	3770b94a-2713-4432-a3ce-d5ada818798c	1	2021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59651-299	TAMOXIFEN CITRATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	1	Current NDC, Legacy NDC, 1 package rows	20200821_a596c715-8e30-43c1-aba3-4fe5de6729fa.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
Tamoxifen Citrate	TAMOXIFEN CITRATE	NuCare Pharmaceuticals, Inc.	509f8ba3-214d-aec8-e063-6294a90af498	2026-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213358 application number: ANDA213358
Tamoxifen Citrate	TAMOXIFEN CITRATE	Bryant Ranch Prepack	9b4a8abc-6e56-40c5-a826-1d1f3c0786e1	2024-11-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213358 application number: ANDA213358
Tamoxifen Citrate	TAMOXIFEN CITRATE	Bryant Ranch Prepack	feb96056-79f5-4024-ab0e-fdbb8d4ab862	2024-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213358 application number: ANDA213358
Tamoxifen Citrate	TAMOXIFEN CITRATE	Aurobindo Pharma Limited	a596c715-8e30-43c1-aba3-4fe5de6729fa	2020-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213358 application number: ANDA213358 ndc (package): 59651-299-60 ndc (product): 59651-299 ndc11 (package): 59651029960

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7FRV7310N6	TAMOXIFEN CITRATE	54965-24-1	TAMOXIFEN CITRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198240	tamoxifen citrate 10 MG Oral Tablet	PSN	feb96056-79f5-4024-ab0e-fdbb8d4ab862	101
198240	tamoxifen 10 MG Oral Tablet	SCD	feb96056-79f5-4024-ab0e-fdbb8d4ab862	101
198240	tamoxifen 10 MG (as tamoxifen citrate 15.2 MG) Oral Tablet	SY	feb96056-79f5-4024-ab0e-fdbb8d4ab862	101
198240	tamoxifen citrate 10 MG Oral Tablet	PSN	509f8ba3-214d-aec8-e063-6294a90af498	2
198240	tamoxifen 10 MG Oral Tablet	SCD	509f8ba3-214d-aec8-e063-6294a90af498	2
198240	tamoxifen 10 MG (as tamoxifen citrate 15.2 MG) Oral Tablet	SY	509f8ba3-214d-aec8-e063-6294a90af498	2
198240	tamoxifen citrate 10 MG Oral Tablet	PSN	04037219-48aa-ca18-e063-6394a90abc29	1
198240	tamoxifen citrate 10 MG Oral Tablet	PSN	a596c715-8e30-43c1-aba3-4fe5de6729fa	1
313195	tamoxifen citrate 20 MG Oral Tablet	PSN	a596c715-8e30-43c1-aba3-4fe5de6729fa	1
198240	tamoxifen 10 MG Oral Tablet	SCD	04037219-48aa-ca18-e063-6394a90abc29	1
198240	tamoxifen 10 MG Oral Tablet	SCD	a596c715-8e30-43c1-aba3-4fe5de6729fa	1
313195	tamoxifen 20 MG Oral Tablet	SCD	a596c715-8e30-43c1-aba3-4fe5de6729fa	1
198240	tamoxifen 10 MG (as tamoxifen citrate 15.2 MG) Oral Tablet	SY	04037219-48aa-ca18-e063-6394a90abc29	1
198240	tamoxifen 10 MG (as tamoxifen citrate 15.2 MG) Oral Tablet	SY	a596c715-8e30-43c1-aba3-4fe5de6729fa	1
313195	tamoxifen 20 MG (as tamoxifen citrate 30.4 MG) Oral Tablet	SY	a596c715-8e30-43c1-aba3-4fe5de6729fa	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
59651-299-60	59651029960	60 TABLET, FILM COATED in 1 BOTTLE (59651-299-60)	2020-08-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tamoxifen Citrate Tablets, USP Rx Only	NuCare Pharmaceuticals, Inc.	2026-04-30	HUMAN PRESCRIPTION DRUG LABEL	2
Tamoxifen Citrate Tablets, USP Rx Only	Bryant Ranch Prepack	2024-01-19	HUMAN PRESCRIPTION DRUG LABEL	101
Tamoxifen Citrate Tablets, USP Rx Only	NuCare Pharmaceuticals,Inc.	2023-08-28	HUMAN PRESCRIPTION DRUG LABEL	1
Tamoxifen Citrate Tablets, USP Rx Only	Aurobindo Pharma Limited \| EUGIA Pharma Specialities Limited	2020-08-14	Human Prescription Drug Label	1