Tamoxifen Citrate

Product NDC: 51862-642
11-digit product format: 518620642
Labeler code: 51862
Product ID: 51862-642_c9174e2f-4862-4934-9837-4d0a16e74753
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tamoxifen Citrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Mayne Pharma Inc.
Application: ANDA075797
Marketing category: ANDA
Marketing start: 2021-08-27
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: 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	51862-642		D	Discontinued by firm	2026-08-03
excluded package	package	51862-642	51862-642-10	D	Discontinued by firm	2026-08-03
excluded package	package	51862-642	51862-642-60	D	Discontinued by firm	2026-08-03

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 · 4 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	51862-642-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51862-642-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51862-642-10	`f5e01cc5f278…`	`a2eaf40c39c3…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075797-001	TAMOXIFEN CITRATE	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB		2003-02-20
A075797-002	TAMOXIFEN CITRATE	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2003-02-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075797-001	AB
A075797-002	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 3 · 82 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	A075797-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB		2003-02-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075797-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2003-02-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075797-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB		2003-02-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075797-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2003-02-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075797-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB		2003-02-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075797-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2003-02-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075797-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB		2003-02-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075797-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2003-02-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075797-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB		2003-02-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075797-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2003-02-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075797-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB		2003-02-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075797-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2003-02-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075797-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB		2003-02-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075797-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2003-02-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075797-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB		2003-02-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075797-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2003-02-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075797-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB		2003-02-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075797-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2003-02-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075797-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB		2003-02-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075797-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2003-02-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075797-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB		2003-02-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075797-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2003-02-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075797-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB		2003-02-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075797-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2003-02-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075797-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB		2003-02-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075797-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2003-02-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075797-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB		2003-02-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075797-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2003-02-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075797-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB		2003-02-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075797-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2003-02-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075797-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB		2003-02-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075797-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2003-02-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075797-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB		2003-02-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075797-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2003-02-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075797-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB		2003-02-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075797-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2003-02-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075797-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB		2003-02-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075797-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2003-02-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075797-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB		2003-02-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075797-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2003-02-20	`782e0a99824c…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075797-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075797-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075797-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075797-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075797-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075797-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075797-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075797-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075797-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075797-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075797-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075797-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075797-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075797-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075797-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075797-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075797-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075797-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075797-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075797-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075797-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075797-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075797-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075797-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075797-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075797-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075797-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075797-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075797-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075797-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075797-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075797-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075797-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075797-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075797-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075797-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075797-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075797-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075797-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075797-002	AB	1	`782e0a99824c…`

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
51862-642-10	Tamoxifen Citrate	1000 in 1 BOTTLE	TABLET, FILM COATED	1000		5
51862-642-60	Tamoxifen Citrate	60 in 1 BOTTLE	TABLET, FILM COATED	60		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51862-642-10	EA - Each	51862-642	e01d66a6-0fab-4576-abc2-f9c92699ddbb	1	2021-09-07
51862-642-60	EA - Each	51862-642	acdacb43-7a5d-4549-b94f-01db4b533978	1	2021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51862-642	TAMOXIFEN CITRATE TABLET, FILM COATED [MAYNE PHARMA COMMERCIAL LLC]	3	Legacy NDC, 2 package rows	20230224_c82205a3-ae0c-4ce5-b04b-9581cd8c70d4.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tamoxifen Citrate	TAMOXIFEN CITRATE	Mayne Pharma Commercial LLC	c82205a3-ae0c-4ce5-b04b-9581cd8c70d4	2025-11-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075797 application number: ANDA075797 ndc (product): 51862-642
Tamoxifen Citrate	TAMOXIFEN CITRATE	Dr. Reddy's Labratories Inc.	c6c6a643-57d6-7ea5-7da0-e8a66802468a	2024-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075797 application number: ANDA075797

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	c82205a3-ae0c-4ce5-b04b-9581cd8c70d4	5
313195	tamoxifen citrate 20 MG Oral Tablet	PSN	c82205a3-ae0c-4ce5-b04b-9581cd8c70d4	5
198240	tamoxifen 10 MG Oral Tablet	SCD	c82205a3-ae0c-4ce5-b04b-9581cd8c70d4	5
313195	tamoxifen 20 MG Oral Tablet	SCD	c82205a3-ae0c-4ce5-b04b-9581cd8c70d4	5
198240	tamoxifen 10 MG (as tamoxifen citrate 15.2 MG) Oral Tablet	SY	c82205a3-ae0c-4ce5-b04b-9581cd8c70d4	5
313195	tamoxifen 20 MG (as tamoxifen citrate 30.4 MG) Oral Tablet	SY	c82205a3-ae0c-4ce5-b04b-9581cd8c70d4	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
51862-642-10	51862064210	1000 TABLET, FILM COATED in 1 BOTTLE (51862-642-10)	2021-08-27	0000-00-00	No	No	Current
51862-642-60	51862064260	60 TABLET, FILM COATED in 1 BOTTLE (51862-642-60)	2021-08-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tamoxifen Citrate	Mayne Pharma Commercial LLC \| Catalent Greenville, Inc.	2025-11-10	HUMAN PRESCRIPTION DRUG LABEL	5
Tamoxifen Citrate	Golden State Medical Supply, Inc.	2024-12-06	HUMAN PRESCRIPTION DRUG LABEL	6
Tamoxifen Citrate	McKesson Corporation dba SKY Packaging \| Legacy Pharmaceutical Packaging, LLC	2023-10-11	HUMAN PRESCRIPTION DRUG LABEL	5