Tamoxifen Citrate

Product NDC: 68071-5254
11-digit product format: 680715254
Labeler code: 68071
Product ID: 68071-5254_1d78d7d4-4388-eab7-e063-6394a90a9e7f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tamoxifen Citrate
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA070929
Marketing category: ANDA
Marketing start: 2011-08-15
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

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
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68071-5254-3	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68071-5254-3	`bd6a592717d7…`	`303034d00443…`

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
A070929-001	TAMOXIFEN CITRATE	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB		2003-02-20
A070929-002	TAMOXIFEN CITRATE	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB		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
A070929-001	AB
A070929-002	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070929-001	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	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070929-001	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	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070929-001	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	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070929-001	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	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070929-001	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	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070929-001	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	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070929-001	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	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070929-001	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	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070929-001	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	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070929-001	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	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070929-001	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	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	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	A070929-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070929-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070929-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070929-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070929-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070929-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070929-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070929-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070929-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070929-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070929-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070929-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070929-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070929-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070929-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070929-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070929-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070929-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070929-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070929-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070929-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070929-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070929-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070929-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070929-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070929-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070929-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A070929-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070929-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070929-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070929-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A070929-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070929-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A070929-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070929-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A070929-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070929-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A070929-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070929-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A070929-002	AB	1	`782e0a99824c…`

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198240	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
a5615dbb-3c5e-6ccc-e053-2995a90ab698	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-5254-3	2022-06-09	C162847	48780-1	d6a99b39-d8db-a426-e053-dadaa90af4c2	Tamoxifen Citrate Tabs_New NDC Codes 2472 2473
68071-5254-3	2022-01-28	C162847	48780-1	d6a99b39-d8db-a426-e053-dadaa90af4c2	Tamoxifen Citrate Tabs_New NDC Codes 2472 2473

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-5254-3	Tamoxifen Citrate	30 in 1 BOTTLE	TABLET	30		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-5254	TAMOXIFEN CITRATE TABLET [NUCARE PHARMACEUTICALS,INC.]	3	Current NDC, Legacy NDC, 1 package rows	20240719_a5615dbb-3c5e-6ccc-e053-2995a90ab698.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tamoxifen Citrate	TAMOXIFEN CITRATE	Bryant Ranch Prepack	8c0eb763-420a-4106-ba56-526b53a7f72b	2026-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070929 application number: ANDA070929
Tamoxifen Citrate	TAMOXIFEN CITRATE	A-S Medication Solutions	8d731e7e-3b04-49a2-a0f6-3779422174cc	2026-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070929 application number: ANDA070929
Tamoxifen Citrate	TAMOXIFEN CITRATE	Actavis Pharma, Inc.	9b8a4211-120f-4981-ad69-928accb97637	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070929 application number: ANDA070929
Tamoxifen Citrate	TAMOXIFEN CITRATE	A-S Medication Solutions	716657e8-d809-4671-87bc-8d10ef69a071	2025-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070929 application number: ANDA070929
Tamoxifen Citrate	TAMOXIFEN CITRATE	NuCare Pharmaceuticals,Inc.	a5615dbb-3c5e-6ccc-e053-2995a90ab698	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070929 application number: ANDA070929 ndc (product): 68071-5254
Tamoxifen Citrate	TAMOXIFEN CITRATE	Proficient Rx LP	bb53eeb7-83fc-469e-b9e3-df5f27bfec7b	2022-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070929 application number: ANDA070929

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	a5615dbb-3c5e-6ccc-e053-2995a90ab698	3
198240	tamoxifen 10 MG Oral Tablet	SCD	a5615dbb-3c5e-6ccc-e053-2995a90ab698	3
198240	tamoxifen 10 MG (as tamoxifen citrate 15.2 MG) Oral Tablet	SY	a5615dbb-3c5e-6ccc-e053-2995a90ab698	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-5254-3	68071525403	30 TABLET in 1 BOTTLE (68071-5254-3)	30 tablet	2020-05-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tamoxifen Citrate Tabs_New NDC Codes 2472 2473	NuCare Pharmaceuticals,Inc.	2024-07-17	HUMAN PRESCRIPTION DRUG LABEL	3