Tamoxifen Citrate

Product NDC: 68382-827
11-digit product format: 683820827
Labeler code: 68382
Product ID: 68382-827_3c910886-2c1b-4da0-944d-c7064b571d24
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tamoxifen Citrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Zydus Pharmaceuticals USA Inc.
Application: ANDA206694
Marketing category: ANDA
Marketing start: 2018-01-03
Marketing end: 0000-00-00
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: 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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68382-827		D	Discontinued by firm	2026-08-03
excluded package	package	68382-827	68382-827-01	D	Discontinued by firm	2026-08-03
excluded package	package	68382-827	68382-827-06	D	Discontinued by firm	2026-08-03
excluded package	package	68382-827	68382-827-10	D	Discontinued by firm	2026-08-03
excluded package	package	68382-827	68382-827-14	D	Discontinued by firm	2026-08-03
excluded package	package	68382-827	68382-827-16	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 · 12 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	68382-827-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68382-827-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68382-827-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68382-827-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68382-827-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68382-827-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68382-827-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68382-827-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68382-827-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68382-827-06	`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
A206694-001	TAMOXIFEN CITRATE	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB		2017-10-27
A206694-002	TAMOXIFEN CITRATE	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB		2017-10-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206694-001	AB
A206694-002	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	A206694-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206694-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2017-10-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206694-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206694-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2017-10-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206694-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206694-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2017-10-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206694-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206694-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2017-10-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206694-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206694-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2017-10-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206694-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206694-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2017-10-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206694-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206694-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2017-10-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206694-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206694-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2017-10-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206694-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206694-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2017-10-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206694-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206694-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2017-10-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206694-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206694-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2017-10-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206694-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206694-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2017-10-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206694-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206694-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2017-10-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206694-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206694-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2017-10-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206694-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206694-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2017-10-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206694-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206694-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2017-10-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206694-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206694-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2017-10-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206694-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206694-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2017-10-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206694-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206694-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2017-10-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206694-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206694-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2017-10-27	`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	A206694-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206694-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206694-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206694-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206694-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206694-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206694-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206694-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206694-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206694-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206694-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206694-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206694-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206694-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206694-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206694-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206694-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206694-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206694-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206694-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206694-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206694-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206694-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206694-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206694-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206694-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206694-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206694-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206694-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206694-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206694-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206694-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206694-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206694-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206694-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206694-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206694-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206694-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206694-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206694-002	AB	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68382-827-01	EA - Each	68382-827	1c70f0df-cd4f-44c8-849f-a9d63e9e25bf	1	2018-04-19
68382-827-06	EA - Each	68382-827	c39fcada-5727-4460-85d2-2f152d46ea97	1	2018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68382-827	TAMOXIFEN CITRATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.]	5	Legacy NDC	20221115_fa87c1c2-f58b-4a12-a658-a957ae7e522d.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68382-827-01	68382082701	100 TABLET, FILM COATED in 1 BOTTLE (68382-827-01)	2018-01-03	0000-00-00	No	No	Current
68382-827-06	68382082706	30 TABLET, FILM COATED in 1 BOTTLE (68382-827-06)	2018-01-03	0000-00-00	No	No	Current
68382-827-10	68382082710	1000 TABLET, FILM COATED in 1 BOTTLE (68382-827-10)	2018-01-03	0000-00-00	No	No	Current
68382-827-14	68382082714	60 TABLET, FILM COATED in 1 BOTTLE (68382-827-14)	2018-01-03	0000-00-00	No	No	Current
68382-827-16	68382082716	90 TABLET, FILM COATED in 1 BOTTLE (68382-827-16)	2018-01-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tamoxifen Citrate Tablets, USP	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	2022-11-12	HUMAN PRESCRIPTION DRUG LABEL	5
Tamoxifen Citrate Tablets, USP	Bryant Ranch Prepack	2021-12-28	HUMAN PRESCRIPTION DRUG LABEL	3