Disulfiram

Product NDC: 64980-172
11-digit product format: 649800172
Labeler code: 64980
Product ID: 64980-172_9bd05731-ba84-41f4-baca-ad5d1feebe0f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Disulfiram
Dosage form: TABLET
Route: ORAL
Labeler: Rising Pharmaceuticals, Inc.
Application: ANDA091619
Marketing category: ANDA
Marketing start: 2011-04-08
Marketing end: 0000-00-00
Substance: DISULFIRAM
Active strength: 500 mg/1
Pharmacologic classes: Acetyl Aldehyde Dehydrogenase Inhibitors [MoA],Aldehyde Dehydrogenase Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	64980-172		D	Discontinued by firm	2026-08-11
excluded package	package	64980-172	64980-172-01	D	Discontinued by firm	2026-08-11
excluded package	package	64980-172	64980-172-03	D	Discontinued by firm	2026-08-11

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 · 36 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	64980-172-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64980-172-03	`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	64980-172-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64980-172-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64980-172-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64980-172-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64980-172-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64980-172-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64980-172-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64980-172-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64980-172-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64980-172-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64980-172-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64980-172-03	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64980-172-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64980-172-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64980-172-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64980-172-03	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64980-172-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64980-172-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64980-172-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64980-172-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64980-172-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64980-172-03	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A091619-001	DISULFIRAM	DISULFIRAM	250MG	TABLET / ORAL	AB		2011-03-28
A091619-002	DISULFIRAM	DISULFIRAM	500MG	TABLET / ORAL	AB		2011-03-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091619-001	AB
A091619-002	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	A091619-001	DISULFIRAM	250MG	TABLET / ORAL	AB	2011-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091619-002	DISULFIRAM	500MG	TABLET / ORAL	AB	2011-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091619-001	DISULFIRAM	250MG	TABLET / ORAL	AB	2011-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091619-002	DISULFIRAM	500MG	TABLET / ORAL	AB	2011-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091619-001	DISULFIRAM	250MG	TABLET / ORAL	AB	2011-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091619-002	DISULFIRAM	500MG	TABLET / ORAL	AB	2011-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091619-001	DISULFIRAM	250MG	TABLET / ORAL	AB	2011-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091619-002	DISULFIRAM	500MG	TABLET / ORAL	AB	2011-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091619-001	DISULFIRAM	250MG	TABLET / ORAL	AB	2011-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091619-002	DISULFIRAM	500MG	TABLET / ORAL	AB	2011-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091619-001	DISULFIRAM	250MG	TABLET / ORAL	AB	2011-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091619-002	DISULFIRAM	500MG	TABLET / ORAL	AB	2011-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091619-001	DISULFIRAM	250MG	TABLET / ORAL	AB	2011-03-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091619-002	DISULFIRAM	500MG	TABLET / ORAL	AB	2011-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091619-001	DISULFIRAM	250MG	TABLET / ORAL	AB	2011-03-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091619-002	DISULFIRAM	500MG	TABLET / ORAL	AB	2011-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091619-001	DISULFIRAM	250MG	TABLET / ORAL	AB	2011-03-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091619-002	DISULFIRAM	500MG	TABLET / ORAL	AB	2011-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091619-001	DISULFIRAM	250MG	TABLET / ORAL	AB	2011-03-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091619-002	DISULFIRAM	500MG	TABLET / ORAL	AB	2011-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091619-001	DISULFIRAM	250MG	TABLET / ORAL	AB	2011-03-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091619-002	DISULFIRAM	500MG	TABLET / ORAL	AB	2011-03-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091619-001	DISULFIRAM	250MG	TABLET / ORAL	AB	2011-03-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091619-002	DISULFIRAM	500MG	TABLET / ORAL	AB	2011-03-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091619-001	DISULFIRAM	250MG	TABLET / ORAL	AB	2011-03-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091619-002	DISULFIRAM	500MG	TABLET / ORAL	AB	2011-03-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091619-001	DISULFIRAM	250MG	TABLET / ORAL	AB	2011-03-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091619-002	DISULFIRAM	500MG	TABLET / ORAL	AB	2011-03-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091619-001	DISULFIRAM	250MG	TABLET / ORAL	AB	2011-03-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091619-002	DISULFIRAM	500MG	TABLET / ORAL	AB	2011-03-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091619-001	DISULFIRAM	250MG	TABLET / ORAL	AB	2011-03-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091619-002	DISULFIRAM	500MG	TABLET / ORAL	AB	2011-03-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091619-001	DISULFIRAM	250MG	TABLET / ORAL	AB	2011-03-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091619-002	DISULFIRAM	500MG	TABLET / ORAL	AB	2011-03-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091619-001	DISULFIRAM	250MG	TABLET / ORAL	AB	2011-03-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091619-002	DISULFIRAM	500MG	TABLET / ORAL	AB	2011-03-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091619-001	DISULFIRAM	250MG	TABLET / ORAL	AB	2011-03-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091619-002	DISULFIRAM	500MG	TABLET / ORAL	AB	2011-03-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091619-001	DISULFIRAM	250MG	TABLET / ORAL	AB	2011-03-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091619-002	DISULFIRAM	500MG	TABLET / ORAL	AB	2011-03-28	`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	A091619-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091619-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091619-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091619-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091619-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091619-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091619-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091619-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091619-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091619-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091619-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091619-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091619-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091619-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091619-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091619-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091619-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091619-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091619-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091619-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091619-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091619-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091619-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091619-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091619-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091619-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091619-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091619-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091619-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091619-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091619-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091619-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091619-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091619-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091619-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091619-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091619-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091619-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091619-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091619-002	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
64980-172-01	EA - Each	64980-172	d180afa1-f9e8-42cd-b813-dce977dc93bc	1	2012-07-24
64980-172-03	EA - Each	64980-172	778fe714-9fb8-4270-8d14-ac12b5f6a7d6	1	2016-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DISULFIRAM	ACTIVE INGREDIENT	TR3MLJ1UAI	DISULFIRAM TABLET [RISING PHARMACEUTICALS, INC.]	3
DISULFIRAM	ACTIVE MOIETY	TR3MLJ1UAI	DISULFIRAM TABLET [RISING PHARMACEUTICALS, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DISULFIRAM TABLET [RISING PHARMACEUTICALS, INC.]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	DISULFIRAM TABLET [RISING PHARMACEUTICALS, INC.]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DISULFIRAM TABLET [RISING PHARMACEUTICALS, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DISULFIRAM TABLET [RISING PHARMACEUTICALS, INC.]	3
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	DISULFIRAM TABLET [RISING PHARMACEUTICALS, INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DISULFIRAM TABLET [RISING PHARMACEUTICALS, INC.]	3

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Disulfiram	DISULFIRAM	Sigmapharm Laboratories, LLC	40f5497f-fe84-43b2-8ff4-32d59edf3917	2024-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091619 application number: ANDA091619

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TR3MLJ1UAI	DISULFIRAM	97-77-8	DISULFIRAM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64980-172-03	64980017203	30 TABLET in 1 BOTTLE (64980-172-03)	30 tablet	2016-08-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Disulfiram Tablets, USP IN ALCOHOLISM	Rising Pharmaceuticals, Inc. \| Sigmapharm Laboratories, LLC	2016-08-10	HUMAN PRESCRIPTION DRUG LABEL	5