ALPRAZOLAM

Product NDC: 52959-964
Requested package NDC: 52959-964-60
11-digit product format: 529590964
Labeler code: 52959
Product ID: 52959-964_79619e0f-1603-40ea-e053-2a91aa0a2700
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ALPRAZOLAM
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: H.J. Harkins Company, Inc.
Application: ANDA090871
Marketing category: ANDA
Marketing start: 2015-12-14
Marketing end: 0000-00-00
Substance: ALPRAZOLAM
Active strength: 1 mg/1
Pharmacologic classes: Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule: CIV
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	52959-964	52959-964-60	I	Inactivated by FDA		2026-08-17

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 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090871-001	ALPRAZOLAM	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07
A090871-002	ALPRAZOLAM	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07
A090871-003	ALPRAZOLAM	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07
A090871-004	ALPRAZOLAM	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A090871-001	AB
A090871-002	AB
A090871-003	AB
A090871-004	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 5 · 168 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
2026-08-18 06:07:40	2026-07	A090871-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090871-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090871-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090871-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090871-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090871-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090871-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090871-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090871-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090871-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090871-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090871-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090871-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090871-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090871-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090871-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090871-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090871-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090871-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090871-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090871-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090871-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090871-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090871-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090871-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090871-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090871-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090871-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090871-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090871-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090871-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090871-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090871-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090871-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090871-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090871-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090871-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090871-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090871-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090871-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A090871-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090871-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090871-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090871-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090871-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090871-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090871-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090871-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090871-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090871-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090871-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090871-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090871-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090871-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090871-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090871-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090871-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090871-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090871-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090871-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090871-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090871-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090871-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090871-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090871-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090871-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090871-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090871-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090871-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090871-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090871-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090871-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090871-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090871-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090871-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090871-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090871-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090871-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090871-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090871-004	AB	1	`d8e5a09893c0…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2ffbe5ef-58ff-88b9-e291-045e0f861f4f	Product name	4	20180827
1f9e6d58-49d3-d9c1-e570-4bb0466a2c0b	Product name	1	20140508
a1a11520-f3e2-68fa-8bd9-e80b271ef797	Product name	1	20140508
d153678e-a3c8-bad8-cfe0-385656dde0e7	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52959-964-30	2022-01-28	C162847	48780-1	d6a99b39-b8a5-a426-e053-dadaa90af4c2	0964 ALPRAZOLAM ER
52959-964-60	2022-01-28	C162847	48780-1	d6a99b39-b8a5-a426-e053-dadaa90af4c2	0964 ALPRAZOLAM ER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52959-964-30	ALPRAZOLAMER	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30		1
52959-964-60	ALPRAZOLAMER	60 in 1 BOTTLE	TABLET, EXTENDED RELEASE	60		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-964	ALPRAZOLAM ER (ALPRAZOLAM) TABLET, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]	1	Legacy NDC, 2 package rows	20190116_79619e0f-1600-40ea-e053-2a91aa0a2700.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
Alprazolam	ALPRAZOLAM	Bryant Ranch Prepack	aaab422d-c763-4352-8ffc-5aafdf91e8dd	2026-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090871 application number: ANDA090871
Alprazolam	ALPRAZOLAM	Bryant Ranch Prepack	0dce8232-0b0e-4f81-af95-36e6febdb550	2026-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090871 application number: ANDA090871
Alprazolam	ALPRAZOLAM	Aurobindo Pharma Limited	326fa31a-5420-429b-9f7f-170cb38f64bd	2025-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090871 application number: ANDA090871
Alprazolam	ALPRAZOLAM	Asclemed USA, Inc.	5d839a8b-0f45-42bf-acc1-2bd28f948e53	2024-01-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090871 application number: ANDA090871
Alprazolam	ALPRAZOLAM	Proficient Rx LP	34631dbf-f817-484d-8bcf-f8efa07178d7	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090871 application number: ANDA090871
Alprazolam	ALPRAZOLAM	Proficient Rx LP	969acb29-3b5c-47ed-8f7d-a960a24e72e3	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090871 application number: ANDA090871

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
YU55MQ3IZY	ALPRAZOLAM	28981-97-7	ALPRAZOLAM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
433798	ALPRAZolam 0.5 MG 24HR Extended Release Oral Tablet	PSN	79619e0f-1600-40ea-e053-2a91aa0a2700	1
433798	24 HR alprazolam 0.5 MG Extended Release Oral Tablet	SCD	79619e0f-1600-40ea-e053-2a91aa0a2700	1
433798	alprazolam 0.5 MG 24 HR Extended Release Oral Tablet	SY	79619e0f-1600-40ea-e053-2a91aa0a2700	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
52959-964-60	52959096460	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (52959-964-60)	2015-12-14	0000-00-00	No	No	Current