Alprazolam

Product NDC: 68071-2794
Requested package NDC: 68071-2794-6
11-digit product format: 680712794
Labeler code: 68071
Product ID: 68071-2794_e4164d25-9eb4-72a8-e053-2a95a90a5d85
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Alprazolam
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA074342
Marketing category: ANDA
Marketing start: 1993-10-01
Marketing end: 0000-00-00
Substance: ALPRAZOLAM
Active strength: 0 mg/1
Pharmacologic classes: Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule: CIV
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68071-2794	68071-2794-6	I	Inactivated by FDA		2026-08-07

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A074342-001	ALPRAZOLAM	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-31
A074342-002	ALPRAZOLAM	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-31
A074342-003	ALPRAZOLAM	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-31
A074342-004	ALPRAZOLAM	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074342-001	AB
A074342-002	AB
A074342-003	AB
A074342-004	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 · 164 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	A074342-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074342-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074342-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074342-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074342-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074342-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074342-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074342-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074342-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074342-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074342-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074342-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074342-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074342-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074342-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074342-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074342-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074342-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074342-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074342-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074342-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074342-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074342-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074342-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074342-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074342-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074342-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074342-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074342-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074342-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074342-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074342-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074342-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074342-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074342-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074342-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074342-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074342-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074342-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074342-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-31	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A074342-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074342-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074342-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074342-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074342-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074342-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074342-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074342-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074342-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074342-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074342-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074342-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074342-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074342-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074342-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074342-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074342-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074342-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074342-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074342-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074342-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074342-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074342-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074342-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074342-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074342-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074342-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074342-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074342-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074342-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074342-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074342-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074342-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074342-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074342-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074342-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074342-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074342-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074342-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074342-004	AB	1	`d06236e962d9…`

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
68071-2794-6	2025-01-30	C162847	48780-1	2cef2736-b5d4-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2794-6	Alprazolam	6 in 1 BOTTLE	TABLET	6		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2794	ALPRAZOLAM TABLET [NUCARE PHARMACEUTICALS,INC.]	1	Legacy NDC, 1 package rows	20220720_e4164dff-4417-f883-e053-2995a90aae85.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alprazolam	ALPRAZOLAM	A-S Medication Solutions	8ef75d22-4a7c-48d5-a532-5a43b8593e7c	2026-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074342 application number: ANDA074342
Alprazolam	ALPRAZOLAM	PD-Rx Pharmaceuticals, Inc.	5040e1ed-32d6-4757-a0ee-b8240f3e7cf5	2025-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074342 application number: ANDA074342
Alprazolam	ALPRAZOLAM	PD-Rx Pharmaceuticals, Inc.	2f16ff78-1262-4bb8-9a25-822c13c4746f	2025-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074342 application number: ANDA074342
Alprazolam	ALPRAZOLAM	Advanced Rx of Tennessee, LLC	b39e2bc8-b68f-0f4e-e053-2995a90a00fd	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074342 application number: ANDA074342
Alprazolam	ALPRAZOLAM	Advanced Rx of Tennessee, LLC	b4cd647f-1ba3-334e-e053-2995a90af352	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074342 application number: ANDA074342
Alprazolam	ALPRAZOLAM	Quality Care Products, LLC	8be0bc5e-3566-4fbd-a27d-634e64fd6d78	2024-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074342 application number: ANDA074342
Alprazolam	ALPRAZOLAM	NuCare Pharmaceuticals,Inc.	aaf7979c-168a-0da2-e053-2995a90a4d12	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074342 application number: ANDA074342
Alprazolam	ALPRAZOLAM	NuCare Pharmaceuticals,Inc.	b43df4ca-8d28-7b3a-e053-2a95a90aa4d7	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074342 application number: ANDA074342
Alprazolam	ALPRAZOLAM	Bryant Ranch Prepack	8ca8e0fc-6c3d-48d4-ad04-708182b45350	2024-05-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074342 application number: ANDA074342
Alprazolam	ALPRAZOLAM	Bryant Ranch Prepack	25781f50-d309-4c4f-9e21-c019e068d101	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074342 application number: ANDA074342
Alprazolam	ALPRAZOLAM	Actavis Pharma, Inc.	a23063c0-099a-4256-b95f-3a857bbf704b	2023-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074342 application number: ANDA074342
Alprazolam	ALPRAZOLAM	Aphena Pharma Solutions - Tennessee, LLC	29ddd9f2-c116-467b-8db3-38166482aea0	2018-08-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074342 application number: ANDA074342
Alprazolam	ALPRAZOLAM	Aphena Pharma Solutions - Tennessee, LLC	2717699a-c8b6-4590-937a-cb86eadc5296	2018-08-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074342 application number: ANDA074342

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
308047	ALPRAZolam 0.25 MG Oral Tablet	PSN	e4164dff-4417-f883-e053-2995a90aae85	1
308047	alprazolam 0.25 MG Oral Tablet	SCD	e4164dff-4417-f883-e053-2995a90aae85	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2794-6	68071279406	6 TABLET in 1 BOTTLE (68071-2794-6)	6 tablet	2022-07-18	0000-00-00	No	No	Current