Alprazolam

Product NDC: 58118-0678
11-digit product format: 581180678
Labeler code: 58118
Product ID: 58118-0678_57af6374-250e-6605-e063-6394a90a7df7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Alprazolam
Dosage form: TABLET
Route: ORAL
Labeler: Clinical Solutions Wholesale, LLC
Application: ANDA203346
Marketing category: ANDA
Marketing start: 2015-07-31
Substance: ALPRAZOLAM
Active strength: 1 mg/1
Pharmacologic classes: Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A203346-001	ALPRAZOLAM	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	2015-07-31
A203346-002	ALPRAZOLAM	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	2015-07-31
A203346-003	ALPRAZOLAM	ALPRAZOLAM	1MG	TABLET / ORAL	AB	2015-07-31
A203346-004	ALPRAZOLAM	ALPRAZOLAM	2MG	TABLET / ORAL	AB	2015-07-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203346-001	AB
A203346-002	AB
A203346-003	AB
A203346-004	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 · 172 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
2026-09-14 22:38:34	2026-08	A203346-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	2015-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203346-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	2015-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203346-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	2015-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203346-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	2015-07-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203346-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	2015-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203346-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	2015-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203346-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	2015-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203346-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	2015-07-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203346-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	2015-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203346-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	2015-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203346-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	2015-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203346-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	2015-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203346-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	2015-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203346-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	2015-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203346-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	2015-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203346-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	2015-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203346-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	2015-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203346-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	2015-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203346-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	2015-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203346-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	2015-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203346-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	2015-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203346-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	2015-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203346-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	2015-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203346-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	2015-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203346-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	2015-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203346-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	2015-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203346-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	2015-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203346-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	2015-07-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203346-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	2015-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203346-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	2015-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203346-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	2015-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203346-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	2015-07-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203346-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	2015-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203346-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	2015-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203346-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	2015-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203346-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	2015-07-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203346-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	2015-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203346-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	2015-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203346-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	2015-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203346-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	2015-07-31	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A203346-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203346-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203346-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203346-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203346-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203346-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203346-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203346-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203346-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203346-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203346-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203346-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203346-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203346-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203346-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203346-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203346-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203346-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203346-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203346-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203346-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203346-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203346-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203346-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203346-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203346-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203346-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203346-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203346-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203346-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203346-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203346-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203346-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203346-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203346-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203346-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203346-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203346-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203346-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203346-004	AB	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Alprazolam
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALPRAZOLAM	1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
YU55MQ3IZY	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197321	Internal RxNorm lookup
197322	Internal RxNorm lookup
308047	Internal RxNorm lookup
308048	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
0cf8b567-201b-44fa-8fd3-c74023aff44f	Available on FDA.report

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 2 of 2 · 29 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alprazolam	ALPRAZOLAM	NuCare Pharmaceuticals, Inc.	315b8cf2-01a0-3f7d-e063-6394a90a39b5	2025-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203346 application number: ANDA203346
Alprazolam	ALPRAZOLAM	Direct_Rx	f77cfdd0-847d-4edd-e053-6394a90a91b7	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203346 application number: ANDA203346
Alprazolam	ALPRAZOLAM	NuCare Pharmaceuticals,Inc.	02840ea6-e4a0-96a0-e063-6394a90a19ae	2025-01-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203346 application number: ANDA203346
Alprazolam	ALPRAZOLAM	American Health Packaging	ea95d182-453b-4c43-8402-d65c488d55f2	2024-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203346 application number: ANDA203346
Alprazolam	ALPRAZOLAM	Advanced Rx of Tennessee, LLC	26f8b63c-6dad-8fac-e063-6394a90a5435	2024-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203346 application number: ANDA203346
Alprazolam	ALPRAZOLAM	NuCare Pharmaceuticals,Inc.	f7e63d96-2310-4ab1-e053-6294a90a86fc	2024-09-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203346 application number: ANDA203346
Alprazolam	ALPRAZOLAM	Medsource Pharmaceuticals	14960c0c-555f-acc1-e063-6394a90a232a	2024-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203346 application number: ANDA203346
Alprazolam	ALPRAZOLAM	NuCare Pharmaceuticals,Inc.	f9903822-642d-e364-e053-6394a90a22d8	2024-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203346 application number: ANDA203346
Alprazolam	ALPRAZOLAM	Proficient Rx LP	68e6ef8c-4104-4636-9719-6aa386c892d9	2023-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203346 application number: ANDA203346

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
58118-0678-8	58118067808	30 TABLET in 1 BLISTER PACK (58118-0678-8)	30 tablet	2026-07-28	No	No	Current