Alprazolam

Product NDC: 72162-1059
11-digit product format: 721621059
Labeler code: 72162
Product ID: 72162-1059_6e4271db-f791-421e-8abd-65feddded931
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Alprazolam
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA078056
Marketing category: ANDA
Marketing start: 2007-03-12
Substance: ALPRAZOLAM
Active strength: .5 mg/1
Pharmacologic classes: Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2026-12-31
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	Approval date
A078056-001	ALPRAZOLAM	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	2007-02-13
A078056-002	ALPRAZOLAM	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	2007-02-13
A078056-003	ALPRAZOLAM	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	2007-02-13
A078056-004	ALPRAZOLAM	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	2007-02-13

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	A078056-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL		2007-02-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078056-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL		2007-02-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078056-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL		2007-02-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078056-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL		2007-02-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078056-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078056-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078056-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078056-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078056-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078056-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078056-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078056-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078056-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078056-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078056-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078056-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078056-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078056-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078056-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078056-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078056-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078056-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078056-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078056-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078056-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078056-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078056-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078056-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078056-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078056-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078056-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078056-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078056-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078056-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078056-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078056-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078056-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078056-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078056-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078056-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`5bbf6a4d5a75…`

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	A078056-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078056-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078056-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078056-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078056-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078056-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078056-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078056-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078056-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078056-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078056-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078056-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078056-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078056-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078056-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078056-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078056-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078056-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078056-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078056-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078056-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078056-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078056-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078056-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078056-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078056-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078056-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078056-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078056-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078056-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078056-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078056-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078056-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078056-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078056-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078056-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078056-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078056-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078056-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078056-004	AB	1	`d8e5a09893c0…`

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
Brand name suffix: Extended Release
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALPRAZOLAM	.5 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
433798	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
4f6e4656-689f-46a6-a8ed-54ee55583357	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
72162-1059-2	AlprazolamExtended Release	45 in 1 BOTTLE	TABLET, EXTENDED RELEASE	45	100
72162-1059-3	AlprazolamExtended Release	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	100
72162-1059-6	AlprazolamExtended Release	60 in 1 BOTTLE	TABLET, EXTENDED RELEASE	60	100
72162-1059-9	AlprazolamExtended Release	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90	100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72162-1059-2	EA - Each	72162-1059	ec462675-ded9-4f30-b427-bfa889334032	1	2023-10-16
72162-1059-3	EA - Each	72162-1059	5d393037-be8f-4970-8666-41f0048ff650	1	2023-10-16
72162-1059-6	EA - Each	72162-1059	70d88a55-63be-43c2-aa2c-ae0011153f13	1	2023-10-16
72162-1059-9	EA - Each	72162-1059	0b5a594d-11db-486e-9ec8-11651507d4f6	1	2023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72162-1059	ALPRAZOLAM EXTENDED RELEASE (ALPRAZOLAM) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	100	Current NDC, 4 package rows	20230511_4f6e4656-689f-46a6-a8ed-54ee55583357.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alprazolam Extended Release	ALPRAZOLAM	Bryant Ranch Prepack	29477df1-68aa-44b3-bf9e-80ecff6ce879	2024-05-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078056 application number: ANDA078056
Alprazolam Extended Release	ALPRAZOLAM	Bryant Ranch Prepack	4f6e4656-689f-46a6-a8ed-54ee55583357	2023-05-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078056 application number: ANDA078056 ndc (product): 72162-1059

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	4f6e4656-689f-46a6-a8ed-54ee55583357	100
433798	24 HR alprazolam 0.5 MG Extended Release Oral Tablet	SCD	4f6e4656-689f-46a6-a8ed-54ee55583357	100
433798	alprazolam 0.5 MG 24 HR Extended Release Oral Tablet	SY	4f6e4656-689f-46a6-a8ed-54ee55583357	100

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72162-1059-2	72162105902	45 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-1059-2)	2023-05-08	No	No	Current
72162-1059-3	72162105903	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-1059-3)	2023-05-08	No	No	Current
72162-1059-6	72162105906	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-1059-6)	2023-05-08	No	No	Current
72162-1059-9	72162105909	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-1059-9)	2023-05-08	No	No	Current