Alprazolam

Product NDC: 63187-445
11-digit product format: 631870445
Labeler code: 63187
Product ID: 63187-445_7522bce9-9d0b-4cf7-a57b-86301bbef471
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Alprazolam
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA090871
Marketing category: ANDA
Marketing start: 2011-06-07
Substance: ALPRAZOLAM
Active strength: 1 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 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
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 · 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	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…`
2024-10-29 15:01 UTC	2024-10	A090871-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090871-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090871-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090871-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-07	`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	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…`
2024-10-29 15:01 UTC	2024-10	A090871-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090871-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090871-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090871-004	AB	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Alprazolam
Listing expiration: 2026-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
433800	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
34631dbf-f817-484d-8bcf-f8efa07178d7	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
63187-445-30	Alprazolam	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	3
63187-445-60	Alprazolam	60 in 1 BOTTLE	TABLET, EXTENDED RELEASE	60	3
63187-445-90	Alprazolam	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90	3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALPRAZOLAM	ACTIVE INGREDIENT	YU55MQ3IZY	ALPRAZOLAM TABLET, EXTENDED RELEASE [PROFICIENT RX LP]	1
ALPRAZOLAM	ACTIVE MOIETY	YU55MQ3IZY	ALPRAZOLAM TABLET, EXTENDED RELEASE [PROFICIENT RX LP]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ALPRAZOLAM TABLET, EXTENDED RELEASE [PROFICIENT RX LP]	1
HYPROMELLOSE 2208 (100 MPA.S)	INACTIVE INGREDIENT	B1QE5P712K	ALPRAZOLAM TABLET, EXTENDED RELEASE [PROFICIENT RX LP]	1
HYPROMELLOSE 2208 (4000 MPA.S)	INACTIVE INGREDIENT	39J80LT57T	ALPRAZOLAM TABLET, EXTENDED RELEASE [PROFICIENT RX LP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ALPRAZOLAM TABLET, EXTENDED RELEASE [PROFICIENT RX LP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALPRAZOLAM TABLET, EXTENDED RELEASE [PROFICIENT RX LP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ALPRAZOLAM TABLET, EXTENDED RELEASE [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-445	ALPRAZOLAM TABLET, EXTENDED RELEASE [PROFICIENT RX LP]	3	Current NDC, Legacy NDC, 3 package rows	20210115_34631dbf-f817-484d-8bcf-f8efa07178d7.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 ndc (product): 63187-445
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
433800	ALPRAZolam 1 MG 24HR Extended Release Oral Tablet	PSN	34631dbf-f817-484d-8bcf-f8efa07178d7	3
433800	24 HR alprazolam 1 MG Extended Release Oral Tablet	SCD	34631dbf-f817-484d-8bcf-f8efa07178d7	3
433800	alprazolam 1 MG 24 HR Extended Release Oral Tablet	SY	34631dbf-f817-484d-8bcf-f8efa07178d7	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-445-30	63187044530	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-445-30)	2018-12-01	0000-00-00	No	No	Current
63187-445-60	63187044560	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-445-60)	2018-12-01	0000-00-00	No	No	Current
63187-445-90	63187044590	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-445-90)	2018-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Alprazolam Extended-Release Tablets USP CIV Rx only	Proficient Rx LP	2021-01-01	HUMAN PRESCRIPTION DRUG LABEL	3