Alprazolam

Product NDC: 63187-225
11-digit product format: 631870225
Labeler code: 63187
Product ID: 63187-225_525278ca-7947-41ac-92cf-b5a4e90dc56c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Alprazolam
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA074112
Marketing category: ANDA
Marketing start: 1995-12-29
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 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A074112-001	ALPRAZOLAM	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29
A074112-002	ALPRAZOLAM	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29
A074112-003	ALPRAZOLAM	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A074112-001	AB
A074112-002	AB
A074112-003	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 4 · 126 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	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074112-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074112-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074112-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074112-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074112-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074112-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074112-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074112-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074112-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074112-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074112-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074112-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074112-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074112-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074112-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074112-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074112-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074112-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074112-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074112-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074112-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074112-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074112-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074112-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074112-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074112-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A074112-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074112-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074112-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074112-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074112-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074112-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074112-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074112-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074112-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074112-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074112-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074112-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074112-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074112-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074112-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074112-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074112-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074112-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074112-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074112-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074112-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074112-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074112-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074112-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074112-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074112-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074112-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074112-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074112-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074112-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074112-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074112-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074112-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074112-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074112-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074112-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074112-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074112-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074112-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074112-001	AB	1	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: Alprazolam
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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197321	Internal RxNorm lookup
197322	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
717ce509-f92e-4ec1-a3c6-aeae54d56f4d	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
63187-225-30	Alprazolam	30 in 1 BOTTLE	TABLET	30	6
63187-225-60	Alprazolam	60 in 1 BOTTLE	TABLET	60	6
63187-225-90	Alprazolam	90 in 1 BOTTLE	TABLET	90	6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALPRAZOLAM	ACTIVE INGREDIENT	YU55MQ3IZY	ALPRAZOLAM TABLET [PROFICIENT RX LP]	2
ALPRAZOLAM	ACTIVE MOIETY	YU55MQ3IZY	ALPRAZOLAM TABLET [PROFICIENT RX LP]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALPRAZOLAM TABLET [PROFICIENT RX LP]	2
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	ALPRAZOLAM TABLET [PROFICIENT RX LP]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ALPRAZOLAM TABLET [PROFICIENT RX LP]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ALPRAZOLAM TABLET [PROFICIENT RX LP]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ALPRAZOLAM TABLET [PROFICIENT RX LP]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALPRAZOLAM TABLET [PROFICIENT RX LP]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ALPRAZOLAM TABLET [PROFICIENT RX LP]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ALPRAZOLAM TABLET [PROFICIENT RX LP]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-225	ALPRAZOLAM TABLET [PROFICIENT RX LP]	6	Current NDC, Legacy NDC, 3 package rows	20200818_717ce509-f92e-4ec1-a3c6-aeae54d56f4d.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alprazolam	ALPRAZOLAM	A-S Medication Solutions	3c0cb60f-1c3a-48a6-ad16-f14351548412	2025-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074112 application number: ANDA074112
Alprazolam	ALPRAZOLAM	PD-Rx Pharmaceuticals, Inc.	0ffcdbab-17e4-4395-8155-5b6ad00be6c2	2025-02-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074112 application number: ANDA074112
Alprazolam	ALPRAZOLAM	Advanced Rx of Tennessee, LLC	f667458d-ddda-4e9e-e053-2995a90adb5a	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074112 application number: ANDA074112
Alprazolam	ALPRAZOLAM	REMEDYREPACK INC.	563e09db-2f3d-4ce8-b356-ae44477be6d0	2024-07-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074112 application number: ANDA074112
Alprazolam	ALPRAZOLAM	Advanced Rx Pharmacy of Tennessee, LLC	b39e2bc8-b691-0f4e-e053-2995a90a00fd	2024-07-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074112 application number: ANDA074112
Alprazolam	ALPRAZOLAM	Sandoz Inc	d9b0e228-17cf-40d7-b62e-5050311c571c	2024-05-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074112 application number: ANDA074112
Alprazolam	ALPRAZOLAM	Aphena Pharma Solutions - Tennessee, LLC	f95f4030-e8e0-416f-951d-c4dac09f386a	2023-09-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074112 application number: ANDA074112
Alprazolam	ALPRAZOLAM	Aphena Pharma Solutions - Tennessee, LLC	54c790c5-2e6c-439d-8e3b-7502c962a596	2023-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074112 application number: ANDA074112
Alprazolam	ALPRAZOLAM	Proficient Rx LP	717ce509-f92e-4ec1-a3c6-aeae54d56f4d	2020-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074112 application number: ANDA074112 ndc (product): 63187-225
Alprazolam	ALPRAZOLAM	Proficient Rx LP	447efe78-3696-481c-bbae-23199a39ec94	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074112 application number: ANDA074112

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
308048	ALPRAZolam 0.5 MG Oral Tablet	PSN	717ce509-f92e-4ec1-a3c6-aeae54d56f4d	6
197321	ALPRAZolam 1 MG Oral Tablet	PSN	717ce509-f92e-4ec1-a3c6-aeae54d56f4d	6
197322	ALPRAZolam 2 MG Oral Tablet	PSN	717ce509-f92e-4ec1-a3c6-aeae54d56f4d	6
308048	alprazolam 0.5 MG Oral Tablet	SCD	717ce509-f92e-4ec1-a3c6-aeae54d56f4d	6
197321	alprazolam 1 MG Oral Tablet	SCD	717ce509-f92e-4ec1-a3c6-aeae54d56f4d	6
197322	alprazolam 2 MG Oral Tablet	SCD	717ce509-f92e-4ec1-a3c6-aeae54d56f4d	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-225-30	63187022530	30 TABLET in 1 BOTTLE (63187-225-30)	30 tablet	2014-03-03	0000-00-00	No	No	Current
63187-225-60	63187022560	60 TABLET in 1 BOTTLE (63187-225-60)	60 tablet	2014-03-03	0000-00-00	No	No	Current
63187-225-90	63187022590	90 TABLET in 1 BOTTLE (63187-225-90)	90 tablet	2014-03-03	0000-00-00	No	No	Current