Alprazolam

Product NDC: 0781-1061
11-digit product format: 007811061
Labeler code: 0781
Product ID: 0781-1061_4c8c7366-aa3b-4124-9d64-67fb0ead6e15
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Alprazolam
Dosage form: TABLET
Route: ORAL
Labeler: Sandoz Inc
Application: ANDA074112
Marketing category: ANDA
Marketing start: 1995-12-29
Marketing end: 2027-03-19
Substance: ALPRAZOLAM
Active strength: .25 mg/1
Pharmacologic classes: Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
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 · 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 · 123 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	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…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074112-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074112-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	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…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074112-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074112-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074112-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Alprazolam

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALPRAZOLAM	.25 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
d9b0e228-17cf-40d7-b62e-5050311c571c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
2ffbe5ef-58ff-88b9-e291-045e0f861f4f	Product name	4	20180827
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
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
0781-1061-01	Alprazolam	100 in 1 BOTTLE	TABLET	100	21
0781-1061-05	Alprazolam	500 in 1 BOTTLE	TABLET	500	21
0781-1061-10	Alprazolam	1000 in 1 BOTTLE	TABLET	1000	21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-1061-01	EA - Each	0781-1061	e26674a9-ee7f-4367-96b3-67b51623fae1	1	2012-07-24
0781-1061-05	EA - Each	0781-1061	e5ab85b5-ed9b-4b6d-8826-6a6a552a1292	1	2012-07-24
0781-1061-10	EA - Each	0781-1061	3ce97ab7-1523-4716-bef7-70e491cb5812	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALPRAZOLAM	ACTIVE INGREDIENT	YU55MQ3IZY	ALPRAZOLAM TABLET [SANDOZ INC]	10
ALPRAZOLAM	ACTIVE MOIETY	YU55MQ3IZY	ALPRAZOLAM TABLET [SANDOZ INC]	10
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALPRAZOLAM TABLET [SANDOZ INC]	10
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	ALPRAZOLAM TABLET [SANDOZ INC]	10
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ALPRAZOLAM TABLET [SANDOZ INC]	10
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ALPRAZOLAM TABLET [SANDOZ INC]	10
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ALPRAZOLAM TABLET [SANDOZ INC]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALPRAZOLAM TABLET [SANDOZ INC]	10
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ALPRAZOLAM TABLET [SANDOZ INC]	10
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ALPRAZOLAM TABLET [SANDOZ INC]	10
Alprazolam	ACTIVE INGREDIENT	YU55MQ3IZY	ALPRAZOLAM TABLET [REDPHARM DRUG INC.]	4
Alprazolam	ACTIVE INGREDIENT	YU55MQ3IZY	ALPRAZOLAM TABLET [PREFERRED PHARMACEUTICALS, INC.]	4
Alprazolam	ACTIVE MOIETY	YU55MQ3IZY	ALPRAZOLAM TABLET [REDPHARM DRUG INC.]	4
Alprazolam	ACTIVE MOIETY	YU55MQ3IZY	ALPRAZOLAM TABLET [PREFERRED PHARMACEUTICALS, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALPRAZOLAM TABLET [REDPHARM DRUG INC.]	4
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	ALPRAZOLAM TABLET [PREFERRED PHARMACEUTICALS, INC.]	4
docusate sodium	INACTIVE INGREDIENT	F05Q2T2JA0	ALPRAZOLAM TABLET [REDPHARM DRUG INC.]	4
docusate sodium	INACTIVE INGREDIENT	F05Q2T2JA0	ALPRAZOLAM TABLET [PREFERRED PHARMACEUTICALS, INC.]	4
FD&C Blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	ALPRAZOLAM TABLET [PREFERRED PHARMACEUTICALS, INC.]	4
FD&C Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	ALPRAZOLAM TABLET [PREFERRED PHARMACEUTICALS, INC.]	4
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	ALPRAZOLAM TABLET [PREFERRED PHARMACEUTICALS, INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ALPRAZOLAM TABLET [REDPHARM DRUG INC.]	4
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	ALPRAZOLAM TABLET [REDPHARM DRUG INC.]	4
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	ALPRAZOLAM TABLET [PREFERRED PHARMACEUTICALS, INC.]	4
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	ALPRAZOLAM TABLET [PREFERRED PHARMACEUTICALS, INC.]	4
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	ALPRAZOLAM TABLET [REDPHARM DRUG INC.]	4
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	ALPRAZOLAM TABLET [PREFERRED PHARMACEUTICALS, INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ALPRAZOLAM TABLET [REDPHARM DRUG INC.]	4
ALPRAZOLAM	ACTIVE INGREDIENT	YU55MQ3IZY	ALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
ALPRAZOLAM	ACTIVE MOIETY	YU55MQ3IZY	ALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	ALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
Alprazolam	ACTIVE INGREDIENT	YU55MQ3IZY	ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]	1
Alprazolam	ACTIVE INGREDIENT	YU55MQ3IZY	ALPRAZOLAM TABLET [CONTRACT PHARMACY SERVICES-PA]	1
ALPRAZOLAM	ACTIVE INGREDIENT	YU55MQ3IZY	ALPRAZOLAM TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
ALPRAZOLAM	ACTIVE INGREDIENT	YU55MQ3IZY	ALPRAZOLAM TABLET [DIRECT RX]	1
ALPRAZOLAM	ACTIVE INGREDIENT	YU55MQ3IZY	ALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]	1
ALPRAZOLAM	ACTIVE MOIETY	YU55MQ3IZY	ALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]	1
ALPRAZOLAM	ACTIVE MOIETY	YU55MQ3IZY	ALPRAZOLAM TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
Alprazolam	ACTIVE MOIETY	YU55MQ3IZY	ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]	1
ALPRAZOLAM	ACTIVE MOIETY	YU55MQ3IZY	ALPRAZOLAM TABLET [DIRECT RX]	1
Alprazolam	ACTIVE MOIETY	YU55MQ3IZY	ALPRAZOLAM TABLET [CONTRACT PHARMACY SERVICES-PA]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	ALPRAZOLAM TABLET [CONTRACT PHARMACY SERVICES-PA]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALPRAZOLAM TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALPRAZOLAM TABLET [DIRECT RX]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]	1
docusate sodium	INACTIVE INGREDIENT	F05Q2T2JA0	ALPRAZOLAM TABLET [CONTRACT PHARMACY SERVICES-PA]	1
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	ALPRAZOLAM TABLET [DIRECT RX]	1
docusate sodium	INACTIVE INGREDIENT	F05Q2T2JA0	ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]	1
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	ALPRAZOLAM TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	ALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]	1
FD&C Blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ALPRAZOLAM TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
FD&C Blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	ALPRAZOLAM TABLET [CONTRACT PHARMACY SERVICES-PA]	1
FD&C Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	ALPRAZOLAM TABLET [CONTRACT PHARMACY SERVICES-PA]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ALPRAZOLAM TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
FD&C Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]	1
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	ALPRAZOLAM TABLET [CONTRACT PHARMACY SERVICES-PA]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ALPRAZOLAM TABLET [DIRECT RX]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ALPRAZOLAM TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]	1
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALPRAZOLAM TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	ALPRAZOLAM TABLET [CONTRACT PHARMACY SERVICES-PA]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALPRAZOLAM TABLET [DIRECT RX]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ALPRAZOLAM TABLET [DIRECT RX]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ALPRAZOLAM TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]	1
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	ALPRAZOLAM TABLET [CONTRACT PHARMACY SERVICES-PA]	1
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ALPRAZOLAM TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	ALPRAZOLAM TABLET [CONTRACT PHARMACY SERVICES-PA]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ALPRAZOLAM TABLET [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0781-1061	ALPRAZOLAM TABLET [SANDOZ INC]	21	Current NDC, Legacy NDC, 3 package rows	20241122_d9b0e228-17cf-40d7-b62e-5050311c571c.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 ndc (product): 0781-1061
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
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
308047	ALPRAZolam 0.25 MG Oral Tablet	PSN	3c0cb60f-1c3a-48a6-ad16-f14351548412	27
197321	ALPRAZolam 1 MG Oral Tablet	PSN	3c0cb60f-1c3a-48a6-ad16-f14351548412	27
197322	ALPRAZolam 2 MG Oral Tablet	PSN	3c0cb60f-1c3a-48a6-ad16-f14351548412	27
308047	alprazolam 0.25 MG Oral Tablet	SCD	3c0cb60f-1c3a-48a6-ad16-f14351548412	27
197321	alprazolam 1 MG Oral Tablet	SCD	3c0cb60f-1c3a-48a6-ad16-f14351548412	27
197322	alprazolam 2 MG Oral Tablet	SCD	3c0cb60f-1c3a-48a6-ad16-f14351548412	27
308047	ALPRAZolam 0.25 MG Oral Tablet	PSN	d9b0e228-17cf-40d7-b62e-5050311c571c	21
308048	ALPRAZolam 0.5 MG Oral Tablet	PSN	d9b0e228-17cf-40d7-b62e-5050311c571c	21
197321	ALPRAZolam 1 MG Oral Tablet	PSN	d9b0e228-17cf-40d7-b62e-5050311c571c	21
197322	ALPRAZolam 2 MG Oral Tablet	PSN	d9b0e228-17cf-40d7-b62e-5050311c571c	21
308047	alprazolam 0.25 MG Oral Tablet	SCD	d9b0e228-17cf-40d7-b62e-5050311c571c	21
308048	alprazolam 0.5 MG Oral Tablet	SCD	d9b0e228-17cf-40d7-b62e-5050311c571c	21
197321	alprazolam 1 MG Oral Tablet	SCD	d9b0e228-17cf-40d7-b62e-5050311c571c	21
197322	alprazolam 2 MG Oral Tablet	SCD	d9b0e228-17cf-40d7-b62e-5050311c571c	21
308047	ALPRAZolam 0.25 MG Oral Tablet	PSN	041ae7f6-7e42-4803-a015-f3bfcce277ba	4
308047	alprazolam 0.25 MG Oral Tablet	SCD	041ae7f6-7e42-4803-a015-f3bfcce277ba	4
308047	ALPRAZolam 0.25 MG Oral Tablet	PSN	447efe78-3696-481c-bbae-23199a39ec94	3
308047	ALPRAZolam 0.25 MG Oral Tablet	PSN	97d4c3ba-77f2-4a0f-9bc1-688290dde567	3
308047	alprazolam 0.25 MG Oral Tablet	SCD	447efe78-3696-481c-bbae-23199a39ec94	3
308047	alprazolam 0.25 MG Oral Tablet	SCD	97d4c3ba-77f2-4a0f-9bc1-688290dde567	3
308047	ALPRAZolam 0.25 MG Oral Tablet	PSN	5fa2dc50-3589-49f7-8fcc-0f7c0e91b3b7	2
308048	ALPRAZolam 0.5 MG Oral Tablet	PSN	5fa2dc50-3589-49f7-8fcc-0f7c0e91b3b7	2
197321	ALPRAZolam 1 MG Oral Tablet	PSN	5fa2dc50-3589-49f7-8fcc-0f7c0e91b3b7	2
308047	alprazolam 0.25 MG Oral Tablet	SCD	5fa2dc50-3589-49f7-8fcc-0f7c0e91b3b7	2
308048	alprazolam 0.5 MG Oral Tablet	SCD	5fa2dc50-3589-49f7-8fcc-0f7c0e91b3b7	2
197321	alprazolam 1 MG Oral Tablet	SCD	5fa2dc50-3589-49f7-8fcc-0f7c0e91b3b7	2
308047	ALPRAZolam 0.25 MG Oral Tablet	PSN	116b82c7-e1d1-222a-e054-00144ff8d46c	1
308047	ALPRAZolam 0.25 MG Oral Tablet	PSN	366500a0-6e91-4aaf-802a-8966b1c5a3e5	1
308047	ALPRAZolam 0.25 MG Oral Tablet	PSN	d7a54ceb-2d80-4879-950f-cad362324086	1
308047	ALPRAZolam 0.25 MG Oral Tablet	PSN	54c790c5-2e6c-439d-8e3b-7502c962a596	1
308048	ALPRAZolam 0.5 MG Oral Tablet	PSN	d7a54ceb-2d80-4879-950f-cad362324086	1
308048	ALPRAZolam 0.5 MG Oral Tablet	PSN	366500a0-6e91-4aaf-802a-8966b1c5a3e5	1
197321	ALPRAZolam 1 MG Oral Tablet	PSN	d7a54ceb-2d80-4879-950f-cad362324086	1
197321	ALPRAZolam 1 MG Oral Tablet	PSN	366500a0-6e91-4aaf-802a-8966b1c5a3e5	1
197322	ALPRAZolam 2 MG Oral Tablet	PSN	d7a54ceb-2d80-4879-950f-cad362324086	1
308047	alprazolam 0.25 MG Oral Tablet	SCD	d7a54ceb-2d80-4879-950f-cad362324086	1
308047	alprazolam 0.25 MG Oral Tablet	SCD	366500a0-6e91-4aaf-802a-8966b1c5a3e5	1
308047	alprazolam 0.25 MG Oral Tablet	SCD	116b82c7-e1d1-222a-e054-00144ff8d46c	1
308047	alprazolam 0.25 MG Oral Tablet	SCD	54c790c5-2e6c-439d-8e3b-7502c962a596	1
308048	alprazolam 0.5 MG Oral Tablet	SCD	d7a54ceb-2d80-4879-950f-cad362324086	1
308048	alprazolam 0.5 MG Oral Tablet	SCD	366500a0-6e91-4aaf-802a-8966b1c5a3e5	1
197321	alprazolam 1 MG Oral Tablet	SCD	d7a54ceb-2d80-4879-950f-cad362324086	1
197321	alprazolam 1 MG Oral Tablet	SCD	366500a0-6e91-4aaf-802a-8966b1c5a3e5	1
197322	alprazolam 2 MG Oral Tablet	SCD	d7a54ceb-2d80-4879-950f-cad362324086	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-1061-01	00781106101	100 TABLET in 1 BOTTLE (0781-1061-01)	100 tablet	1995-12-29	2027-03-19	No	No	Current
0781-1061-05	00781106105	500 TABLET in 1 BOTTLE (0781-1061-05)	500 tablet	1995-12-29	2027-03-19	No	No	Current
0781-1061-10	00781106110	1000 TABLET in 1 BOTTLE (0781-1061-10)	1000 tablet	1995-12-29	2027-03-19	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Alprazolam	A-S Medication Solutions	2025-07-10	HUMAN PRESCRIPTION DRUG LABEL	27
Alprazolam	Sandoz Inc	2024-05-31	HUMAN PRESCRIPTION DRUG LABEL	21
Alprazolam	Aphena Pharma Solutions - Tennessee, LLC	2023-03-20	HUMAN PRESCRIPTION DRUG LABEL	1
Alprazolam Tablets, USP CIV	Preferred Pharmaceuticals, Inc.	2020-02-19	HUMAN PRESCRIPTION DRUG LABEL	6
Alprazolam Tablets, USP	NuCare Pharmaceuticals, Inc.	2020-01-22	HUMAN PRESCRIPTION DRUG LABEL	2
ALPRAZOLAM	DIRECT RX	2020-01-17	HUMAN PRESCRIPTION DRUG LABEL	3
Alprazolam Tablets, USP	Proficient Rx LP	2019-11-01	HUMAN PRESCRIPTION DRUG LABEL	3
Alprazolam Tablets, USP CIV	McKesson Corporation dba SKY Packaging \| McKesson Corporation dba RX Pak	2019-09-10	HUMAN PRESCRIPTION DRUG LABEL	10
Alprazolam Tablets, USP	NCS HealthCare of KY, Inc dba Vangard Labs	2016-02-04	HUMAN PRESCRIPTION DRUG LABEL	3
Alprazolam Tablets, USP	Blenheim Pharmacal, Inc.	2015-03-16	HUMAN PRESCRIPTION DRUG LABEL	1
Alprazolam Tablets, USP	Aphena Pharma Solutions - Tennessee, LLC	2014-04-16	HUMAN PRESCRIPTION DRUG LABEL	2
Alprazolam Tablets	RedPharm Drug Inc. \| Sandoz GmbH	2011-06-09	HUMAN PRESCRIPTION DRUG LABEL	4
Alprazolam Tablets, USP	Contract Pharmacy Services-PA	2011-03-25	HUMAN PRESCRIPTION DRUG LABEL	1
Alprazolam Tablets, USP	Rebel Distributors Corp.	2009-06-01	HUMAN PRESCRIPTION DRUG LABEL	1