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

Additional Listing Data#

Finished product: Yes
Brand name base: Alprazolam

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALPRAZOLAM	.25 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	YU55MQ3IZY
Rxcui	197321, 197322, 308047, 308048

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 MOIETY	YU55MQ3IZY	ALPRAZOLAM TABLET [REDPHARM DRUG INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALPRAZOLAM TABLET [REDPHARM DRUG INC.]	4
docusate sodium	INACTIVE INGREDIENT	F05Q2T2JA0	ALPRAZOLAM TABLET [REDPHARM DRUG INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ALPRAZOLAM TABLET [REDPHARM DRUG INC.]	4
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	ALPRAZOLAM TABLET [REDPHARM DRUG INC.]	4
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	ALPRAZOLAM TABLET [REDPHARM DRUG 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 [DIRECT RX]	1
ALPRAZOLAM	ACTIVE INGREDIENT	YU55MQ3IZY	ALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]	1
Alprazolam	ACTIVE INGREDIENT	YU55MQ3IZY	ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]	1
Alprazolam	ACTIVE INGREDIENT	YU55MQ3IZY	ALPRAZOLAM TABLET [CONTRACT PHARMACY SERVICES-PA]	1
ALPRAZOLAM	ACTIVE MOIETY	YU55MQ3IZY	ALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]	1
ALPRAZOLAM	ACTIVE MOIETY	YU55MQ3IZY	ALPRAZOLAM TABLET [DIRECT RX]	1
Alprazolam	ACTIVE MOIETY	YU55MQ3IZY	ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]	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 [REBEL DISTRIBUTORS CORP.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALPRAZOLAM TABLET [DIRECT RX]	1
docusate sodium	INACTIVE INGREDIENT	F05Q2T2JA0	ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]	1
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	ALPRAZOLAM TABLET [DIRECT RX]	1
docusate sodium	INACTIVE INGREDIENT	F05Q2T2JA0	ALPRAZOLAM TABLET [CONTRACT PHARMACY SERVICES-PA]	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 [CONTRACT PHARMACY SERVICES-PA]	1
FD&C Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]	1
FD&C Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	ALPRAZOLAM TABLET [CONTRACT PHARMACY SERVICES-PA]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ALPRAZOLAM TABLET [DIRECT RX]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]	1
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]	1
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	ALPRAZOLAM TABLET [CONTRACT PHARMACY SERVICES-PA]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	ALPRAZOLAM TABLET [CONTRACT PHARMACY SERVICES-PA]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALPRAZOLAM TABLET [DIRECT RX]	1
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	ALPRAZOLAM TABLET [CONTRACT PHARMACY SERVICES-PA]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ALPRAZOLAM TABLET [DIRECT RX]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]	1
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]	1
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]	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

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	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	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

Alprazolam

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#