Alprazolam

Product NDC: 0781-1089
11-digit product format: 007811089
Labeler code: 0781
Product ID: 0781-1089_4c8c7366-aa3b-4124-9d64-67fb0ead6e15
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Alprazolam
Dosage form: TABLET
Route: ORAL
Labeler: Sandoz Inc
Application: ANDA074909
Marketing category: ANDA
Marketing start: 1998-03-25
Marketing end: 2027-03-19
Substance: ALPRAZOLAM
Active strength: 2 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074909-001	ALPRAZOLAM	ALPRAZOLAM	2MG	TABLET / ORAL	AB		1998-03-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074909-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB		1998-03-25	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A074909-001	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 5 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): 074909 application number: ANDA074909
Alprazolam	ALPRAZOLAM	PD-Rx Pharmaceuticals, Inc.	7538d0d0-346e-4c3e-8f7a-c1cac8ec8ed3	2025-01-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074909 application number: ANDA074909
Alprazolam	ALPRAZOLAM	Sandoz Inc	d9b0e228-17cf-40d7-b62e-5050311c571c	2024-05-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074909 application number: ANDA074909 ndc (product): 0781-1089
Alprazolam	ALPRAZOLAM	Bryant Ranch Prepack	b0000772-2514-45a2-a75d-1bbb13c29989	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074909 application number: ANDA074909
Alprazolam	ALPRAZOLAM	Proficient Rx LP	717ce509-f92e-4ec1-a3c6-aeae54d56f4d	2020-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074909 application number: ANDA074909

Additional Listing Data#

Finished product: Yes
Brand name base: Alprazolam

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALPRAZOLAM	2 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
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	Strength	SPL version
0781-1089-01	Alprazolam	100 in 1 BOTTLE	TABLET	100		21
0781-1089-05	Alprazolam	500 in 1 BOTTLE	TABLET	500		21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-1089-01	EA - Each	0781-1089	08d97cf7-1312-4ce2-98a6-8098a0dfc307	1	2012-07-24
0781-1089-05	EA - Each	0781-1089	889b2c15-1be7-43a6-a1d6-849252533fc7	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 [PROFICIENT RX LP]	2
Alprazolam	ACTIVE INGREDIENT	YU55MQ3IZY	ALPRAZOLAM TABLET [PD-RX PHARMACEUTICALS, INC.]	2
ALPRAZOLAM	ACTIVE MOIETY	YU55MQ3IZY	ALPRAZOLAM TABLET [PROFICIENT RX LP]	2
Alprazolam	ACTIVE MOIETY	YU55MQ3IZY	ALPRAZOLAM TABLET [PD-RX PHARMACEUTICALS, INC.]	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
Alprazolam	ACTIVE INGREDIENT	YU55MQ3IZY	ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]	1
Alprazolam	ACTIVE MOIETY	YU55MQ3IZY	ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]	1
docusate sodium	INACTIVE INGREDIENT	F05Q2T2JA0	ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]	1
FD&C Blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]	1
FD&C Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]	1
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]	1
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]	1
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0781-1089	ALPRAZOLAM TABLET [SANDOZ INC]	21	Current NDC, Legacy NDC, 2 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
197322	ALPRAZolam 2 MG Oral Tablet	PSN	7538d0d0-346e-4c3e-8f7a-c1cac8ec8ed3	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	7538d0d0-346e-4c3e-8f7a-c1cac8ec8ed3	21
197322	alprazolam 2 MG Oral Tablet	SCD	d9b0e228-17cf-40d7-b62e-5050311c571c	21
197322	ALPRAZolam 2 MG Oral Tablet	PSN	b0000772-2514-45a2-a75d-1bbb13c29989	9
197322	alprazolam 2 MG Oral Tablet	SCD	b0000772-2514-45a2-a75d-1bbb13c29989	9
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
197322	ALPRAZolam 2 MG Oral Tablet	PSN	60bb0c7a-5ab1-2ba8-e053-2a91aa0a1ec9	2
197322	alprazolam 2 MG Oral Tablet	SCD	60bb0c7a-5ab1-2ba8-e053-2a91aa0a1ec9	2
308047	ALPRAZolam 0.25 MG Oral Tablet	PSN	d7a54ceb-2d80-4879-950f-cad362324086	1
308048	ALPRAZolam 0.5 MG Oral Tablet	PSN	d7a54ceb-2d80-4879-950f-cad362324086	1
197321	ALPRAZolam 1 MG Oral Tablet	PSN	d7a54ceb-2d80-4879-950f-cad362324086	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
308048	alprazolam 0.5 MG Oral Tablet	SCD	d7a54ceb-2d80-4879-950f-cad362324086	1
197321	alprazolam 1 MG Oral Tablet	SCD	d7a54ceb-2d80-4879-950f-cad362324086	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
0781-1089-01	00781108901	100 TABLET in 1 BOTTLE (0781-1089-01)	100 tablet	1998-03-25	2027-03-19	No	No	Current
0781-1089-05	00781108905	500 TABLET in 1 BOTTLE (0781-1089-05)	500 tablet	1998-03-25	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	PD-Rx Pharmaceuticals, Inc.	2025-01-02	HUMAN PRESCRIPTION DRUG LABEL	21
Alprazolam	Sandoz Inc	2024-05-31	HUMAN PRESCRIPTION DRUG LABEL	21
Alprazolam	Bryant Ranch Prepack	2024-04-04	HUMAN PRESCRIPTION DRUG LABEL	9
Alprazolam Tablets, USP	NuCare Pharmaceuticals,Inc. \| NuCare Pharmceuticals,Inc.	2021-01-11	HUMAN PRESCRIPTION DRUG LABEL	2
Alprazolam Tablets, USP	Proficient Rx LP	2020-08-01	HUMAN PRESCRIPTION DRUG LABEL	6
Alprazolam Tablets, USP	Rebel Distributors Corp.	2009-06-01	HUMAN PRESCRIPTION DRUG LABEL	1