ALPRAZOLAM

Product NDC: 61919-379
Requested package NDC: 61919-379-30
11-digit product format: 619190379
Labeler code: 61919
Product ID: 61919-379_92d922a0-5a29-9cf9-e053-2995a90a0cbd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ALPRAZOLAM
Dosage form: TABLET
Route: ORAL
Labeler: Direct_Rx
Application: ANDA078491
Marketing category: ANDA
Marketing start: 2017-11-01
Marketing end: 0000-00-00
Substance: ALPRAZOLAM
Active strength: 0 mg/1
Pharmacologic classes: Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	61919-379	61919-379-30	I	Inactivated by FDA		2026-08-03

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	Approval date
A078491-001	ALPRAZOLAM	ALPRAZOLAM	0.25MG	TABLET / ORAL	2008-09-25
A078491-002	ALPRAZOLAM	ALPRAZOLAM	0.5MG	TABLET / ORAL	2008-09-25
A078491-003	ALPRAZOLAM	ALPRAZOLAM	1MG	TABLET / ORAL	2008-09-25
A078491-004	ALPRAZOLAM	ALPRAZOLAM	2MG	TABLET / ORAL	2008-12-12

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	Approval date	Source SHA-256
2022-11-12 20:34 UTC	2022-11	A078491-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	2008-09-25	`3a93d1ddd44b…`
2022-11-12 20:34 UTC	2022-11	A078491-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	2008-09-25	`3a93d1ddd44b…`
2022-11-12 20:34 UTC	2022-11	A078491-003	ALPRAZOLAM	1MG	TABLET / ORAL	2008-09-25	`3a93d1ddd44b…`
2022-11-12 20:34 UTC	2022-11	A078491-004	ALPRAZOLAM	2MG	TABLET / ORAL	2008-12-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078491-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	2008-09-25	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A078491-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	2008-09-25	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A078491-003	ALPRAZOLAM	1MG	TABLET / ORAL	2008-09-25	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A078491-004	ALPRAZOLAM	2MG	TABLET / ORAL	2008-12-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078491-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	2008-09-25	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A078491-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	2008-09-25	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A078491-003	ALPRAZOLAM	1MG	TABLET / ORAL	2008-09-25	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A078491-004	ALPRAZOLAM	2MG	TABLET / ORAL	2008-12-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078491-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	2008-09-25	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078491-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	2008-09-25	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078491-003	ALPRAZOLAM	1MG	TABLET / ORAL	2008-09-25	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078491-004	ALPRAZOLAM	2MG	TABLET / ORAL	2008-12-12	`cb3db0bc1861…`
2026-08-01 22:54:32	2026-06	A078491-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	2008-09-25	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078491-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	2008-09-25	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078491-003	ALPRAZOLAM	1MG	TABLET / ORAL	2008-09-25	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078491-004	ALPRAZOLAM	2MG	TABLET / ORAL	2008-12-12	`a50c72e98297…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-379-30	2023-01-30	C162847	48780-1	f386c649-e5ef-0266-e053-dadaa90a7c1a	ALPRAZOLAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-379-30	ALPRAZOLAM	30 in 1 BOTTLE	TABLET	30		6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALPRAZOLAM	ACTIVE INGREDIENT	YU55MQ3IZY	ALPRAZOLAM TABLET [DIRECT RX]	1
ALPRAZOLAM	ACTIVE MOIETY	YU55MQ3IZY	ALPRAZOLAM TABLET [DIRECT RX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALPRAZOLAM TABLET [DIRECT RX]	1
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	ALPRAZOLAM TABLET [DIRECT RX]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ALPRAZOLAM TABLET [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALPRAZOLAM TABLET [DIRECT RX]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ALPRAZOLAM TABLET [DIRECT RX]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ALPRAZOLAM TABLET [DIRECT RX]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ALPRAZOLAM TABLET [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-379	ALPRAZOLAM TABLET [DIRECT_RX]	6	Legacy NDC, 1 package rows	20190919_bc9dff5c-db3b-4cdf-b0bc-7ef94fd38486.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	bc9dff5c-db3b-4cdf-b0bc-7ef94fd38486	6
308047	alprazolam 0.25 MG Oral Tablet	SCD	bc9dff5c-db3b-4cdf-b0bc-7ef94fd38486	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-379-30	61919037930	30 TABLET in 1 BOTTLE (61919-379-30)	30 tablet	2019-09-18	0000-00-00	No	No	Current