ALPRAZOLAM

Product NDC: 61919-379
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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	61919-379		I	Inactivated by FDA		2026-09-14
excluded package	package	61919-379	61919-379-30	I	Inactivated by FDA		2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-379-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-379-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-379-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-379-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-379-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-379-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-379-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-379-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-379-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-379-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-379-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-379-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61919-379-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61919-379-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61919-379-30	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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.

Product history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078491-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	2008-09-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078491-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	2008-09-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078491-003	ALPRAZOLAM	1MG	TABLET / ORAL	2008-09-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078491-004	ALPRAZOLAM	2MG	TABLET / ORAL	2008-12-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078491-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	2008-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078491-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	2008-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078491-003	ALPRAZOLAM	1MG	TABLET / ORAL	2008-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078491-004	ALPRAZOLAM	2MG	TABLET / ORAL	2008-12-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078491-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	2008-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078491-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	2008-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078491-003	ALPRAZOLAM	1MG	TABLET / ORAL	2008-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078491-004	ALPRAZOLAM	2MG	TABLET / ORAL	2008-12-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078491-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	2008-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078491-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	2008-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078491-003	ALPRAZOLAM	1MG	TABLET / ORAL	2008-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078491-004	ALPRAZOLAM	2MG	TABLET / ORAL	2008-12-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078491-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	2008-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078491-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	2008-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078491-003	ALPRAZOLAM	1MG	TABLET / ORAL	2008-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078491-004	ALPRAZOLAM	2MG	TABLET / ORAL	2008-12-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078491-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	2008-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078491-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	2008-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078491-003	ALPRAZOLAM	1MG	TABLET / ORAL	2008-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078491-004	ALPRAZOLAM	2MG	TABLET / ORAL	2008-12-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078491-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	2008-09-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078491-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	2008-09-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078491-003	ALPRAZOLAM	1MG	TABLET / ORAL	2008-09-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078491-004	ALPRAZOLAM	2MG	TABLET / ORAL	2008-12-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078491-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	2008-09-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078491-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	2008-09-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078491-003	ALPRAZOLAM	1MG	TABLET / ORAL	2008-09-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078491-004	ALPRAZOLAM	2MG	TABLET / ORAL	2008-12-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078491-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	2008-09-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078491-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	2008-09-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078491-003	ALPRAZOLAM	1MG	TABLET / ORAL	2008-09-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078491-004	ALPRAZOLAM	2MG	TABLET / ORAL	2008-12-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078491-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	2008-09-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078491-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	2008-09-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078491-003	ALPRAZOLAM	1MG	TABLET / ORAL	2008-09-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078491-004	ALPRAZOLAM	2MG	TABLET / ORAL	2008-12-12	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A078491-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078491-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078491-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078491-004	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A078491-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078491-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078491-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078491-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078491-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078491-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078491-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078491-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078491-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078491-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078491-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078491-004	AB	1	`ea99ee380514…`

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