Alprazolam

Product NDC: 45865-424
11-digit product format: 458650424
Labeler code: 45865
Product ID: 45865-424_1b66047b-478c-4808-e054-00144ff8d46c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: alprazolam
Dosage form: TABLET
Route: ORAL
Labeler: Medsource Pharmaceuticals
Application: ANDA078491
Marketing category: ANDA
Marketing start: 2008-09-25
Marketing end: 0000-00-00
Substance: ALPRAZOLAM
Active strength: 1 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	45865-424		I	Inactivated by FDA	2026-08-11
excluded package	package	45865-424	45865-424-30	I	Inactivated by FDA	2026-08-11
excluded package	package	45865-424	45865-424-60	I	Inactivated by FDA	2026-08-11

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 · 27 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-424-60	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-424-30	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-424-60	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-424-30	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-424-60	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-424-30	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-424-60	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-424-30	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45865-424-60	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45865-424-30	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45865-424-60	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45865-424-30	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45865-424-30	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45865-424-60	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45865-424-30	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45865-424-60	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45865-424-30	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45865-424-60	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078491-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	2008-09-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078491-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	2008-09-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078491-003	ALPRAZOLAM	1MG	TABLET / ORAL	2008-09-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078491-004	ALPRAZOLAM	2MG	TABLET / ORAL	2008-12-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078491-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	2008-09-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078491-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	2008-09-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078491-003	ALPRAZOLAM	1MG	TABLET / ORAL	2008-09-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078491-004	ALPRAZOLAM	2MG	TABLET / ORAL	2008-12-12	`d06236e962d9…`

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
45865-424-30	2025-01-30	C162847	48780-1	2cef2736-7470-d83d-e063-dadaa90ab31f	ALPRAZOLAM TABLETS, USP 0.25 mg, 0.5 mg, 1 mg and 2 mg
45865-424-60	2025-01-30	C162847	48780-1	2cef2736-7470-d83d-e063-dadaa90ab31f	ALPRAZOLAM TABLETS, USP 0.25 mg, 0.5 mg, 1 mg and 2 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45865-424-30	Alprazolam	30 in 1 BOTTLE, PLASTIC	TABLET	30		2
45865-424-60	Alprazolam	60 in 1 BOTTLE, PLASTIC	TABLET	60		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALPRAZOLAM	ACTIVE INGREDIENT	YU55MQ3IZY	ALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]	2
ALPRAZOLAM	ACTIVE MOIETY	YU55MQ3IZY	ALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]	2
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	ALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-424	ALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]	2	Legacy NDC, 2 package rows	20150721_1b66a205-ad3f-0037-e054-00144ff88e88.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
308048	ALPRAZolam 0.5 MG Oral Tablet	PSN	1b66a205-ad3f-0037-e054-00144ff88e88	2
308048	alprazolam 0.5 MG Oral Tablet	SCD	1b66a205-ad3f-0037-e054-00144ff88e88	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45865-424-30	45865042430	30 TABLET in 1 BOTTLE, PLASTIC (45865-424-30)	30 tablet	2014-02-14	0000-00-00	No	No	Current
45865-424-60	45865042460	60 TABLET in 1 BOTTLE, PLASTIC (45865-424-60)	60 tablet	2014-02-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ALPRAZOLAM TABLETS, USP 0.25 mg, 0.5 mg, 1 mg and 2 mg	Medsource Pharmaceuticals	2015-07-21	HUMAN PRESCRIPTION DRUG LABEL	2