Alprazolam

Product NDC: 65862-679
Requested package NDC: 65862-679-39
11-digit product format: 658620679
Labeler code: 65862
Product ID: 65862-679_7527aeb7-8912-404d-afb7-8c692c84422b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Alprazolam
Dosage form: TABLET
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA203346
Marketing category: ANDA
Marketing start: 2015-07-31
Substance: ALPRAZOLAM
Active strength: 2 mg/1
Pharmacologic classes: Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished package	package	65862-679	65862-679-39	UNFINISHED	Active or certified unfinished drug listing		2026-08-17

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 · 21 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	`5b2001dcd8f5…`	`54b53d4dc9e4…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	TE codes	Approval date
A203346-001	ALPRAZOLAM	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	2015-07-31
A203346-002	ALPRAZOLAM	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	2015-07-31
A203346-003	ALPRAZOLAM	ALPRAZOLAM	1MG	TABLET / ORAL	AB	2015-07-31
A203346-004	ALPRAZOLAM	ALPRAZOLAM	2MG	TABLET / ORAL	AB	2015-07-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A203346-001	AB
A203346-002	AB
A203346-003	AB
A203346-004	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.

Product history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A203346-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	2015-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203346-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	2015-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203346-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	2015-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203346-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	2015-07-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203346-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	2015-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203346-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	2015-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203346-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	2015-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203346-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	2015-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203346-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	2015-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203346-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	2015-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203346-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	2015-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203346-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	2015-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203346-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	2015-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203346-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	2015-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203346-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	2015-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203346-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	2015-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203346-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	2015-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203346-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	2015-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203346-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	2015-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203346-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	2015-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203346-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	2015-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203346-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	2015-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203346-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	2015-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203346-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	2015-07-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203346-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	2015-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203346-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	2015-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203346-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	2015-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203346-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	2015-07-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203346-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	2015-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203346-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	2015-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203346-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	2015-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203346-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	2015-07-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203346-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	2015-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203346-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	2015-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203346-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	2015-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203346-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	2015-07-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203346-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	2015-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203346-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	2015-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203346-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	2015-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203346-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	2015-07-31	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A203346-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203346-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203346-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203346-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203346-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203346-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203346-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203346-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203346-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203346-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203346-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203346-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203346-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203346-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203346-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203346-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203346-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203346-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203346-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203346-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203346-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203346-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203346-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203346-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203346-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203346-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203346-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203346-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203346-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203346-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203346-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203346-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203346-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203346-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203346-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203346-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203346-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203346-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203346-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203346-004	AB	1	`d8e5a09893c0…`

Additional Listing Data#

Finished product: Yes
Brand name base: Alprazolam
Listing expiration: 2026-12-31

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
d2fd0b3e-9b78-44d0-82a6-96d6c6238750	Available on FDA.report

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
65862-679-01	Alprazolam	100 in 1 BOTTLE	TABLET	100	10
65862-679-05	Alprazolam	500 in 1 BOTTLE	TABLET	500	10
65862-679-99	Alprazolam	1000 in 1 BOTTLE	TABLET	1000	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-679-01	EA - Each	65862-679	67d99a4c-94c3-41e3-84ca-481580917c69	1	2020-04-20
65862-679-05	EA - Each	65862-679	538a94ce-729a-4d55-b371-a18a0b584f7a	1	2018-03-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALPRAZOLAM	ACTIVE INGREDIENT	YU55MQ3IZY	ALPRAZOLAM TABLET [AUROBINDO PHARMA LIMITED]	1
ALPRAZOLAM	ACTIVE MOIETY	YU55MQ3IZY	ALPRAZOLAM TABLET [AUROBINDO PHARMA LIMITED]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALPRAZOLAM TABLET [AUROBINDO PHARMA LIMITED]	1
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	ALPRAZOLAM TABLET [AUROBINDO PHARMA LIMITED]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ALPRAZOLAM TABLET [AUROBINDO PHARMA LIMITED]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ALPRAZOLAM TABLET [AUROBINDO PHARMA LIMITED]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ALPRAZOLAM TABLET [AUROBINDO PHARMA LIMITED]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALPRAZOLAM TABLET [AUROBINDO PHARMA LIMITED]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ALPRAZOLAM TABLET [AUROBINDO PHARMA LIMITED]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ALPRAZOLAM TABLET [AUROBINDO PHARMA LIMITED]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ALPRAZOLAM TABLET [AUROBINDO PHARMA LIMITED]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-679	ALPRAZOLAM TABLET [AUROBINDO PHARMA LIMITED]	8	Current NDC, Legacy NDC, 3 package rows	20230310_d2fd0b3e-9b78-44d0-82a6-96d6c6238750.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 29 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alprazolam	ALPRAZOLAM	Clinical Solutions Wholesale, LLC	0cf8b567-201b-44fa-8fd3-c74023aff44f	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203346 application number: ANDA203346
Alprazolam	ALPRAZOLAM	PD-Rx Pharmaceuticals, Inc.	4203d3fe-916e-41af-9daf-f58f4fed6f9c	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203346 application number: ANDA203346
Alprazolam	ALPRAZOLAM	St. Mary's Medical Park Pharmacy	fc5fe795-6b41-aecf-e053-6394a90af562	2026-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203346 application number: ANDA203346
Alprazolam	ALPRAZOLAM	Bryant Ranch Prepack	68d8b8d1-00a4-42c4-a796-90211fee1a6d	2026-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203346 application number: ANDA203346
Alprazolam	ALPRAZOLAM	Coupler LLC	5111e57d-8920-6861-e063-6294a90a2194	2026-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203346 application number: ANDA203346
Alprazolam	ALPRAZOLAM	ASCLEMED USA INC.	8d76a554-7ed1-4c93-a5ea-30898aec0aa1	2026-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203346 application number: ANDA203346
Alprazolam	ALPRAZOLAM	Coupler LLC	509a8a86-d61c-3f05-e063-6394a90a52ca	2026-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203346 application number: ANDA203346
Alprazolam	ALPRAZOLAM	Bryant Ranch Prepack	2bd0d4c6-0fde-46f2-bb13-da25d50427df	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203346 application number: ANDA203346
Alprazolam	ALPRAZOLAM	Bryant Ranch Prepack	d8364af1-d23e-4cd7-9a81-077ae97a951a	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203346 application number: ANDA203346
Alprazolam	ALPRAZOLAM	Bryant Ranch Prepack	0e2644fa-8334-4209-a63d-2466b5ab55b4	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203346 application number: ANDA203346
Alprazolam C-IV	ALPRAZOLAM C-IV	Direct_Rx	f6dd8005-1d50-41bc-e053-6394a90ac45b	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203346 application number: ANDA203346
Alprazolam	ALPRAZOLAM	Proficient Rx LP	c6795ed8-af28-41f4-b85b-48e1fe9d0369	2026-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203346 application number: ANDA203346
Alprazolam	ALPRAZOLAM	PreferredPharmaceuticals Inc.	dc130aae-4510-4de7-a750-4a144e88208d	2026-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203346 application number: ANDA203346
Alprazolam	ALPRAZOLAM	Preferred Pharmaceuticals Inc.	73c1d1dc-ade2-4bb4-b109-83bd63acd15c	2026-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203346 application number: ANDA203346
Alprazolam	ALPRAZOLAM	Preferred Pharmaceuticals Inc.	78682252-e448-4b20-b49d-27c2c70e4cb3	2026-02-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203346 application number: ANDA203346
Alprazolam	ALPRAZOLAM	Northwind Health Company, LLC	25174ee5-a86e-ab97-e063-6394a90acd87	2025-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203346 application number: ANDA203346
Alprazolam	ALPRAZOLAM	Aurobindo Pharma Limited	d2fd0b3e-9b78-44d0-82a6-96d6c6238750	2025-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203346 application number: ANDA203346 ndc (product): 65862-679
Alprazolam	ALPRAZOLAM	AvPAK	3fa14fa4-45a7-6ef4-e063-6394a90a1dcd	2025-09-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203346 application number: ANDA203346
Alprazolam C-IV	ALPRAZOLAM C-IV	Direct_Rx	f6dd0e94-4a79-769f-e053-6394a90a5ae6	2025-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203346 application number: ANDA203346
Alprazolam	ALPRAZOLAM	NuCare Pharmaceuticals, Inc.	315b5782-969a-4324-e063-6394a90acf37	2025-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203346 application number: ANDA203346

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
197322	ALPRAZolam 2 MG Oral Tablet	PSN	68d8b8d1-00a4-42c4-a796-90211fee1a6d	104
197322	alprazolam 2 MG Oral Tablet	SCD	68d8b8d1-00a4-42c4-a796-90211fee1a6d	104
308047	ALPRAZolam 0.25 MG Oral Tablet	PSN	d2fd0b3e-9b78-44d0-82a6-96d6c6238750	10
308048	ALPRAZolam 0.5 MG Oral Tablet	PSN	d2fd0b3e-9b78-44d0-82a6-96d6c6238750	10
197321	ALPRAZolam 1 MG Oral Tablet	PSN	d2fd0b3e-9b78-44d0-82a6-96d6c6238750	10
197322	ALPRAZolam 2 MG Oral Tablet	PSN	d2fd0b3e-9b78-44d0-82a6-96d6c6238750	10
308047	alprazolam 0.25 MG Oral Tablet	SCD	d2fd0b3e-9b78-44d0-82a6-96d6c6238750	10
308048	alprazolam 0.5 MG Oral Tablet	SCD	d2fd0b3e-9b78-44d0-82a6-96d6c6238750	10
197321	alprazolam 1 MG Oral Tablet	SCD	d2fd0b3e-9b78-44d0-82a6-96d6c6238750	10
197322	alprazolam 2 MG Oral Tablet	SCD	d2fd0b3e-9b78-44d0-82a6-96d6c6238750	10
197322	ALPRAZolam 2 MG Oral Tablet	PSN	f9903822-642d-e364-e053-6394a90a22d8	3
197322	alprazolam 2 MG Oral Tablet	SCD	f9903822-642d-e364-e053-6394a90a22d8	3
197322	ALPRAZolam 2 MG Oral Tablet	PSN	f77cfdd0-847d-4edd-e053-6394a90a91b7	2
197322	alprazolam 2 MG Oral Tablet	SCD	f77cfdd0-847d-4edd-e053-6394a90a91b7	2
308047	ALPRAZolam 0.25 MG Oral Tablet	PSN	8d76a554-7ed1-4c93-a5ea-30898aec0aa1	1
308048	ALPRAZolam 0.5 MG Oral Tablet	PSN	8d76a554-7ed1-4c93-a5ea-30898aec0aa1	1
197321	ALPRAZolam 1 MG Oral Tablet	PSN	8d76a554-7ed1-4c93-a5ea-30898aec0aa1	1
197322	ALPRAZolam 2 MG Oral Tablet	PSN	1e198501-d8ea-45fc-e063-6294a90a132f	1
197322	ALPRAZolam 2 MG Oral Tablet	PSN	8d76a554-7ed1-4c93-a5ea-30898aec0aa1	1
197322	ALPRAZolam 2 MG Oral Tablet	PSN	1e1b6670-badf-a933-e063-6394a90a3a47	1
308047	alprazolam 0.25 MG Oral Tablet	SCD	8d76a554-7ed1-4c93-a5ea-30898aec0aa1	1
308048	alprazolam 0.5 MG Oral Tablet	SCD	8d76a554-7ed1-4c93-a5ea-30898aec0aa1	1
197321	alprazolam 1 MG Oral Tablet	SCD	8d76a554-7ed1-4c93-a5ea-30898aec0aa1	1
197322	alprazolam 2 MG Oral Tablet	SCD	8d76a554-7ed1-4c93-a5ea-30898aec0aa1	1
197322	alprazolam 2 MG Oral Tablet	SCD	1e1b6670-badf-a933-e063-6394a90a3a47	1
197322	alprazolam 2 MG Oral Tablet	SCD	1e198501-d8ea-45fc-e063-6294a90a132f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Status
65862-679-39	65862067939	3000 TABLET in 1 BAG (65862-679-39)	3000 tablet	31-JUL-15	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Alprazolam	Clinical Solutions Wholesale, LLC	2026-07-28	HUMAN PRESCRIPTION DRUG LABEL	1
Alprazolam	Bryant Ranch Prepack	2026-05-20	HUMAN PRESCRIPTION DRUG LABEL	104
Alprazolam	ASCLEMED USA INC. \| ASCLEMED USA INC. DBA ENOVACHEM	2026-04-30	HUMAN PRESCRIPTION DRUG LABEL	1
Alprazolam	Aurobindo Pharma Limited	2025-12-11	Human Prescription Drug Label	10
Alprazolam	Direct_Rx	2025-01-22	HUMAN PRESCRIPTION DRUG LABEL	2
Alprazolam	RedPharm Drug	2024-07-25	HUMAN PRESCRIPTION DRUG LABEL	1
Alprazolam	RedPharm Drug	2024-07-25	HUMAN PRESCRIPTION DRUG LABEL	1
Alprazolam	NuCare Pharmaceuticals,Inc.	2024-03-12	HUMAN PRESCRIPTION DRUG LABEL	3