Alprazolam

Product NDC: 53002-0340
11-digit product format: 530020340
Labeler code: 53002
Product ID: 53002-0340_d0a9dd87-1579-4ebd-97b5-e1ea62d95f97
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: alprazolam
Dosage form: TABLET
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: NDA018276
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 1981-10-16
Marketing end: 0000-00-00
Substance: ALPRAZOLAM
Active strength: 2 mg/1
Pharmacologic classes: Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2021-12-31
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	53002-0340		I	Inactivated by FDA	2026-08-03
excluded package	package	53002-0340	53002-0340-2	I	Inactivated by FDA	2026-08-03
excluded package	package	53002-0340	53002-0340-3	I	Inactivated by FDA	2026-08-03

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 · 33 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	53002-0340-2	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-0340-3	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	53002-0340-2	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-0340-3	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	53002-0340-2	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-0340-3	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	53002-0340-2	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-0340-3	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	53002-0340-2	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-0340-3	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	53002-0340-2	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-0340-3	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	53002-0340-2	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-0340-3	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	53002-0340-2	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-0340-3	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	53002-0340-2	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-0340-3	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53002-0340-2	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53002-0340-3	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53002-0340-3	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53002-0340-2	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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	TE codes	RLD / RS	Approval date
N018276-001	XANAX	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	RLD, Approved before 1982
N018276-002	XANAX	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982
N018276-003	XANAX	ALPRAZOLAM	1MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982
N018276-004	XANAX	ALPRAZOLAM	2MG	TABLET / ORAL	AB	RLD	1985-11-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018276-001	AB
N018276-002	AB
N018276-003	AB
N018276-004	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 · 164 observed 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
2026-02-19 14:30 UTC	2026-02	N018276-001	XANAX	0.25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018276-002	XANAX	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018276-003	XANAX	1MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018276-004	XANAX	2MG	TABLET / ORAL	AB	RLD	1985-11-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018276-001	XANAX	0.25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018276-002	XANAX	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018276-003	XANAX	1MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018276-004	XANAX	2MG	TABLET / ORAL	AB	RLD	1985-11-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018276-001	XANAX	0.25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018276-002	XANAX	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018276-003	XANAX	1MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018276-004	XANAX	2MG	TABLET / ORAL	AB	RLD	1985-11-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018276-001	XANAX	0.25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018276-002	XANAX	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018276-003	XANAX	1MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018276-004	XANAX	2MG	TABLET / ORAL	AB	RLD	1985-11-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018276-001	XANAX	0.25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018276-002	XANAX	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018276-003	XANAX	1MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018276-004	XANAX	2MG	TABLET / ORAL	AB	RLD	1985-11-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018276-001	XANAX	0.25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018276-002	XANAX	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018276-003	XANAX	1MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018276-004	XANAX	2MG	TABLET / ORAL	AB	RLD	1985-11-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018276-001	XANAX	0.25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018276-002	XANAX	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018276-003	XANAX	1MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018276-004	XANAX	2MG	TABLET / ORAL	AB	RLD	1985-11-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018276-001	XANAX	0.25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018276-002	XANAX	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018276-003	XANAX	1MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018276-004	XANAX	2MG	TABLET / ORAL	AB	RLD	1985-11-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018276-001	XANAX	0.25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018276-002	XANAX	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018276-003	XANAX	1MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018276-004	XANAX	2MG	TABLET / ORAL	AB	RLD	1985-11-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018276-001	XANAX	0.25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018276-002	XANAX	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018276-003	XANAX	1MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018276-004	XANAX	2MG	TABLET / ORAL	AB	RLD	1985-11-27	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018276-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018276-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018276-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018276-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018276-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018276-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018276-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018276-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018276-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018276-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018276-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018276-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018276-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018276-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018276-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018276-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018276-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018276-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018276-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018276-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018276-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018276-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018276-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018276-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018276-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018276-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018276-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018276-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018276-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018276-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018276-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018276-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018276-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018276-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018276-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018276-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018276-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018276-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018276-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018276-004	AB	1	`d06236e962d9…`

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, Related label table
NDC	Effective	Related label
53002-0340-2	2025-01-30	These highlights do not include all the information needed to use ALPRAZOLAM safely and effectively. See full prescribing information for ALPRAZOLAM. ALPRAZOLAM (alprazolam) tablets, for oral use, CIV Initial U.S. Approval: 1981
53002-0340-3	2025-01-30	These highlights do not include all the information needed to use ALPRAZOLAM safely and effectively. See full prescribing information for ALPRAZOLAM. ALPRAZOLAM (alprazolam) tablets, for oral use, CIV Initial U.S. Approval: 1981
53002-0340-2	2023-06-07	These highlights do not include all the information needed to use ALPRAZOLAM safely and effectively. See full prescribing information for ALPRAZOLAM. ALPRAZOLAM (alprazolam) tablets, for oral use, CIV Initial U.S. Approval: 1981
53002-0340-3	2023-06-07	These highlights do not include all the information needed to use ALPRAZOLAM safely and effectively. See full prescribing information for ALPRAZOLAM. ALPRAZOLAM (alprazolam) tablets, for oral use, CIV Initial U.S. Approval: 1981
53002-0340-2	2023-01-30	These highlights do not include all the information needed to use ALPRAZOLAM safely and effectively. See full prescribing information for ALPRAZOLAM. ALPRAZOLAM (alprazolam) tablets, for oral use, CIV Initial U.S. Approval: 1981
53002-0340-3	2023-01-30	These highlights do not include all the information needed to use ALPRAZOLAM safely and effectively. See full prescribing information for ALPRAZOLAM. ALPRAZOLAM (alprazolam) tablets, for oral use, CIV Initial U.S. Approval: 1981
53002-0340-2	2020-12-16	These highlights do not include all the information needed to use ALPRAZOLAM safely and effectively. See full prescribing information for ALPRAZOLAM. ALPRAZOLAM (alprazolam) tablets, for oral use, CIV Initial U.S. Approval: 1981
53002-0340-3	2020-12-16	These highlights do not include all the information needed to use ALPRAZOLAM safely and effectively. See full prescribing information for ALPRAZOLAM. ALPRAZOLAM (alprazolam) tablets, for oral use, CIV Initial U.S. Approval: 1981
53002-0340-2	2020-01-31	These highlights do not include all the information needed to use ALPRAZOLAM safely and effectively. See full prescribing information for ALPRAZOLAM. ALPRAZOLAM (alprazolam) tablets, for oral use, CIV Initial U.S. Approval: 1981
53002-0340-3	2020-01-31	These highlights do not include all the information needed to use ALPRAZOLAM safely and effectively. See full prescribing information for ALPRAZOLAM. ALPRAZOLAM (alprazolam) tablets, for oral use, CIV Initial U.S. Approval: 1981

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53002-0340-2	Alprazolam	20 in 1 BOTTLE	TABLET	20		5
53002-0340-3	Alprazolam	30 in 1 BOTTLE	TABLET	30		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-0340	ALPRAZOLAM TABLET [RPK PHARMACEUTICALS, INC.]	5	Legacy NDC, 2 package rows	20230609_88de14a4-e8a5-49bd-a480-b19fefbac15c.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 1 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alprazolam	ALPRAZOLAM	Mylan Pharmaceuticals Inc.	13930c94-d83a-414f-be35-b1fef35f738d	2025-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018276 application number: NDA018276
Xanax	ALPRAZOLAM	Viatris Specialty LLC	bb5cf72e-3a41-41a8-9a38-80f974eca33f	2024-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018276 application number: NDA018276
Alprazolam	ALPRAZOLAM	Asclemed USA, Inc.	e3245259-024f-4bd9-9ec6-94aa11febfd7	2024-01-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018276 application number: NDA018276
Alprazolam	ALPRAZOLAM	Proficient Rx LP	60c90b4b-174f-4fd2-b65f-fc166c16bdc1	2023-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018276 application number: NDA018276
Alprazolam	ALPRAZOLAM	Proficient Rx LP	10de2b3b-3b3f-4a5a-a9e7-a8401f53b8cc	2023-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018276 application number: NDA018276
Xanax	ALPRAZOLAM	PHARMACIA & UPJOHN COMPANY LLC	388e249d-b9b6-44c3-9f8f-880eced0239f	2023-01-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018276 application number: NDA018276
Alprazolam	ALPRAZOLAM	Proficient Rx LP	4579facb-b225-4108-a5ef-dada926ef7cf	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018276 application number: NDA018276
Alprazolam	ALPRAZOLAM	Proficient Rx LP	f6990b57-7011-4cdf-8abc-1794e2e0c7f1	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018276 application number: NDA018276
Alprazolam	ALPRAZOLAM	Aphena Pharma Solutions - Tennessee, LLC	964d7f43-34a6-45af-a95f-3b9ade17c6a5	2018-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018276 application number: NDA018276

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	88de14a4-e8a5-49bd-a480-b19fefbac15c	5
197322	alprazolam 2 MG Oral Tablet	SCD	88de14a4-e8a5-49bd-a480-b19fefbac15c	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-0340-2	53002034002	20 TABLET in 1 BOTTLE (53002-0340-2)	20 tablet	2017-10-01	0000-00-00	No	No	Current
53002-0340-3	53002034003	30 TABLET in 1 BOTTLE (53002-0340-3)	30 tablet	2017-10-01	0000-00-00	No	No	Current