Xanax

Product NDC: 58151-453
11-digit product format: 581510453
Labeler code: 58151
Product ID: 58151-453_27062ff4-9ce3-4d8a-aeae-f4468efb623a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: alprazolam
Dosage form: TABLET
Route: ORAL
Labeler: Viatris Specialty LLC
Application: NDA018276
Marketing category: NDA
Marketing start: 2025-07-10
Substance: ALPRAZOLAM
Active strength: .5 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

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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALPRAZOLAM	.5 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 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
141927	Internal RxNorm lookup
141928	Internal RxNorm lookup
197321	Internal RxNorm lookup
197322	Internal RxNorm lookup
214003	Internal RxNorm lookup
214004	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
bb5cf72e-3a41-41a8-9a38-80f974eca33f	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58151-453-01	Xanax	100 in 1 BOTTLE	TABLET	100		4
58151-453-05	Xanax	500 in 1 BOTTLE	TABLET	500		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58151-453-01	EA - Each	58151-453	95959bf1-539e-4ef0-9cbb-350f61845526	1	2025-08-11
58151-453-05	EA - Each	58151-453	a5644b33-09ca-4d48-9dfd-128d5f4d94ff	1	2025-11-13

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 ndc (product): 58151-453
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
308047	ALPRAZolam 0.25 MG Oral Tablet	PSN	bb5cf72e-3a41-41a8-9a38-80f974eca33f	4
308048	ALPRAZolam 0.5 MG Oral Tablet	PSN	bb5cf72e-3a41-41a8-9a38-80f974eca33f	4
197321	ALPRAZolam 1 MG Oral Tablet	PSN	bb5cf72e-3a41-41a8-9a38-80f974eca33f	4
197322	ALPRAZolam 2 MG Oral Tablet	PSN	bb5cf72e-3a41-41a8-9a38-80f974eca33f	4
141927	Xanax 0.25 MG Oral Tablet	PSN	bb5cf72e-3a41-41a8-9a38-80f974eca33f	4
141928	Xanax 0.5 MG Oral Tablet	PSN	bb5cf72e-3a41-41a8-9a38-80f974eca33f	4
214003	Xanax 1 MG Oral Tablet	PSN	bb5cf72e-3a41-41a8-9a38-80f974eca33f	4
214004	Xanax 2 MG Oral Tablet	PSN	bb5cf72e-3a41-41a8-9a38-80f974eca33f	4
141927	alprazolam 0.25 MG Oral Tablet [Xanax]	SBD	bb5cf72e-3a41-41a8-9a38-80f974eca33f	4
141928	alprazolam 0.5 MG Oral Tablet [Xanax]	SBD	bb5cf72e-3a41-41a8-9a38-80f974eca33f	4
214003	alprazolam 1 MG Oral Tablet [Xanax]	SBD	bb5cf72e-3a41-41a8-9a38-80f974eca33f	4
214004	alprazolam 2 MG Oral Tablet [Xanax]	SBD	bb5cf72e-3a41-41a8-9a38-80f974eca33f	4
308047	alprazolam 0.25 MG Oral Tablet	SCD	bb5cf72e-3a41-41a8-9a38-80f974eca33f	4
308048	alprazolam 0.5 MG Oral Tablet	SCD	bb5cf72e-3a41-41a8-9a38-80f974eca33f	4
197321	alprazolam 1 MG Oral Tablet	SCD	bb5cf72e-3a41-41a8-9a38-80f974eca33f	4
197322	alprazolam 2 MG Oral Tablet	SCD	bb5cf72e-3a41-41a8-9a38-80f974eca33f	4
141927	Xanax 0.25 MG Oral Tablet	SY	bb5cf72e-3a41-41a8-9a38-80f974eca33f	4
141928	Xanax 0.5 MG Oral Tablet	SY	bb5cf72e-3a41-41a8-9a38-80f974eca33f	4
214003	Xanax 1 MG Oral Tablet	SY	bb5cf72e-3a41-41a8-9a38-80f974eca33f	4
214004	Xanax 2 MG Oral Tablet	SY	bb5cf72e-3a41-41a8-9a38-80f974eca33f	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
58151-453-01	58151045301	100 TABLET in 1 BOTTLE (58151-453-01)	100 tablet	2025-07-10	No	No	Current
58151-453-05	58151045305	500 TABLET in 1 BOTTLE (58151-453-05)	500 tablet	2025-10-02	No	No	Current