Xanax

Product NDC: 58151-503
11-digit product format: 581510503
Labeler code: 58151
Product ID: 58151-503_d8ad22b9-9ba3-4193-a678-23d5563d9511
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: alprazolam
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Viatris Specialty LLC
Application: NDA021434
Marketing category: NDA
Marketing start: 2024-05-21
Marketing end: 2026-08-31
Substance: ALPRAZOLAM
Active strength: .5 mg/1
Pharmacologic classes: Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
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
N021434-001	XANAX XR	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17
N021434-002	XANAX XR	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17
N021434-003	XANAX XR	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17
N021434-004	XANAX XR	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-01-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021434-001	AB
N021434-002	AB
N021434-003	AB
N021434-004	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	N021434-001	XANAX XR	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021434-002	XANAX XR	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021434-003	XANAX XR	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021434-004	XANAX XR	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-01-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021434-001	XANAX XR	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021434-002	XANAX XR	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021434-003	XANAX XR	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021434-004	XANAX XR	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-01-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021434-001	XANAX XR	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021434-002	XANAX XR	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021434-003	XANAX XR	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021434-004	XANAX XR	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-01-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021434-001	XANAX XR	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021434-002	XANAX XR	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021434-003	XANAX XR	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021434-004	XANAX XR	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-01-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021434-001	XANAX XR	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021434-002	XANAX XR	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021434-003	XANAX XR	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021434-004	XANAX XR	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-01-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021434-001	XANAX XR	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021434-002	XANAX XR	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021434-003	XANAX XR	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021434-004	XANAX XR	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-01-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021434-001	XANAX XR	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021434-002	XANAX XR	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021434-003	XANAX XR	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021434-004	XANAX XR	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-01-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021434-001	XANAX XR	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021434-002	XANAX XR	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021434-003	XANAX XR	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021434-004	XANAX XR	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-01-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021434-001	XANAX XR	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021434-002	XANAX XR	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021434-003	XANAX XR	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021434-004	XANAX XR	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-01-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021434-001	XANAX XR	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021434-002	XANAX XR	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021434-003	XANAX XR	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021434-004	XANAX XR	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-01-17	`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	N021434-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021434-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021434-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021434-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021434-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021434-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021434-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021434-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021434-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021434-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021434-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021434-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021434-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021434-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021434-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021434-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021434-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021434-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021434-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021434-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021434-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021434-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021434-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021434-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021434-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021434-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021434-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021434-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021434-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021434-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021434-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021434-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021434-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021434-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021434-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021434-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021434-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021434-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021434-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021434-004	AB	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Xanax
Brand name suffix: XR

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
433798	Internal RxNorm lookup
433799	Internal RxNorm lookup
433800	Internal RxNorm lookup
433801	Internal RxNorm lookup
687022	Internal RxNorm lookup
687023	Internal RxNorm lookup
687024	Internal RxNorm lookup
687025	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
c8990714-c2f5-4b0c-9f1c-91d77156d962	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
58151-503-91	XanaxXR	60 in 1 BOTTLE	TABLET, EXTENDED RELEASE	60		25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58151-503-91	EA - Each	58151-503	7b2e6431-eda2-441f-8923-bab04224aae7	1	2024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58151-503	XANAX XR (ALPRAZOLAM) TABLET, EXTENDED RELEASE [VIATRIS SPECIALTY LLC]	23	Current NDC, 1 package rows	20240806_c8990714-c2f5-4b0c-9f1c-91d77156d962.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alprazolam XR	ALPRAZOLAM	Mylan Pharmaceuticals Inc.	1338d1c9-7c75-42ed-95f3-9eb1b6fc51d3	2025-02-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021434 application number: NDA021434
Xanax XR	ALPRAZOLAM	Viatris Specialty LLC	c8990714-c2f5-4b0c-9f1c-91d77156d962	2023-04-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021434 application number: NDA021434 ndc (product): 58151-503

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
YU55MQ3IZY	ALPRAZOLAM	28981-97-7	ALPRAZOLAM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
58151-503-91	58151050391	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (58151-503-91)	2024-05-21	2026-08-31	No	No	Historical