Xanax

Product NDC: 0009-0066
11-digit product format: 000090066
Labeler code: 0009
Product ID: 0009-0066_f364e489-b47b-4283-a7fe-d5b15f77447e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: alprazolam
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Pharmacia & Upjohn Company LLC
Application: NDA021434
Marketing category: NDA
Marketing start: 2003-01-17
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: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0009-0066		D	Discontinued by firm		2026-08-03
excluded package	package	0009-0066	0009-0066-07	D	Discontinued by firm		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 · 12 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0009-0066-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0009-0066-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0009-0066-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0009-0066-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0009-0066-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0009-0066-07	`cdf11ea48f46…`	`ba0047e9e063…`

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0009-0066-07	EA - Each	0009-0066	c26ae9d4-643d-469c-b18b-f79053accc2c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALPRAZOLAM	ACTIVE INGREDIENT	YU55MQ3IZY	XANAX XR (ALPRAZOLAM) TABLET, EXTENDED RELEASE [PHARMACIA AND UPJOHN COMPANY]	7
ALPRAZOLAM	ACTIVE MOIETY	YU55MQ3IZY	XANAX XR (ALPRAZOLAM) TABLET, EXTENDED RELEASE [PHARMACIA AND UPJOHN COMPANY]	7
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	XANAX XR (ALPRAZOLAM) TABLET, EXTENDED RELEASE [PHARMACIA AND UPJOHN COMPANY]	7
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	XANAX XR (ALPRAZOLAM) TABLET, EXTENDED RELEASE [PHARMACIA AND UPJOHN COMPANY]	7
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	XANAX XR (ALPRAZOLAM) TABLET, EXTENDED RELEASE [PHARMACIA AND UPJOHN COMPANY]	7
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	XANAX XR (ALPRAZOLAM) TABLET, EXTENDED RELEASE [PHARMACIA AND UPJOHN COMPANY]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	XANAX XR (ALPRAZOLAM) TABLET, EXTENDED RELEASE [PHARMACIA AND UPJOHN COMPANY]	7
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	XANAX XR (ALPRAZOLAM) TABLET, EXTENDED RELEASE [PHARMACIA AND UPJOHN COMPANY]	7

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

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
0009-0066-07	00009006607	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0009-0066-07)	2003-01-17	0000-00-00	No	No	Current