Alprazolam

Product NDC
59762-0068
11-digit product format
597620068
Labeler code
59762
Product ID
59762-0068_70f0098e-50b5-4e61-b4e0-141a55d92267
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
alprazolam
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
NDA021434
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2003-01-17
Substance
ALPRAZOLAM
Active strength
3 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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021434-001XANAX XRALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORALABRLD2003-01-17
N021434-002XANAX XRALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORALABRLD2003-01-17
N021434-003XANAX XRALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORALABRLD2003-01-17
N021434-004XANAX XRALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2003-01-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N021434-001AB
N021434-002AB
N021434-003AB
N021434-004AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021434-001XANAX XR0.5MGTABLET, EXTENDED RELEASE / ORALABRLD2003-01-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021434-002XANAX XR1MGTABLET, EXTENDED RELEASE / ORALABRLD2003-01-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021434-003XANAX XR2MGTABLET, EXTENDED RELEASE / ORALABRLD2003-01-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021434-004XANAX XR3MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2003-01-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021434-001XANAX XR0.5MGTABLET, EXTENDED RELEASE / ORALABRLD2003-01-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021434-002XANAX XR1MGTABLET, EXTENDED RELEASE / ORALABRLD2003-01-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021434-003XANAX XR2MGTABLET, EXTENDED RELEASE / ORALABRLD2003-01-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021434-004XANAX XR3MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2003-01-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N021434-001XANAX XR0.5MGTABLET, EXTENDED RELEASE / ORALABRLD2003-01-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021434-002XANAX XR1MGTABLET, EXTENDED RELEASE / ORALABRLD2003-01-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021434-003XANAX XR2MGTABLET, EXTENDED RELEASE / ORALABRLD2003-01-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021434-004XANAX XR3MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2003-01-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021434-001XANAX XR0.5MGTABLET, EXTENDED RELEASE / ORALABRLD2003-01-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021434-002XANAX XR1MGTABLET, EXTENDED RELEASE / ORALABRLD2003-01-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021434-003XANAX XR2MGTABLET, EXTENDED RELEASE / ORALABRLD2003-01-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021434-004XANAX XR3MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2003-01-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021434-001XANAX XR0.5MGTABLET, EXTENDED RELEASE / ORALABRLD2003-01-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021434-002XANAX XR1MGTABLET, EXTENDED RELEASE / ORALABRLD2003-01-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021434-003XANAX XR2MGTABLET, EXTENDED RELEASE / ORALABRLD2003-01-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021434-004XANAX XR3MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2003-01-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021434-001XANAX XR0.5MGTABLET, EXTENDED RELEASE / ORALABRLD2003-01-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021434-002XANAX XR1MGTABLET, EXTENDED RELEASE / ORALABRLD2003-01-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021434-003XANAX XR2MGTABLET, EXTENDED RELEASE / ORALABRLD2003-01-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021434-004XANAX XR3MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2003-01-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021434-001XANAX XR0.5MGTABLET, EXTENDED RELEASE / ORALABRLD2003-01-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021434-002XANAX XR1MGTABLET, EXTENDED RELEASE / ORALABRLD2003-01-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021434-003XANAX XR2MGTABLET, EXTENDED RELEASE / ORALABRLD2003-01-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021434-004XANAX XR3MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2003-01-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021434-001XANAX XR0.5MGTABLET, EXTENDED RELEASE / ORALABRLD2003-01-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021434-002XANAX XR1MGTABLET, EXTENDED RELEASE / ORALABRLD2003-01-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021434-003XANAX XR2MGTABLET, EXTENDED RELEASE / ORALABRLD2003-01-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021434-004XANAX XR3MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2003-01-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021434-001XANAX XR0.5MGTABLET, EXTENDED RELEASE / ORALABRLD2003-01-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021434-002XANAX XR1MGTABLET, EXTENDED RELEASE / ORALABRLD2003-01-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021434-003XANAX XR2MGTABLET, EXTENDED RELEASE / ORALABRLD2003-01-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021434-004XANAX XR3MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2003-01-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021434-001XANAX XR0.5MGTABLET, EXTENDED RELEASE / ORALABRLD2003-01-17d06236e962d9…
2024-10-29 15:01 UTC2024-10N021434-002XANAX XR1MGTABLET, EXTENDED RELEASE / ORALABRLD2003-01-17d06236e962d9…
2024-10-29 15:01 UTC2024-10N021434-003XANAX XR2MGTABLET, EXTENDED RELEASE / ORALABRLD2003-01-17d06236e962d9…
2024-10-29 15:01 UTC2024-10N021434-004XANAX XR3MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2003-01-17d06236e962d9…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N021434-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021434-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021434-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021434-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021434-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021434-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021434-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021434-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021434-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021434-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021434-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021434-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021434-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021434-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021434-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021434-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021434-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021434-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021434-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021434-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021434-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021434-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021434-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021434-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021434-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021434-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021434-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021434-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021434-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021434-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021434-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021434-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021434-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021434-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021434-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021434-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021434-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021434-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021434-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021434-004AB1d06236e962d9…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALPRAZOLAM3 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
YU55MQ3IZYInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
433798Internal RxNorm lookup
433799Internal RxNorm lookup
433800Internal RxNorm lookup
433801Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1338d1c9-7c75-42ed-95f3-9eb1b6fc51d3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2ffbe5ef-58ff-88b9-e291-045e0f861f4fProduct name420180827
1f9e6d58-49d3-d9c1-e570-4bb0466a2c0bProduct name120140508
a1a11520-f3e2-68fa-8bd9-e80b271ef797Product name120140508
d153678e-a3c8-bad8-cfe0-385656dde0e7Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59762-0068-1AlprazolamXR60 in 1 BOTTLETABLET, EXTENDED RELEASE6019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-0068-1EA - Each59762-006857a46791-4aef-4e03-b78e-be8632c62ecc12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-0068ALPRAZOLAM XR (ALPRAZOLAM) TABLET, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]19Current NDC, Legacy NDC, 1 package rows20250507_1338d1c9-7c75-42ed-95f3-9eb1b6fc51d3.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alprazolam XRALPRAZOLAMMylan Pharmaceuticals Inc.1338d1c9-7c75-42ed-95f3-9eb1b6fc51d32025-02-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021434
application number: NDA021434
ndc (product): 59762-0068
Xanax XRALPRAZOLAMViatris Specialty LLCc8990714-c2f5-4b0c-9f1c-91d77156d9622023-04-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021434
application number: NDA021434

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
433798ALPRAZolam 0.5 MG 24HR Extended Release Oral TabletPSN1338d1c9-7c75-42ed-95f3-9eb1b6fc51d319
433800ALPRAZolam 1 MG 24HR Extended Release Oral TabletPSN1338d1c9-7c75-42ed-95f3-9eb1b6fc51d319
433799ALPRAZolam 2 MG 24HR Extended Release Oral TabletPSN1338d1c9-7c75-42ed-95f3-9eb1b6fc51d319
433801ALPRAZolam 3 MG 24HR Extended Release Oral TabletPSN1338d1c9-7c75-42ed-95f3-9eb1b6fc51d319
43379824 HR alprazolam 0.5 MG Extended Release Oral TabletSCD1338d1c9-7c75-42ed-95f3-9eb1b6fc51d319
43380024 HR alprazolam 1 MG Extended Release Oral TabletSCD1338d1c9-7c75-42ed-95f3-9eb1b6fc51d319
43379924 HR alprazolam 2 MG Extended Release Oral TabletSCD1338d1c9-7c75-42ed-95f3-9eb1b6fc51d319
43380124 HR alprazolam 3 MG Extended Release Oral TabletSCD1338d1c9-7c75-42ed-95f3-9eb1b6fc51d319
433798alprazolam 0.5 MG 24 HR Extended Release Oral TabletSY1338d1c9-7c75-42ed-95f3-9eb1b6fc51d319
433800alprazolam 1 MG 24 HR Extended Release Oral TabletSY1338d1c9-7c75-42ed-95f3-9eb1b6fc51d319
433799alprazolam 2 MG 24 HR Extended Release Oral TabletSY1338d1c9-7c75-42ed-95f3-9eb1b6fc51d319
433801alprazolam 3 MG 24 HR Extended Release Oral TabletSY1338d1c9-7c75-42ed-95f3-9eb1b6fc51d319

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59762-0068-15976200680160 TABLET, EXTENDED RELEASE in 1 BOTTLE (59762-0068-1) 2003-01-170000-00-00NoNoCurrent