Alprazolam

Product NDC
0228-3083
11-digit product format
002283083
Labeler code
0228
Product ID
0228-3083_e89f9f55-9cd1-4b9d-b0a0-2d0480dd559c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA078056
Marketing category
ANDA
Marketing start
2007-03-12
Marketing end
2026-06-30
Substance
ALPRAZOLAM
Active strength
.5 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Current FDA listing
Yes

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0228-3083DDiscontinued by firm2026-08-17
excluded packagepackage0228-30830228-3083-06DDiscontinued by firm2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A078056-001ALPRAZOLAMALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORALAB2007-02-13
A078056-002ALPRAZOLAMALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORALAB2007-02-13
A078056-003ALPRAZOLAMALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORALAB2007-02-13
A078056-004ALPRAZOLAMALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORALAB2007-02-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078056-001AB
A078056-002AB
A078056-003AB
A078056-004AB

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078056-001ALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORALAB2007-02-13caaa826d4ba7…
2026-08-18 06:07:402026-07A078056-002ALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORALAB2007-02-13caaa826d4ba7…
2026-08-18 06:07:402026-07A078056-003ALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORALAB2007-02-13caaa826d4ba7…
2026-08-18 06:07:402026-07A078056-004ALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORALAB2007-02-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078056-001ALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORALAB2007-02-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078056-002ALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORALAB2007-02-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078056-003ALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORALAB2007-02-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078056-004ALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORALAB2007-02-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078056-001ALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORALAB2007-02-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078056-002ALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORALAB2007-02-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078056-003ALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORALAB2007-02-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078056-004ALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORALAB2007-02-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A078056-001ALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORALAB2007-02-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078056-002ALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORALAB2007-02-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078056-003ALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORALAB2007-02-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078056-004ALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORALAB2007-02-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078056-001ALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORALAB2007-02-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078056-002ALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORALAB2007-02-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078056-003ALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORALAB2007-02-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078056-004ALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORALAB2007-02-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078056-001ALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORALAB2007-02-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078056-002ALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORALAB2007-02-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078056-003ALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORALAB2007-02-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078056-004ALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORALAB2007-02-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078056-001ALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORALAB2007-02-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078056-002ALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORALAB2007-02-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078056-003ALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORALAB2007-02-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078056-004ALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORALAB2007-02-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078056-001ALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORALAB2007-02-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078056-002ALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORALAB2007-02-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078056-003ALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORALAB2007-02-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078056-004ALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORALAB2007-02-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078056-001ALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORALAB2007-02-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078056-002ALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORALAB2007-02-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078056-003ALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORALAB2007-02-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078056-004ALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORALAB2007-02-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078056-001ALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORALAB2007-02-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078056-002ALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORALAB2007-02-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078056-003ALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORALAB2007-02-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078056-004ALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORALAB2007-02-13d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A078056-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078056-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078056-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078056-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078056-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078056-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078056-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078056-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078056-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078056-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078056-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078056-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078056-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078056-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078056-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078056-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078056-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078056-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078056-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078056-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078056-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078056-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078056-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078056-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078056-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078056-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078056-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078056-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078056-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078056-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078056-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078056-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078056-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078056-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078056-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078056-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078056-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078056-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078056-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078056-004AB1d8e5a09893c0…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
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
0228-3083-06AlprazolamExtended Release60 in 1 BOTTLETABLET, EXTENDED RELEASE6016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0228-3083-06EA - Each0228-308323ad39fb-e769-4145-a5fa-7fbb4546e48612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM EXTENDED RELEASE (ALPRAZOLAM) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM EXTENDED RELEASE (ALPRAZOLAM) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOALPRAZOLAM EXTENDED RELEASE (ALPRAZOLAM) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM EXTENDED RELEASE (ALPRAZOLAM) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM EXTENDED RELEASE (ALPRAZOLAM) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM EXTENDED RELEASE (ALPRAZOLAM) TABLET, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]4
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM EXTENDED RELEASE (ALPRAZOLAM) TABLET, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GALPRAZOLAM EXTENDED RELEASE (ALPRAZOLAM) TABLET, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKALPRAZOLAM EXTENDED RELEASE (ALPRAZOLAM) TABLET, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALPRAZOLAM EXTENDED RELEASE (ALPRAZOLAM) TABLET, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOALPRAZOLAM EXTENDED RELEASE (ALPRAZOLAM) TABLET, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM EXTENDED RELEASE (ALPRAZOLAM) TABLET, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM EXTENDED RELEASE (ALPRAZOLAM) TABLET, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0228-3083ALPRAZOLAM EXTENDED RELEASE (ALPRAZOLAM) TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]15Current NDC, Legacy NDC, 1 package rows20250326_a64496be-bf43-4ba9-a4b1-bd632965c1a0.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 Extended ReleaseALPRAZOLAMBryant Ranch Prepack29477df1-68aa-44b3-bf9e-80ecff6ce8792024-05-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078056
application number: ANDA078056
Alprazolam Extended ReleaseALPRAZOLAMBryant Ranch Prepack4f6e4656-689f-46a6-a8ed-54ee555833572023-05-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078056
application number: ANDA078056

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
433798ALPRAZolam 0.5 MG 24HR Extended Release Oral TabletPSN29477df1-68aa-44b3-bf9e-80ecff6ce879101
43379824 HR alprazolam 0.5 MG Extended Release Oral TabletSCD29477df1-68aa-44b3-bf9e-80ecff6ce879101
433798alprazolam 0.5 MG 24 HR Extended Release Oral TabletSY29477df1-68aa-44b3-bf9e-80ecff6ce879101
433798ALPRAZolam 0.5 MG 24HR Extended Release Oral TabletPSN4f6e4656-689f-46a6-a8ed-54ee55583357100
43379824 HR alprazolam 0.5 MG Extended Release Oral TabletSCD4f6e4656-689f-46a6-a8ed-54ee55583357100
433798alprazolam 0.5 MG 24 HR Extended Release Oral TabletSY4f6e4656-689f-46a6-a8ed-54ee55583357100
433798ALPRAZolam 0.5 MG 24HR Extended Release Oral TabletPSNa64496be-bf43-4ba9-a4b1-bd632965c1a016
433800ALPRAZolam 1 MG 24HR Extended Release Oral TabletPSNa64496be-bf43-4ba9-a4b1-bd632965c1a016
433799ALPRAZolam 2 MG 24HR Extended Release Oral TabletPSNa64496be-bf43-4ba9-a4b1-bd632965c1a016
433801ALPRAZolam 3 MG 24HR Extended Release Oral TabletPSNa64496be-bf43-4ba9-a4b1-bd632965c1a016
43379824 HR alprazolam 0.5 MG Extended Release Oral TabletSCDa64496be-bf43-4ba9-a4b1-bd632965c1a016
43380024 HR alprazolam 1 MG Extended Release Oral TabletSCDa64496be-bf43-4ba9-a4b1-bd632965c1a016
43379924 HR alprazolam 2 MG Extended Release Oral TabletSCDa64496be-bf43-4ba9-a4b1-bd632965c1a016
43380124 HR alprazolam 3 MG Extended Release Oral TabletSCDa64496be-bf43-4ba9-a4b1-bd632965c1a016
433798alprazolam 0.5 MG 24 HR Extended Release Oral TabletSYa64496be-bf43-4ba9-a4b1-bd632965c1a016
433800alprazolam 1 MG 24 HR Extended Release Oral TabletSYa64496be-bf43-4ba9-a4b1-bd632965c1a016
433799alprazolam 2 MG 24 HR Extended Release Oral TabletSYa64496be-bf43-4ba9-a4b1-bd632965c1a016
433801alprazolam 3 MG 24 HR Extended Release Oral TabletSYa64496be-bf43-4ba9-a4b1-bd632965c1a016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0228-3083-060022830830660 TABLET, EXTENDED RELEASE in 1 BOTTLE (0228-3083-06) 2007-03-122026-06-30NoNoCurrent