Alprazolam

Product NDC
0228-4024
11-digit product format
002284024
Labeler code
0228
Product ID
0228-4024_38c5b407-25a1-48f5-960e-87ef637b644c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA078561
Marketing category
ANDA
Marketing start
2010-03-17
Substance
ALPRAZOLAM
Active strength
1 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
A078561-001ALPRAZOLAMALPRAZOLAM0.25MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-16
A078561-002ALPRAZOLAMALPRAZOLAM0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-16
A078561-003ALPRAZOLAMALPRAZOLAM1MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-16
A078561-004ALPRAZOLAMALPRAZOLAM2MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078561-001AB
A078561-002AB
A078561-003AB
A078561-004AB

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 UTC2026-02A078561-001ALPRAZOLAM0.25MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078561-002ALPRAZOLAM0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078561-003ALPRAZOLAM1MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078561-004ALPRAZOLAM2MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078561-001ALPRAZOLAM0.25MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078561-002ALPRAZOLAM0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078561-003ALPRAZOLAM1MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078561-004ALPRAZOLAM2MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A078561-001ALPRAZOLAM0.25MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078561-002ALPRAZOLAM0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078561-003ALPRAZOLAM1MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078561-004ALPRAZOLAM2MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078561-001ALPRAZOLAM0.25MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078561-002ALPRAZOLAM0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078561-003ALPRAZOLAM1MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078561-004ALPRAZOLAM2MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078561-001ALPRAZOLAM0.25MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078561-002ALPRAZOLAM0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078561-003ALPRAZOLAM1MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078561-004ALPRAZOLAM2MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078561-001ALPRAZOLAM0.25MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078561-002ALPRAZOLAM0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078561-003ALPRAZOLAM1MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078561-004ALPRAZOLAM2MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078561-001ALPRAZOLAM0.25MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078561-002ALPRAZOLAM0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078561-003ALPRAZOLAM1MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078561-004ALPRAZOLAM2MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078561-001ALPRAZOLAM0.25MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078561-002ALPRAZOLAM0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078561-003ALPRAZOLAM1MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078561-004ALPRAZOLAM2MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078561-001ALPRAZOLAM0.25MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078561-002ALPRAZOLAM0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078561-003ALPRAZOLAM1MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078561-004ALPRAZOLAM2MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078561-001ALPRAZOLAM0.25MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A078561-002ALPRAZOLAM0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A078561-003ALPRAZOLAM1MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A078561-004ALPRAZOLAM2MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-03-16d06236e962d9…

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 UTC2026-02A078561-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078561-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078561-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078561-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078561-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078561-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078561-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078561-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078561-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078561-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078561-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078561-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078561-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078561-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078561-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078561-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078561-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078561-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078561-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078561-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078561-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078561-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078561-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078561-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078561-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078561-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078561-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078561-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078561-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078561-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078561-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078561-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078561-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078561-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078561-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078561-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078561-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078561-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078561-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078561-004AB1d06236e962d9…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALPRAZOLAM1 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
485413Internal RxNorm lookup
485414Internal RxNorm lookup
485415Internal RxNorm lookup
485416Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5ceed721-2e65-4c81-bd84-f110b1ac9d2eAvailable 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
0228-4024-11Alprazolam100 in 1 BOTTLETABLET, ORALLY DISINTEGRATING10024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0228-4024-11EA - Each0228-4024dc2767d4-f658-4184-ba0e-4c0e524bd28f12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0228-4024ALPRAZOLAM TABLET, ORALLY DISINTEGRATING [ACTAVIS PHARMA, INC.]23Current NDC, Legacy NDC, 1 package rows20230131_5ceed721-2e65-4c81-bd84-f110b1ac9d2e.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AlprazolamALPRAZOLAMActavis Pharma, Inc.5ceed721-2e65-4c81-bd84-f110b1ac9d2e2022-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078561
application number: ANDA078561
ndc (product): 0228-4024

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485413ALPRAZolam 0.25 MG Disintegrating Oral TabletPSN5ceed721-2e65-4c81-bd84-f110b1ac9d2e24
485415ALPRAZolam 0.5 MG Disintegrating Oral TabletPSN5ceed721-2e65-4c81-bd84-f110b1ac9d2e24
485414ALPRAZolam 1 MG Disintegrating Oral TabletPSN5ceed721-2e65-4c81-bd84-f110b1ac9d2e24
485416ALPRAZolam 2 MG Disintegrating Oral TabletPSN5ceed721-2e65-4c81-bd84-f110b1ac9d2e24
485413alprazolam 0.25 MG Disintegrating Oral TabletSCD5ceed721-2e65-4c81-bd84-f110b1ac9d2e24
485415alprazolam 0.5 MG Disintegrating Oral TabletSCD5ceed721-2e65-4c81-bd84-f110b1ac9d2e24
485414alprazolam 1 MG Disintegrating Oral TabletSCD5ceed721-2e65-4c81-bd84-f110b1ac9d2e24
485416alprazolam 2 MG Disintegrating Oral TabletSCD5ceed721-2e65-4c81-bd84-f110b1ac9d2e24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0228-4024-1100228402411100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (0228-4024-11) 2010-03-170000-00-00NoNoCurrent