Alprazolam

Product NDC
68788-9682
Requested package NDC
68788-9682-9
11-digit product format
687889682
Labeler code
68788
Product ID
68788-9682_8c804e62-2699-4067-a5c4-fb917f853694
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA090871
Marketing category
ANDA
Marketing start
2013-04-22
Marketing end
0000-00-00
Substance
ALPRAZOLAM
Active strength
1 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68788-968268788-9682-9DDiscontinued by firm2026-08-10

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, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
A090871-001ALPRAZOLAMALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORALAB2011-06-07
A090871-002ALPRAZOLAMALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORALAB2011-06-07
A090871-003ALPRAZOLAMALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORALAB2011-06-07
A090871-004ALPRAZOLAMALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORALAB2011-06-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090871-001AB
A090871-002AB
A090871-003AB
A090871-004AB

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 UTC2026-02A090871-001ALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORALAB2011-06-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090871-002ALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORALAB2011-06-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090871-003ALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORALAB2011-06-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090871-004ALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORALAB2011-06-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090871-001ALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORALAB2011-06-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090871-002ALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORALAB2011-06-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090871-003ALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORALAB2011-06-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090871-004ALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORALAB2011-06-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A090871-001ALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORALAB2011-06-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090871-002ALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORALAB2011-06-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090871-003ALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORALAB2011-06-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090871-004ALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORALAB2011-06-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090871-001ALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORALAB2011-06-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090871-002ALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORALAB2011-06-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090871-003ALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORALAB2011-06-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090871-004ALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORALAB2011-06-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090871-001ALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORALAB2011-06-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090871-002ALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORALAB2011-06-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090871-003ALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORALAB2011-06-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090871-004ALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORALAB2011-06-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090871-001ALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORALAB2011-06-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090871-002ALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORALAB2011-06-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090871-003ALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORALAB2011-06-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090871-004ALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORALAB2011-06-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090871-001ALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORALAB2011-06-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090871-002ALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORALAB2011-06-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090871-003ALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORALAB2011-06-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090871-004ALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORALAB2011-06-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090871-001ALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORALAB2011-06-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090871-002ALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORALAB2011-06-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090871-003ALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORALAB2011-06-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090871-004ALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORALAB2011-06-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090871-001ALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORALAB2011-06-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090871-002ALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORALAB2011-06-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090871-003ALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORALAB2011-06-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090871-004ALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORALAB2011-06-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090871-001ALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORALAB2011-06-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A090871-002ALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORALAB2011-06-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A090871-003ALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORALAB2011-06-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A090871-004ALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORALAB2011-06-07d06236e962d9…

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 UTC2026-02A090871-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090871-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090871-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090871-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090871-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090871-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090871-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090871-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090871-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090871-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090871-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090871-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090871-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090871-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090871-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090871-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090871-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090871-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090871-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090871-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090871-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090871-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090871-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090871-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090871-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090871-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090871-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090871-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090871-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090871-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090871-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090871-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090871-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090871-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090871-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090871-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090871-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090871-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090871-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090871-004AB1d06236e962d9…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
68788-9682-32022-02-23These highlights do not include all the information needed to use ALPRAZOLAM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM EXTENDED-RELEASE TABLETS. ALPRAZOLAM extended-release tablets, for oral use, CIV Initial U.S. Approval: 1981
68788-9682-62022-02-23These highlights do not include all the information needed to use ALPRAZOLAM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM EXTENDED-RELEASE TABLETS. ALPRAZOLAM extended-release tablets, for oral use, CIV Initial U.S. Approval: 1981
68788-9682-92022-02-23These highlights do not include all the information needed to use ALPRAZOLAM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM EXTENDED-RELEASE TABLETS. ALPRAZOLAM extended-release tablets, for oral use, CIV Initial U.S. Approval: 1981
68788-9682-32022-01-28These highlights do not include all the information needed to use ALPRAZOLAM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM EXTENDED-RELEASE TABLETS. ALPRAZOLAM extended-release tablets, for oral use, CIV Initial U.S. Approval: 1981
68788-9682-62022-01-28These highlights do not include all the information needed to use ALPRAZOLAM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM EXTENDED-RELEASE TABLETS. ALPRAZOLAM extended-release tablets, for oral use, CIV Initial U.S. Approval: 1981
68788-9682-92022-01-28These highlights do not include all the information needed to use ALPRAZOLAM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM EXTENDED-RELEASE TABLETS. ALPRAZOLAM extended-release tablets, for oral use, CIV Initial U.S. Approval: 1981

DailyMed Socrata Ingredients#

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AlprazolamALPRAZOLAMBryant Ranch Prepackaaab422d-c763-4352-8ffc-5aafdf91e8dd2026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090871
application number: ANDA090871
AlprazolamALPRAZOLAMBryant Ranch Prepack0dce8232-0b0e-4f81-af95-36e6febdb5502026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090871
application number: ANDA090871
AlprazolamALPRAZOLAMAurobindo Pharma Limited326fa31a-5420-429b-9f7f-170cb38f64bd2025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090871
application number: ANDA090871
AlprazolamALPRAZOLAMAsclemed USA, Inc.5d839a8b-0f45-42bf-acc1-2bd28f948e532024-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090871
application number: ANDA090871
AlprazolamALPRAZOLAMProficient Rx LP34631dbf-f817-484d-8bcf-f8efa07178d72021-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090871
application number: ANDA090871
AlprazolamALPRAZOLAMProficient Rx LP969acb29-3b5c-47ed-8f7d-a960a24e72e32021-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090871
application number: ANDA090871

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-9682-96878896820990 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-9682-9) 2013-04-220000-00-00NoNoCurrent