ALPRAZOLAM

Product NDC
72189-029
Requested package NDC
72189-029-60
11-digit product format
721890029
Labeler code
72189
Product ID
72189-029_91d3dd5d-9b81-5d32-e053-2995a90a8096
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ALPRAZOLAM
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA090871
Marketing category
ANDA
Marketing start
2019-09-05
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
2020-12-31
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 packagepackage72189-02972189-029-60IInactivated by FDA2026-08-11

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 · 15 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…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72189-029-302023-01-30C16284748780-1f386c64a-319f-0266-e053-dadaa90a7c1aALPRAZOLAM
72189-029-602023-01-30C16284748780-1f386c64a-41bb-0266-e053-dadaa90a7c1aALPRAZOLAM
72189-029-902023-01-30C16284748780-1f386c649-a07a-0266-e053-dadaa90a7c1aALPRAZOLAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-029-30ALPRAZOLAM30 in 1 BOTTLETABLET, EXTENDED RELEASE301
72189-029-60ALPRAZOLAM60 in 1 BOTTLETABLET, EXTENDED RELEASE601
72189-029-90ALPRAZOLAM90 in 1 BOTTLETABLET, EXTENDED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-029-30EA - Each72189-029c469bff1-9df1-4e55-ae60-faad54ab3edb12019-10-07
72189-029-60EA - Each72189-029dfd38a09-b0a7-459a-a5b2-f24daff2797712019-10-07
72189-029-90EA - Each72189-02966dc37ea-0f39-4831-a5f2-7f3c6f2decb812019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-029ALPRAZOLAM TABLET, EXTENDED RELEASE [DIRECT_RX]1Legacy NDC, 1 package rows20190907_91d3dd5d-9b80-5d32-e053-2995a90a8096.zip
72189-029ALPRAZOLAM TABLET, EXTENDED RELEASE [DIRECT_RX]1Legacy NDC, 1 package rows20190907_91d4bc67-31a7-bd2e-e053-2a95a90a8632.zip
72189-029ALPRAZOLAM TABLET, EXTENDED RELEASE [DIRECT_RX]1Legacy NDC, 1 package rows20190907_91e22909-eebc-e3ae-e053-2a95a90a3e94.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 · 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
433800ALPRAZolam 1 MG 24HR Extended Release Oral TabletPSN91d3dd5d-9b80-5d32-e053-2995a90a80961
433800ALPRAZolam 1 MG 24HR Extended Release Oral TabletPSN91d4bc67-31a7-bd2e-e053-2a95a90a86321
433800ALPRAZolam 1 MG 24HR Extended Release Oral TabletPSN91e22909-eebc-e3ae-e053-2a95a90a3e941
43380024 HR alprazolam 1 MG Extended Release Oral TabletSCD91d3dd5d-9b80-5d32-e053-2995a90a80961
43380024 HR alprazolam 1 MG Extended Release Oral TabletSCD91d4bc67-31a7-bd2e-e053-2a95a90a86321
43380024 HR alprazolam 1 MG Extended Release Oral TabletSCD91e22909-eebc-e3ae-e053-2a95a90a3e941
433800alprazolam 1 MG 24 HR Extended Release Oral TabletSY91d3dd5d-9b80-5d32-e053-2995a90a80961
433800alprazolam 1 MG 24 HR Extended Release Oral TabletSY91d4bc67-31a7-bd2e-e053-2a95a90a86321
433800alprazolam 1 MG 24 HR Extended Release Oral TabletSY91e22909-eebc-e3ae-e053-2a95a90a3e941

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-029-607218900296060 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-029-60) 2019-09-060000-00-00NoNoCurrent