Alprazolam

Product NDC
50090-5109
11-digit product format
500905109
Labeler code
50090
Product ID
50090-5109_0caddd71-10b0-4510-a0ce-f18c7cc4b4be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA074342
Marketing category
ANDA
Marketing start
1993-10-01
Marketing end
0000-00-00
Substance
ALPRAZOLAM
Active strength
0 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-5109IInactivated by FDA2026-08-07
excluded packagepackage50090-510950090-5109-0IInactivated by FDA2026-08-07

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 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-5109-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-5109-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-5109-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-5109-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-5109-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-5109-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-5109-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-5109-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-5109-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-5109-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-5109-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-5109-0557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-5109-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-5109-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-5109-01332a3947898…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
A074342-001ALPRAZOLAMALPRAZOLAM0.25MGTABLET / ORALAB1993-10-31
A074342-002ALPRAZOLAMALPRAZOLAM0.5MGTABLET / ORALAB1993-10-31
A074342-003ALPRAZOLAMALPRAZOLAM1MGTABLET / ORALAB1993-10-31
A074342-004ALPRAZOLAMALPRAZOLAM2MGTABLET / ORALAB1993-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074342-001AB
A074342-002AB
A074342-003AB
A074342-004AB

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 UTC2026-02A074342-001ALPRAZOLAM0.25MGTABLET / ORALAB1993-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074342-002ALPRAZOLAM0.5MGTABLET / ORALAB1993-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074342-003ALPRAZOLAM1MGTABLET / ORALAB1993-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074342-004ALPRAZOLAM2MGTABLET / ORALAB1993-10-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074342-001ALPRAZOLAM0.25MGTABLET / ORALAB1993-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074342-002ALPRAZOLAM0.5MGTABLET / ORALAB1993-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074342-003ALPRAZOLAM1MGTABLET / ORALAB1993-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074342-004ALPRAZOLAM2MGTABLET / ORALAB1993-10-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074342-001ALPRAZOLAM0.25MGTABLET / ORALAB1993-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074342-002ALPRAZOLAM0.5MGTABLET / ORALAB1993-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074342-003ALPRAZOLAM1MGTABLET / ORALAB1993-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074342-004ALPRAZOLAM2MGTABLET / ORALAB1993-10-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074342-001ALPRAZOLAM0.25MGTABLET / ORALAB1993-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074342-002ALPRAZOLAM0.5MGTABLET / ORALAB1993-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074342-003ALPRAZOLAM1MGTABLET / ORALAB1993-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074342-004ALPRAZOLAM2MGTABLET / ORALAB1993-10-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074342-001ALPRAZOLAM0.25MGTABLET / ORALAB1993-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074342-002ALPRAZOLAM0.5MGTABLET / ORALAB1993-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074342-003ALPRAZOLAM1MGTABLET / ORALAB1993-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074342-004ALPRAZOLAM2MGTABLET / ORALAB1993-10-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074342-001ALPRAZOLAM0.25MGTABLET / ORALAB1993-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074342-002ALPRAZOLAM0.5MGTABLET / ORALAB1993-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074342-003ALPRAZOLAM1MGTABLET / ORALAB1993-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074342-004ALPRAZOLAM2MGTABLET / ORALAB1993-10-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074342-001ALPRAZOLAM0.25MGTABLET / ORALAB1993-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074342-002ALPRAZOLAM0.5MGTABLET / ORALAB1993-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074342-003ALPRAZOLAM1MGTABLET / ORALAB1993-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074342-004ALPRAZOLAM2MGTABLET / ORALAB1993-10-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074342-001ALPRAZOLAM0.25MGTABLET / ORALAB1993-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074342-002ALPRAZOLAM0.5MGTABLET / ORALAB1993-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074342-003ALPRAZOLAM1MGTABLET / ORALAB1993-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074342-004ALPRAZOLAM2MGTABLET / ORALAB1993-10-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074342-001ALPRAZOLAM0.25MGTABLET / ORALAB1993-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074342-002ALPRAZOLAM0.5MGTABLET / ORALAB1993-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074342-003ALPRAZOLAM1MGTABLET / ORALAB1993-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074342-004ALPRAZOLAM2MGTABLET / ORALAB1993-10-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074342-001ALPRAZOLAM0.25MGTABLET / ORALAB1993-10-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A074342-002ALPRAZOLAM0.5MGTABLET / ORALAB1993-10-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A074342-003ALPRAZOLAM1MGTABLET / ORALAB1993-10-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A074342-004ALPRAZOLAM2MGTABLET / ORALAB1993-10-31d06236e962d9…

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 UTC2026-02A074342-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074342-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074342-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074342-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074342-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074342-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074342-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074342-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074342-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074342-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074342-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074342-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074342-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074342-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074342-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074342-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074342-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074342-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074342-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074342-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074342-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074342-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074342-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074342-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074342-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074342-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074342-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074342-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074342-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074342-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074342-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074342-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074342-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074342-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074342-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074342-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074342-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074342-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074342-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074342-004AB1d06236e962d9…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5109-0Alprazolam30 in 1 BOTTLETABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5109ALPRAZOLAM TABLET [A-S MEDICATION SOLUTIONS]3Legacy NDC, 1 package rows20210615_b53734c7-e0e9-40e7-80a7-e9c0e52d27a5.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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AlprazolamALPRAZOLAMA-S Medication Solutions8ef75d22-4a7c-48d5-a532-5a43b8593e7c2026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074342
application number: ANDA074342
AlprazolamALPRAZOLAMPD-Rx Pharmaceuticals, Inc.5040e1ed-32d6-4757-a0ee-b8240f3e7cf52025-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074342
application number: ANDA074342
AlprazolamALPRAZOLAMPD-Rx Pharmaceuticals, Inc.2f16ff78-1262-4bb8-9a25-822c13c4746f2025-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074342
application number: ANDA074342
AlprazolamALPRAZOLAMAdvanced Rx of Tennessee, LLCb39e2bc8-b68f-0f4e-e053-2995a90a00fd2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074342
application number: ANDA074342
AlprazolamALPRAZOLAMAdvanced Rx of Tennessee, LLCb4cd647f-1ba3-334e-e053-2995a90af3522024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074342
application number: ANDA074342
AlprazolamALPRAZOLAMQuality Care Products, LLC8be0bc5e-3566-4fbd-a27d-634e64fd6d782024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074342
application number: ANDA074342
AlprazolamALPRAZOLAMNuCare Pharmaceuticals,Inc.aaf7979c-168a-0da2-e053-2995a90a4d122024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074342
application number: ANDA074342
AlprazolamALPRAZOLAMNuCare Pharmaceuticals,Inc.b43df4ca-8d28-7b3a-e053-2a95a90aa4d72024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074342
application number: ANDA074342
AlprazolamALPRAZOLAMBryant Ranch Prepack8ca8e0fc-6c3d-48d4-ad04-708182b453502024-05-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074342
application number: ANDA074342
AlprazolamALPRAZOLAMBryant Ranch Prepack25781f50-d309-4c4f-9e21-c019e068d1012024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074342
application number: ANDA074342
AlprazolamALPRAZOLAMActavis Pharma, Inc.a23063c0-099a-4256-b95f-3a857bbf704b2023-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074342
application number: ANDA074342
AlprazolamALPRAZOLAMAphena Pharma Solutions - Tennessee, LLC29ddd9f2-c116-467b-8db3-38166482aea02018-08-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074342
application number: ANDA074342
AlprazolamALPRAZOLAMAphena Pharma Solutions - Tennessee, LLC2717699a-c8b6-4590-937a-cb86eadc52962018-08-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074342
application number: ANDA074342

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308047ALPRAZolam 0.25 MG Oral TabletPSNb53734c7-e0e9-40e7-80a7-e9c0e52d27a53
308047alprazolam 0.25 MG Oral TabletSCDb53734c7-e0e9-40e7-80a7-e9c0e52d27a53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5109-05009051090030 TABLET in 1 BOTTLE (50090-5109-0) 30 tablet2020-07-210000-00-00NoNoCurrent