Alprazolam

Product NDC
50090-5078
11-digit product format
500905078
Labeler code
50090
Product ID
50090-5078_f8c1781d-12d5-43a2-a215-01ceced386d6
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
Substance
ALPRAZOLAM
Active strength
.5 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-507850090-5078-1DDiscontinued by firm2026-08-03

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Alprazolam
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALPRAZOLAM.5 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308048Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ef75d22-4a7c-48d5-a532-5a43b8593e7cAvailable 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5078-0Alprazolam30 in 1 BOTTLETABLET3012
50090-5078-1Alprazolam20 in 1 BOTTLETABLET2012
50090-5078-2Alprazolam60 in 1 BOTTLETABLET6012
50090-5078-3Alprazolam90 in 1 BOTTLETABLET9012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5078-0EA - Each50090-5078515d41d7-d69b-41e2-a154-0fc62e484d9912023-10-16
50090-5078-1EA - Each50090-5078d2bb0a9f-8b08-45e8-a87b-8a62ec11549612023-10-16
50090-5078-2EA - Each50090-50786eb50e30-0e1e-4fe0-ae6f-905b18b889f312023-10-16
50090-5078-3EA - Each50090-5078d9dab991-7047-41d7-8dd8-975a9973cb2b12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5078ALPRAZOLAM TABLET [A-S MEDICATION SOLUTIONS]10Current NDC, Legacy NDC, 4 package rows20230921_8ef75d22-4a7c-48d5-a532-5a43b8593e7c.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
ndc (product): 50090-5078
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
308048ALPRAZolam 0.5 MG Oral TabletPSN8ef75d22-4a7c-48d5-a532-5a43b8593e7c12
308048alprazolam 0.5 MG Oral TabletSCD8ef75d22-4a7c-48d5-a532-5a43b8593e7c12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5078-05009050780030 TABLET in 1 BOTTLE (50090-5078-0) 30 tablet2020-06-170000-00-00NoNoCurrent
50090-5078-15009050780120 in 1 BOTTLEHistorical
50090-5078-25009050780260 TABLET in 1 BOTTLE (50090-5078-2) 60 tablet2023-09-18NoNoCurrent
50090-5078-35009050780390 TABLET in 1 BOTTLE (50090-5078-3) 90 tablet2020-06-170000-00-00NoNoCurrent