Alprazolam

Product NDC
50090-2819
11-digit product format
500902819
Labeler code
50090
Product ID
50090-2819_71cb1809-575a-436e-be2f-2a457cd1a17d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA074909
Marketing category
ANDA
Marketing start
1998-03-25
Marketing end
2027-03-19
Substance
ALPRAZOLAM
Active strength
2 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
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 packagepackage50090-281950090-2819-1DDiscontinued by firm2026-08-03

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-281950090-2819-1DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-281950090-2819-1DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074909-001ALPRAZOLAMALPRAZOLAM2MGTABLET / ORALAB1998-03-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074909-001AB

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074909-001ALPRAZOLAM2MGTABLET / ORALAB1998-03-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074909-001ALPRAZOLAM2MGTABLET / ORALAB1998-03-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A074909-001ALPRAZOLAM2MGTABLET / ORALAB1998-03-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074909-001ALPRAZOLAM2MGTABLET / ORALAB1998-03-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074909-001ALPRAZOLAM2MGTABLET / ORALAB1998-03-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074909-001ALPRAZOLAM2MGTABLET / ORALAB1998-03-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074909-001ALPRAZOLAM2MGTABLET / ORALAB1998-03-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074909-001ALPRAZOLAM2MGTABLET / ORALAB1998-03-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074909-001ALPRAZOLAM2MGTABLET / ORALAB1998-03-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074909-001ALPRAZOLAM2MGTABLET / ORALAB1998-03-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074909-001ALPRAZOLAM2MGTABLET / ORALAB1998-03-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074909-001ALPRAZOLAM2MGTABLET / ORALAB1998-03-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074909-001ALPRAZOLAM2MGTABLET / ORALAB1998-03-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074909-001ALPRAZOLAM2MGTABLET / ORALAB1998-03-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074909-001ALPRAZOLAM2MGTABLET / ORALAB1998-03-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074909-001ALPRAZOLAM2MGTABLET / ORALAB1998-03-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074909-001ALPRAZOLAM2MGTABLET / ORALAB1998-03-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074909-001ALPRAZOLAM2MGTABLET / ORALAB1998-03-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074909-001ALPRAZOLAM2MGTABLET / ORALAB1998-03-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074909-001ALPRAZOLAM2MGTABLET / ORALAB1998-03-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074909-001ALPRAZOLAM2MGTABLET / ORALAB1998-03-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A074909-001ALPRAZOLAM2MGTABLET / ORALAB1998-03-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074909-001ALPRAZOLAM2MGTABLET / ORALAB1998-03-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074909-001ALPRAZOLAM2MGTABLET / ORALAB1998-03-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074909-001ALPRAZOLAM2MGTABLET / ORALAB1998-03-253f01610625f2…
2019-09-15 20:21 UTC2019-09A074909-001ALPRAZOLAM2MGTABLET / ORALAB1998-03-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A074909-001ALPRAZOLAM2MGTABLET / ORALAB1998-03-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074909-001ALPRAZOLAM2MGTABLET / ORALAB1998-03-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074909-001ALPRAZOLAM2MGTABLET / ORALAB1998-03-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074909-001ALPRAZOLAM2MGTABLET / ORALAB1998-03-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074909-001ALPRAZOLAM2MGTABLET / ORALAB1998-03-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074909-001ALPRAZOLAM2MGTABLET / ORALAB1998-03-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074909-001ALPRAZOLAM2MGTABLET / ORALAB1998-03-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074909-001ALPRAZOLAM2MGTABLET / ORALAB1998-03-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A074909-001ALPRAZOLAM2MGTABLET / ORALAB1998-03-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A074909-001ALPRAZOLAM2MGTABLET / ORALAB1998-03-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074909-001ALPRAZOLAM2MGTABLET / ORALAB1998-03-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074909-001ALPRAZOLAM2MGTABLET / ORALAB1998-03-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074909-001ALPRAZOLAM2MGTABLET / ORALAB1998-03-25e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074909-001ALPRAZOLAM2MGTABLET / ORALAB1998-03-25cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A074909-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074909-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074909-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074909-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074909-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074909-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074909-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074909-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074909-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074909-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074909-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074909-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074909-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074909-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074909-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074909-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074909-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074909-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074909-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074909-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074909-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A074909-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074909-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074909-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074909-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A074909-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074909-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074909-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074909-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074909-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074909-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074909-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074909-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074909-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A074909-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A074909-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074909-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074909-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074909-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074909-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Alprazolam

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALPRAZOLAM2 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197321Internal RxNorm lookup
197322Internal RxNorm lookup
308047Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3c0cb60f-1c3a-48a6-ad16-f14351548412Available 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
50090-2819-1Alprazolam90 in 1 BOTTLETABLET9027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2819-1EA - Each50090-2819ea651aee-8441-4cd3-b5f5-206be5b374c612018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2819ALPRAZOLAM TABLET [A-S MEDICATION SOLUTIONS]24Current NDC, Legacy NDC, 1 package rows20250516_3c0cb60f-1c3a-48a6-ad16-f14351548412.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AlprazolamALPRAZOLAMA-S Medication Solutions3c0cb60f-1c3a-48a6-ad16-f143515484122025-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074909
application number: ANDA074909
ndc (product): 50090-2819
AlprazolamALPRAZOLAMPD-Rx Pharmaceuticals, Inc.7538d0d0-346e-4c3e-8f7a-c1cac8ec8ed32025-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074909
application number: ANDA074909
AlprazolamALPRAZOLAMSandoz Incd9b0e228-17cf-40d7-b62e-5050311c571c2024-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074909
application number: ANDA074909
AlprazolamALPRAZOLAMBryant Ranch Prepackb0000772-2514-45a2-a75d-1bbb13c299892024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074909
application number: ANDA074909
AlprazolamALPRAZOLAMProficient Rx LP717ce509-f92e-4ec1-a3c6-aeae54d56f4d2020-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074909
application number: ANDA074909

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308047ALPRAZolam 0.25 MG Oral TabletPSN3c0cb60f-1c3a-48a6-ad16-f1435154841227
197321ALPRAZolam 1 MG Oral TabletPSN3c0cb60f-1c3a-48a6-ad16-f1435154841227
197322ALPRAZolam 2 MG Oral TabletPSN3c0cb60f-1c3a-48a6-ad16-f1435154841227
308047alprazolam 0.25 MG Oral TabletSCD3c0cb60f-1c3a-48a6-ad16-f1435154841227
197321alprazolam 1 MG Oral TabletSCD3c0cb60f-1c3a-48a6-ad16-f1435154841227
197322alprazolam 2 MG Oral TabletSCD3c0cb60f-1c3a-48a6-ad16-f1435154841227

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-2819-15009028190190 in 1 BOTTLEHistorical