Alprazolam

Product NDC
50090-1759
Requested package NDC
50090-1759-3
11-digit product format
500901759
Labeler code
50090
Product ID
50090-1759_d5e0249a-0d5c-4703-8f8f-b082328da573
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA074174
Marketing category
ANDA
Marketing start
2007-03-28
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
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-175950090-1759-3IInactivated by FDA2026-08-03

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 · 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
A074174-001ALPRAZOLAMALPRAZOLAM0.25MGTABLET / ORALAB1993-10-19
A074174-002ALPRAZOLAMALPRAZOLAM0.5MGTABLET / ORALAB1993-10-19
A074174-003ALPRAZOLAMALPRAZOLAM1MGTABLET / ORALAB1993-10-19
A074174-004ALPRAZOLAMALPRAZOLAM2MGTABLET / ORALAB1993-10-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074174-001AB
A074174-002AB
A074174-003AB
A074174-004AB

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 UTC2026-02A074174-001ALPRAZOLAM0.25MGTABLET / ORALAB1993-10-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074174-002ALPRAZOLAM0.5MGTABLET / ORALAB1993-10-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074174-003ALPRAZOLAM1MGTABLET / ORALAB1993-10-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074174-004ALPRAZOLAM2MGTABLET / ORALAB1993-10-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074174-001ALPRAZOLAM0.25MGTABLET / ORALAB1993-10-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074174-002ALPRAZOLAM0.5MGTABLET / ORALAB1993-10-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074174-003ALPRAZOLAM1MGTABLET / ORALAB1993-10-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074174-004ALPRAZOLAM2MGTABLET / ORALAB1993-10-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A074174-001ALPRAZOLAM0.25MGTABLET / ORALAB1993-10-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074174-002ALPRAZOLAM0.5MGTABLET / ORALAB1993-10-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074174-003ALPRAZOLAM1MGTABLET / ORALAB1993-10-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074174-004ALPRAZOLAM2MGTABLET / ORALAB1993-10-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074174-001ALPRAZOLAM0.25MGTABLET / ORALAB1993-10-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074174-002ALPRAZOLAM0.5MGTABLET / ORALAB1993-10-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074174-003ALPRAZOLAM1MGTABLET / ORALAB1993-10-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074174-004ALPRAZOLAM2MGTABLET / ORALAB1993-10-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074174-001ALPRAZOLAM0.25MGTABLET / ORALAB1993-10-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074174-002ALPRAZOLAM0.5MGTABLET / ORALAB1993-10-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074174-003ALPRAZOLAM1MGTABLET / ORALAB1993-10-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074174-004ALPRAZOLAM2MGTABLET / ORALAB1993-10-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074174-001ALPRAZOLAM0.25MGTABLET / ORALAB1993-10-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074174-002ALPRAZOLAM0.5MGTABLET / ORALAB1993-10-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074174-003ALPRAZOLAM1MGTABLET / ORALAB1993-10-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074174-004ALPRAZOLAM2MGTABLET / ORALAB1993-10-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074174-001ALPRAZOLAM0.25MGTABLET / ORALAB1993-10-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074174-002ALPRAZOLAM0.5MGTABLET / ORALAB1993-10-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074174-003ALPRAZOLAM1MGTABLET / ORALAB1993-10-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074174-004ALPRAZOLAM2MGTABLET / ORALAB1993-10-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074174-001ALPRAZOLAM0.25MGTABLET / ORALAB1993-10-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074174-002ALPRAZOLAM0.5MGTABLET / ORALAB1993-10-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074174-003ALPRAZOLAM1MGTABLET / ORALAB1993-10-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074174-004ALPRAZOLAM2MGTABLET / ORALAB1993-10-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074174-001ALPRAZOLAM0.25MGTABLET / ORALAB1993-10-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074174-002ALPRAZOLAM0.5MGTABLET / ORALAB1993-10-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074174-003ALPRAZOLAM1MGTABLET / ORALAB1993-10-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074174-004ALPRAZOLAM2MGTABLET / ORALAB1993-10-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074174-001ALPRAZOLAM0.25MGTABLET / ORALAB1993-10-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A074174-002ALPRAZOLAM0.5MGTABLET / ORALAB1993-10-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A074174-003ALPRAZOLAM1MGTABLET / ORALAB1993-10-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A074174-004ALPRAZOLAM2MGTABLET / ORALAB1993-10-19d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 148 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A074174-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074174-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074174-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074174-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074174-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074174-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074174-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074174-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074174-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074174-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074174-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074174-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074174-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074174-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074174-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074174-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074174-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074174-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074174-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074174-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074174-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074174-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074174-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074174-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074174-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074174-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074174-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074174-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074174-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074174-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074174-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074174-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074174-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074174-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074174-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074174-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074174-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074174-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074174-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074174-004AB1d06236e962d9…

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
50090-1759-0Alprazolam30 in 1 BOTTLETABLET3021
50090-1759-1Alprazolam20 in 1 BOTTLETABLET2021
50090-1759-2Alprazolam60 in 1 BOTTLETABLET6021
50090-1759-3Alprazolam90 in 1 BOTTLETABLET9021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1759-0EA - Each50090-1759c7efe3ac-8e49-40cc-b8a3-06396ba022f512018-10-11
50090-1759-1EA - Each50090-17593b3386fe-73c3-4a40-a9ba-8a494cc383c112018-09-05
50090-1759-2EA - Each50090-1759d9c1e57f-68e2-4cd2-a3b6-9e555625626912018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1759ALPRAZOLAM TABLET [A-S MEDICATION SOLUTIONS]21Legacy NDC, 4 package rows20210226_cb179805-0e57-4902-82ed-bcfeb6b64528.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AlprazolamALPRAZOLAMANI Pharmaceuticals, Inc.38428a1b-718c-49cc-94ae-2e3644ba62562023-06-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074174
application number: ANDA074174

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308048ALPRAZolam 0.5 MG Oral TabletPSNcb179805-0e57-4902-82ed-bcfeb6b6452821
308048alprazolam 0.5 MG Oral TabletSCDcb179805-0e57-4902-82ed-bcfeb6b6452821

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1759-35009017590390 TABLET in 1 BOTTLE (50090-1759-3) 90 tablet2015-03-260000-00-00NoNoCurrent