FDA.reportPublic FDA data

ALPRAZOLAM

Product NDC
61919-379
11-digit product format
619190379
Labeler code
61919
Product ID
61919-379_92d922a0-5a29-9cf9-e053-2995a90a0cbd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ALPRAZOLAM
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA078491
Marketing category
ANDA
Marketing start
2017-11-01
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
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61919-379IInactivated by FDA2026-08-03
excluded packagepackage61919-37961919-379-30IInactivated by FDA2026-08-03

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
A078491-001ALPRAZOLAMALPRAZOLAM0.25MGTABLET / ORAL2008-09-25
A078491-002ALPRAZOLAMALPRAZOLAM0.5MGTABLET / ORAL2008-09-25
A078491-003ALPRAZOLAMALPRAZOLAM1MGTABLET / ORAL2008-09-25
A078491-004ALPRAZOLAMALPRAZOLAM2MGTABLET / ORAL2008-12-12

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A078491-001ALPRAZOLAM0.25MGTABLET / ORAL2008-09-25a50c72e98297…
2026-08-01 22:54:322026-06A078491-002ALPRAZOLAM0.5MGTABLET / ORAL2008-09-25a50c72e98297…
2026-08-01 22:54:322026-06A078491-003ALPRAZOLAM1MGTABLET / ORAL2008-09-25a50c72e98297…
2026-08-01 22:54:322026-06A078491-004ALPRAZOLAM2MGTABLET / ORAL2008-12-12a50c72e98297…

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
61919-379-302023-01-30C16284748780-1f386c649-e5ef-0266-e053-dadaa90a7c1a​ALPRAZOLAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-379-30ALPRAZOLAM30 in 1 BOTTLETABLET306

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [DIRECT RX]1
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [DIRECT RX]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [DIRECT RX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [DIRECT RX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALPRAZOLAM TABLET [DIRECT RX]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ALPRAZOLAM TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-379ALPRAZOLAM TABLET [DIRECT_RX]6Legacy NDC, 1 package rows20190919_bc9dff5c-db3b-4cdf-b0bc-7ef94fd38486.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308047ALPRAZolam 0.25 MG Oral TabletPSNbc9dff5c-db3b-4cdf-b0bc-7ef94fd384866
308047alprazolam 0.25 MG Oral TabletSCDbc9dff5c-db3b-4cdf-b0bc-7ef94fd384866

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-379-306191903793030 TABLET in 1 BOTTLE (61919-379-30) 30 tablet2019-09-180000-00-00NoNoCurrent