FDA.reportPublic FDA data

Alprazolam

Product NDC
21695-250
11-digit product format
216950250
Labeler code
21695
Product ID
21695-250_4f300492-4080-499d-b872-a8bf9de3cc7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA074909
Marketing category
ANDA
Marketing start
1998-03-25
Marketing end
0000-00-00
Substance
ALPRAZOLAM
Active strength
2 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
21695-250-302019-09-24C16284748780-1934fe258-47eb-48b1-e053-8cdaa90a720aAlprazolam Tablets, USP
21695-250-602019-09-24C16284748780-1934fe258-47eb-48b1-e053-8cdaa90a720aAlprazolam Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-250-30Alprazolam30 in 1 BOTTLETABLET301
21695-250-60Alprazolam60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-250-30EA - Each21695-250fe6f67cc-af77-4729-a121-353254b27fd812012-07-24
21695-250-60EA - Each21695-25086c08029-882c-409f-b4fd-a84e9b8ce00a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AlprazolamACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]1
AlprazolamACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]1
docusate sodiumINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]1
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]1
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]1
starch, cornINACTIVE INGREDIENTO8232NY3SJALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-250ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 2 package rows20100331_d7a54ceb-2d80-4879-950f-cad362324086.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308047ALPRAZolam 0.25 MG Oral TabletPSNd7a54ceb-2d80-4879-950f-cad3623240861
308048ALPRAZolam 0.5 MG Oral TabletPSNd7a54ceb-2d80-4879-950f-cad3623240861
197321ALPRAZolam 1 MG Oral TabletPSNd7a54ceb-2d80-4879-950f-cad3623240861
197322ALPRAZolam 2 MG Oral TabletPSNd7a54ceb-2d80-4879-950f-cad3623240861
308047alprazolam 0.25 MG Oral TabletSCDd7a54ceb-2d80-4879-950f-cad3623240861
308048alprazolam 0.5 MG Oral TabletSCDd7a54ceb-2d80-4879-950f-cad3623240861
197321alprazolam 1 MG Oral TabletSCDd7a54ceb-2d80-4879-950f-cad3623240861
197322alprazolam 2 MG Oral TabletSCDd7a54ceb-2d80-4879-950f-cad3623240861

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-250-302169502503030 in 1 BOTTLEHistorical
21695-250-602169502506060 in 1 BOTTLEHistorical