FDA.reportPublic FDA data

Alprazolam

Product NDC
21695-602
11-digit product format
216950602
Labeler code
21695
Product ID
21695-602_1f1c17ab-5bfb-4084-a89e-f0c71a04dfbc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA078387
Marketing category
ANDA
Marketing start
2009-12-03
Marketing end
0000-00-00
Substance
ALPRAZOLAM
Active strength
1 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
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
21695-602-602019-09-24C16284748780-1934fe258-476a-48b1-e053-8cdaa90a720aAlprazolam Extended-Release Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-602-60Alprazolam60 in 1 BOTTLETABLET, EXTENDED RELEASE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-602-60EA - Each21695-60274562da6-5c53-465e-90a7-9a9d52afdb1f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GALPRAZOLAM TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-602ALPRAZOLAM TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 1 package rows20100628_98cc444a-2c39-4410-8020-aded0a8deb81.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
433798ALPRAZolam 0.5 MG 24HR Extended Release Oral TabletPSN98cc444a-2c39-4410-8020-aded0a8deb811
433800ALPRAZolam 1 MG 24HR Extended Release Oral TabletPSN98cc444a-2c39-4410-8020-aded0a8deb811
433799ALPRAZolam 2 MG 24HR Extended Release Oral TabletPSN98cc444a-2c39-4410-8020-aded0a8deb811
43379824 HR alprazolam 0.5 MG Extended Release Oral TabletSCD98cc444a-2c39-4410-8020-aded0a8deb811
43380024 HR alprazolam 1 MG Extended Release Oral TabletSCD98cc444a-2c39-4410-8020-aded0a8deb811
43379924 HR alprazolam 2 MG Extended Release Oral TabletSCD98cc444a-2c39-4410-8020-aded0a8deb811
433798alprazolam 0.5 MG 24 HR Extended Release Oral TabletSY98cc444a-2c39-4410-8020-aded0a8deb811
433800alprazolam 1 MG 24 HR Extended Release Oral TabletSY98cc444a-2c39-4410-8020-aded0a8deb811
433799alprazolam 2 MG 24 HR Extended Release Oral TabletSY98cc444a-2c39-4410-8020-aded0a8deb811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-602-602169506026060 in 1 BOTTLEHistorical