FDA.reportPublic FDA data

ALPRAZOLAM

Product NDC
61919-836
11-digit product format
619190836
Labeler code
61919
Product ID
61919-836_94deef57-a142-365d-e053-2995a90ab691
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ALPRAZOLAM
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA074174
Marketing category
ANDA
Marketing start
2019-07-12
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
2020-12-31
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
61919-836-302023-01-30C16284748780-1f386c649-c56a-0266-e053-dadaa90a7c1aALPRAZOLAM
61919-836-602023-01-30C16284748780-1f386c64a-1e3a-0266-e053-dadaa90a7c1aALPRAZOLAM
61919-836-902023-01-30C16284748780-1f386c64a-1e3a-0266-e053-dadaa90a7c1aALPRAZOLAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-836-60ALPRAZOLAM60 in 1 BOTTLETABLET602
61919-836-90ALPRAZOLAM90 in 1 BOTTLETABLET902
61919-836-30ALPRAZOLAM30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-836-30EA - Each61919-8364d8f5e08-d47c-4679-a52c-48040cb42d1312019-08-06
61919-836-60EA - Each61919-8360e235018-2c3a-45dd-a213-fc76bf186b2512019-05-02
61919-836-90EA - Each61919-83600886c7e-381b-4bf6-bad1-b6c2cf1bb67c12019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-836ALPRAZOLAM TABLET [DIRECT_RX]2Legacy NDC, 2 package rows20191015_8d7db610-3bac-6a1d-e053-2a95a90a3351.zip
61919-836ALPRAZOLAM TABLET [DIRECT_RX]1Legacy NDC, 1 package rows20190713_8d7e0add-0d61-1794-e053-2a95a90af82b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197321ALPRAZolam 1 MG Oral TabletPSN8d7db610-3bac-6a1d-e053-2a95a90a33512
197321alprazolam 1 MG Oral TabletSCD8d7db610-3bac-6a1d-e053-2a95a90a33512
197321ALPRAZolam 1 MG Oral TabletPSN8d7e0add-0d61-1794-e053-2a95a90af82b1
197321alprazolam 1 MG Oral TabletSCD8d7e0add-0d61-1794-e053-2a95a90af82b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-836-306191908363030 TABLET in 1 BOTTLE (61919-836-30) 30 tablet2019-07-120000-00-00NoNoCurrent
61919-836-606191908366060 TABLET in 1 BOTTLE (61919-836-60) 60 tablet2019-07-120000-00-00NoNoCurrent
61919-836-906191908369090 TABLET in 1 BOTTLE (61919-836-90) 90 tablet2019-07-120000-00-00NoNoCurrent