Alprazolam

Product NDC
53002-4180
11-digit product format
530024180
Labeler code
53002
Product ID
53002-4180_1304762d-8d74-4c7c-b63d-176ede8187af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA074174
Marketing category
ANDA
Marketing start
2007-03-28
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
2021-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-4180-1Alprazolam10 in 1 BOTTLETABLET103
53002-4180-2Alprazolam20 in 1 BOTTLETABLET203
53002-4180-3Alprazolam30 in 1 BOTTLETABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-4180ALPRAZOLAM TABLET [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 3 package rows20201218_a1072746-7662-4b15-b1d5-9e5f9421282c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308047ALPRAZolam 0.25 MG Oral TabletPSNa1072746-7662-4b15-b1d5-9e5f9421282c3
308047alprazolam 0.25 MG Oral TabletSCDa1072746-7662-4b15-b1d5-9e5f9421282c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-4180-15300241800110 TABLET in 1 BOTTLE (53002-4180-1) 10 tablet2017-10-010000-00-00NoNoCurrent
53002-4180-25300241800220 TABLET in 1 BOTTLE (53002-4180-2) 20 tablet2017-10-010000-00-00NoNoCurrent
53002-4180-35300241800330 TABLET in 1 BOTTLE (53002-4180-3) 30 tablet2017-10-010000-00-00NoNoCurrent