FDA.reportPublic FDA data

Zaleplon

Product NDC
71335-1387
11-digit product format
713351387
Labeler code
71335
Product ID
71335-1387_7565a029-6542-45fe-b823-e522d0583fd7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zaleplon
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090374
Marketing category
ANDA
Marketing start
2018-06-20
Marketing end
0000-00-00
Substance
ZALEPLON
Active strength
10 mg/1
Pharmacologic classes
Central Nervous System Depression [PE], GABA A Agonists [MoA], gamma-Aminobutyric Acid A Receptor Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
11ca9bc5-afb0-a2d5-938a-c2d33f89f4abProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1387-12024-01-30C16284748780-11030e364-ff47-111a-e063-dadaa90a10e2Zaleplon Capsules , USP CIV
71335-1387-22024-01-30C16284748780-11030e364-ff47-111a-e063-dadaa90a10e2Zaleplon Capsules , USP CIV
71335-1387-32024-01-30C16284748780-11030e364-ff47-111a-e063-dadaa90a10e2Zaleplon Capsules , USP CIV
71335-1387-42024-01-30C16284748780-11030e364-ff47-111a-e063-dadaa90a10e2Zaleplon Capsules , USP CIV

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1387-1Zaleplon15 in 1 BOTTLECAPSULE155
71335-1387-2Zaleplon30 in 1 BOTTLECAPSULE305
71335-1387-3Zaleplon60 in 1 BOTTLECAPSULE605
71335-1387-4Zaleplon90 in 1 BOTTLECAPSULE905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1387ZALEPLON CAPSULE [BRYANT RANCH PREPACK]5Legacy NDC, 4 package rows20220226_7565a029-6542-45fe-b823-e522d0583fd7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313761zaleplon 10 MG Oral CapsulePSN7565a029-6542-45fe-b823-e522d0583fd75
313761zaleplon 10 MG Oral CapsuleSCD7565a029-6542-45fe-b823-e522d0583fd75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1387-17133513870115 CAPSULE in 1 BOTTLE (71335-1387-1) 15 capsule2019-11-110000-00-00NoNoCurrent
71335-1387-27133513870230 CAPSULE in 1 BOTTLE (71335-1387-2) 30 capsule2019-11-110000-00-00NoNoCurrent
71335-1387-37133513870360 CAPSULE in 1 BOTTLE (71335-1387-3) 60 capsule2019-11-110000-00-00NoNoCurrent
71335-1387-47133513870490 CAPSULE in 1 BOTTLE (71335-1387-4) 90 capsule2019-11-110000-00-00NoNoCurrent