zaleplon

Product NDC
45865-541
11-digit product format
458650541
Labeler code
45865
Product ID
45865-541_9ab2d412-2c8d-5772-e053-2a95a90a83c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zaleplon
Dosage form
CAPSULE
Route
ORAL
Labeler
medsource pharmaceuticals
Application
ANDA078989
Marketing category
ANDA
Marketing start
2009-05-05
Marketing end
0000-00-00
Substance
ZALEPLON
Active strength
10 mg/1
Pharmacologic classes
gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE]
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
11ca9bc5-afb0-a2d5-938a-c2d33f89f4abProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45865-541-302025-01-30C16284748780-12cef2736-8bc8-d83d-e063-dadaa90ab31fZaleplon Capsules USP
45865-541-602025-01-30C16284748780-12cef2736-8bc8-d83d-e063-dadaa90ab31fZaleplon Capsules USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-541-30zaleplon30 in 1 BOTTLE, PLASTICCAPSULE302
45865-541-60zaleplon60 in 1 BOTTLE, PLASTICCAPSULE602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-541ZALEPLON CAPSULE [MEDSOURCE PHARMACEUTICALS]2Legacy NDC, 2 package rows20191228_7d638bba-3180-4fb5-e053-2991aa0a3f34.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313761zaleplon 10 MG Oral CapsulePSN7d638bba-3180-4fb5-e053-2991aa0a3f342
313761zaleplon 10 MG Oral CapsuleSCD7d638bba-3180-4fb5-e053-2991aa0a3f342

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-541-304586505413030 CAPSULE in 1 BOTTLE, PLASTIC (45865-541-30) 30 capsule2018-06-010000-00-00NoNoCurrent
45865-541-604586505416060 CAPSULE in 1 BOTTLE, PLASTIC (45865-541-60) 60 capsule2018-06-010000-00-00NoNoCurrent