FDA.reportPublic FDA data

zaleplon

Product NDC
68788-7208
11-digit product format
687887208
Labeler code
68788
Product ID
68788-7208_5d4d6d1b-ebe6-4c03-af02-404d12a486b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zaleplon
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA078989
Marketing category
ANDA
Marketing start
2018-08-06
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
zaleplon
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZALEPLON10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS62U433RMH
Rxcui313761

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7208-1zaleplon100 in 1 BOTTLE, PLASTICCAPSULE1008
68788-7208-2zaleplon20 in 1 BOTTLE, PLASTICCAPSULE208
68788-7208-3zaleplon30 in 1 BOTTLE, PLASTICCAPSULE308
68788-7208-6zaleplon60 in 1 BOTTLE, PLASTICCAPSULE608
68788-7208-9zaleplon90 in 1 BOTTLE, PLASTICCAPSULE908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7208ZALEPLON CAPSULE [PREFERRED PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 5 package rows20240906_b0476859-07af-47f1-aec7-61aea0d99d24.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313761zaleplon 10 MG Oral CapsulePSNb0476859-07af-47f1-aec7-61aea0d99d248
313761zaleplon 10 MG Oral CapsuleSCDb0476859-07af-47f1-aec7-61aea0d99d248

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7208-168788720801100 CAPSULE in 1 BOTTLE, PLASTIC (68788-7208-1) 100 capsule2018-08-060000-00-00NoNoCurrent
68788-7208-26878872080220 CAPSULE in 1 BOTTLE, PLASTIC (68788-7208-2) 20 capsule2018-08-060000-00-00NoNoCurrent
68788-7208-36878872080330 CAPSULE in 1 BOTTLE, PLASTIC (68788-7208-3) 30 capsule2018-08-060000-00-00NoNoCurrent
68788-7208-66878872080660 CAPSULE in 1 BOTTLE, PLASTIC (68788-7208-6) 60 capsule2018-08-060000-00-00NoNoCurrent
68788-7208-96878872080990 CAPSULE in 1 BOTTLE, PLASTIC (68788-7208-9) 90 capsule2018-08-060000-00-00NoNoCurrent