FDA.reportPublic FDA data

zaleplon

Product NDC
71335-0236
11-digit product format
713350236
Labeler code
71335
Product ID
71335-0236_2a582cd7-cb01-4ec4-bd0a-d43dcd56c31c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zaleplon
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078989
Marketing category
ANDA
Marketing start
2009-05-05
Substance
ZALEPLON
Active strength
5 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
ZALEPLON5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS62U433RMH
Rxcui313762

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
71335-0236-1zaleplon30 in 1 BOTTLECAPSULE305
71335-0236-2zaleplon60 in 1 BOTTLECAPSULE605
71335-0236-3zaleplon90 in 1 BOTTLECAPSULE905
71335-0236-4zaleplon20 in 1 BOTTLECAPSULE205
71335-0236-5zaleplon28 in 1 BOTTLECAPSULE285

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0236-1EA - Each71335-0236ae630e80-a521-4465-8651-55c30283788412023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0236ZALEPLON CAPSULE [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 5 package rows20231108_d8c88122-ce04-4caf-bd4d-0a4368ea89ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313762zaleplon 5 MG Oral CapsulePSNd8c88122-ce04-4caf-bd4d-0a4368ea89ad5
313762zaleplon 5 MG Oral CapsuleSCDd8c88122-ce04-4caf-bd4d-0a4368ea89ad5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0236-17133502360130 CAPSULE in 1 BOTTLE (71335-0236-1) 30 capsule2019-05-080000-00-00NoNoCurrent
71335-0236-27133502360260 CAPSULE in 1 BOTTLE (71335-0236-2) 60 capsule2018-03-230000-00-00NoNoCurrent
71335-0236-37133502360390 CAPSULE in 1 BOTTLE (71335-0236-3) 90 capsule2021-12-270000-00-00NoNoCurrent
71335-0236-47133502360420 CAPSULE in 1 BOTTLE (71335-0236-4) 20 capsule2021-12-270000-00-00NoNoCurrent
71335-0236-57133502360528 CAPSULE in 1 BOTTLE (71335-0236-5) 28 capsule2021-12-270000-00-00NoNoCurrent