FDA.reportPublic FDA data

Zaleplon

Product NDC
68788-8725
11-digit product format
687888725
Labeler code
68788
Product ID
68788-8725_c90005da-3a75-4408-b34d-22f2394bf01f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zaleplon
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA090374
Marketing category
ANDA
Marketing start
2024-08-16
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
68788-8725-1Zaleplon100 in 1 BOTTLECAPSULE1002
68788-8725-2Zaleplon20 in 1 BOTTLECAPSULE202
68788-8725-3Zaleplon30 in 1 BOTTLECAPSULE302
68788-8725-6Zaleplon60 in 1 BOTTLECAPSULE602
68788-8725-9Zaleplon90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8725-1EA - Each68788-872585fab208-ca8c-46df-bc77-d40d27d643c512024-10-04
68788-8725-2EA - Each68788-8725d083a4cb-3a92-4f8b-8d35-3ab8abc6d31a12024-10-04
68788-8725-3EA - Each68788-8725d6684daf-5d6c-4512-a7f7-b058878189ae12024-10-04
68788-8725-6EA - Each68788-8725ba518909-9d47-4027-92b4-b56e074edd9d12024-10-04
68788-8725-9EA - Each68788-87257c6be6cd-1993-4de6-95d6-babdc862d15f12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8725ZALEPLON CAPSULE [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 5 package rows20240817_d58138d1-3378-482c-a401-958dabe1be7d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313761zaleplon 10 MG Oral CapsulePSNd58138d1-3378-482c-a401-958dabe1be7d2
313761zaleplon 10 MG Oral CapsuleSCDd58138d1-3378-482c-a401-958dabe1be7d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8725-168788872501100 CAPSULE in 1 BOTTLE (68788-8725-1) 100 capsule2024-08-16NoNoCurrent
68788-8725-26878887250220 CAPSULE in 1 BOTTLE (68788-8725-2) 20 capsule2024-08-16NoNoCurrent
68788-8725-36878887250330 CAPSULE in 1 BOTTLE (68788-8725-3) 30 capsule2024-08-16NoNoCurrent
68788-8725-66878887250660 CAPSULE in 1 BOTTLE (68788-8725-6) 60 capsule2024-08-16NoNoCurrent
68788-8725-96878887250990 CAPSULE in 1 BOTTLE (68788-8725-9) 90 capsule2024-08-16NoNoCurrent