FDA.reportPublic FDA data

Zaleplon

Product NDC
0093-5268
11-digit product format
000935268
Labeler code
0093
Product ID
0093-5268_34b1199c-f8d1-4ba1-b0c2-7954b5248a4c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zaleplon
Dosage form
CAPSULE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA077239
Marketing category
ANDA
Marketing start
2008-06-06
Marketing end
2020-04-30
Substance
ZALEPLON
Active strength
5 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
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-5268-01EA - Each0093-526895f44d54-523b-4d0a-b652-9de442449f2912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZALEPLONACTIVE INGREDIENTS62U433RMHZALEPLON CAPSULE [DISPENSING SOLUTIONS, INC.]2
ZALEPLONACTIVE MOIETYS62U433RMHZALEPLON CAPSULE [DISPENSING SOLUTIONS, INC.]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933ZALEPLON CAPSULE [DISPENSING SOLUTIONS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZALEPLON CAPSULE [DISPENSING SOLUTIONS, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GZALEPLON CAPSULE [DISPENSING SOLUTIONS, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDZALEPLON CAPSULE [DISPENSING SOLUTIONS, INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKZALEPLON CAPSULE [DISPENSING SOLUTIONS, INC.]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SZALEPLON CAPSULE [DISPENSING SOLUTIONS, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAZALEPLON CAPSULE [DISPENSING SOLUTIONS, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ZALEPLON CAPSULE [DISPENSING SOLUTIONS, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LZALEPLON CAPSULE [DISPENSING SOLUTIONS, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XZALEPLON CAPSULE [DISPENSING SOLUTIONS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZALEPLON CAPSULE [DISPENSING SOLUTIONS, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ZALEPLON CAPSULE [DISPENSING SOLUTIONS, INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OZALEPLON CAPSULE [DISPENSING SOLUTIONS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ZALEPLON CAPSULE [DISPENSING SOLUTIONS, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JZALEPLON CAPSULE [DISPENSING SOLUTIONS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJZALEPLON CAPSULE [DISPENSING SOLUTIONS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZALEPLON CAPSULE [DISPENSING SOLUTIONS, INC.]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313762zaleplon 5 MG Oral CapsulePSNec68d050-be3f-4150-9f86-22c957dddb912
313762zaleplon 5 MG Oral CapsuleSCDec68d050-be3f-4150-9f86-22c957dddb912