zaleplon

Product NDC
42254-189
11-digit product format
422540189
Labeler code
42254
Product ID
42254-189_f493f828-9fdd-4723-9fc7-f691d3879696
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zaleplon
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA078989
Marketing category
ANDA
Marketing start
2009-05-05
Marketing end
0000-00-00
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
E
Listing certified through
2017-12-31
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
42254-189-602019-09-24C16284748780-19350213a-3d8b-c013-e053-90daa90a1393Zaleplon Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-189-60zaleplon60 in 1 BOTTLE, PLASTICCAPSULE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-189-60EA - Each42254-18981a6da49-7ef6-4ee0-83cf-24c3185355f712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZALEPLONACTIVE INGREDIENTS62U433RMHZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP]1
ZALEPLONACTIVE MOIETYS62U433RMHZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP]1
GELATININACTIVE INGREDIENT2G86QN327LZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-189ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20120511_f493f828-9fdd-4723-9fc7-f691d3879696.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313762zaleplon 5 MG Oral CapsulePSNf493f828-9fdd-4723-9fc7-f691d38796961
313762zaleplon 5 MG Oral CapsuleSCDf493f828-9fdd-4723-9fc7-f691d38796961

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-189-604225401896060 in 1 BOTTLE, PLASTICHistorical