zaleplon

Product NDC
33261-486
11-digit product format
332610486
Labeler code
33261
Product ID
33261-486_102c0c6c-be48-40e6-8299-031e8f3dc843
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zaleplon
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
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
No
Listing certified through
2019-12-31
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
33261-486-302020-01-31C16284748780-19d75b9cf-f263-f424-e053-dadaa90a57ceZaleplon Capsules
33261-486-602020-01-31C16284748780-19d75b9cf-f263-f424-e053-dadaa90a57ceZaleplon Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-486-30zaleplon30 in 1 BOTTLE, PLASTICCAPSULE301
33261-486-60zaleplon60 in 1 BOTTLE, PLASTICCAPSULE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-486-30EA - Each33261-486193c05d0-1eab-44d9-aace-239c6141161512015-10-02
33261-486-60EA - Each33261-48641a2bf02-6a60-40ca-a009-27786c60900e12015-10-02

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-486ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 2 package rows20140213_423a4d98-f648-4eed-bd20-857c5a8dde5b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313761zaleplon 10 MG Oral CapsulePSN423a4d98-f648-4eed-bd20-857c5a8dde5b1
313762zaleplon 5 MG Oral CapsulePSN423a4d98-f648-4eed-bd20-857c5a8dde5b1
313761zaleplon 10 MG Oral CapsuleSCD423a4d98-f648-4eed-bd20-857c5a8dde5b1
313762zaleplon 5 MG Oral CapsuleSCD423a4d98-f648-4eed-bd20-857c5a8dde5b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-486-303326104863030 in 1 BOTTLE, PLASTICHistorical
33261-486-603326104866060 in 1 BOTTLE, PLASTICHistorical