FDA.reportPublic FDA data

ZALEPLON

Product NDC
61919-629
11-digit product format
619190629
Labeler code
61919
Product ID
61919-629_1d0d2582-07d9-4078-854a-891133eecf74
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ZALEPLON
Dosage form
CAPSULE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA078989
Marketing category
ANDA
Marketing start
2015-01-01
Marketing end
0000-00-00
Substance
ZALEPLON
Active strength
10 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
61919-629-302020-01-31C16284748780-19d75b9d0-20e0-f424-e053-dadaa90a57ceZALEPLON
61919-629-602020-01-31C16284748780-19d75b9d0-20e0-f424-e053-dadaa90a57ceZALEPLON

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-629-30ZALEPLON30 in 1 BOTTLECAPSULE302
61919-629-60ZALEPLON60 in 1 BOTTLECAPSULE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-629-30EA - Each61919-6295d6cc42d-d216-4654-b87d-2f6cbb2e778612015-10-02
61919-629-60EA - Each61919-6297644dbf6-37a6-474c-9d6c-a5c4e95aa94b12014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZALEPLONACTIVE INGREDIENTS62U433RMHZALEPLON CAPSULE [DIRECT RX]2
ZALEPLONACTIVE MOIETYS62U433RMHZALEPLON CAPSULE [DIRECT RX]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZALEPLON CAPSULE [DIRECT RX]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ZALEPLON CAPSULE [DIRECT RX]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDZALEPLON CAPSULE [DIRECT RX]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAZALEPLON CAPSULE [DIRECT RX]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ZALEPLON CAPSULE [DIRECT RX]2
GELATININACTIVE INGREDIENT2G86QN327LZALEPLON CAPSULE [DIRECT RX]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XZALEPLON CAPSULE [DIRECT RX]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZALEPLON CAPSULE [DIRECT RX]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JZALEPLON CAPSULE [DIRECT RX]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJZALEPLON CAPSULE [DIRECT RX]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZALEPLON CAPSULE [DIRECT RX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-629ZALEPLON CAPSULE [DIRECT RX]2Legacy NDC, 2 package rows20150813_d4871d67-cdf5-4801-9349-9ec4146df49f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313761zaleplon 10 MG Oral CapsulePSNd4871d67-cdf5-4801-9349-9ec4146df49f2
313761zaleplon 10 MG Oral CapsuleSCDd4871d67-cdf5-4801-9349-9ec4146df49f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-629-306191906293030 in 1 BOTTLEHistorical
61919-629-606191906296060 in 1 BOTTLEHistorical