Spinosad

Product NDC
28595-570
11-digit product format
285950570
Labeler code
28595
Product ID
28595-570_462b23e2-dcbb-b932-e063-6294a90a2cdd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
spinosad
Dosage form
SUSPENSION
Route
TOPICAL
Labeler
Allegis Pharmaceuticals, LLC
Application
NDA022408
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-06-25
Marketing end
2027-06-30
Substance
SPINOSAD
Active strength
9 mg/mL
Pharmacologic classes
Pediculicide [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Spinosad

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SPINOSAD9 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiXPA88EAP6V
Rxcui1085816

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
51bc04ae-91cb-4b68-a5f5-55e3393918a4Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
28595-570-04Spinosad1 in 1 CARTONSUSPENSION19
28595-570-04Spinosad120 mL in 1 BOTTLE, PLASTICSUSPENSION1209

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
28595-570-04ML - Milliliter28595-5705a66b273-4598-4d68-a4bd-964328e1220212014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
spinosadACTIVE INGREDIENTXPA88EAP6VSPINOSAD SUSPENSION [ALLEGIS PHARMACEUTICALS, LLC]2
spinosadACTIVE MOIETYXPA88EAP6VSPINOSAD SUSPENSION [ALLEGIS PHARMACEUTICALS, LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RSPINOSAD SUSPENSION [ALLEGIS PHARMACEUTICALS, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
28595-570SPINOSAD SUSPENSION [ALLEGIS PHARMACEUTICALS, LLC]8Current NDC, Legacy NDC, 2 package rows20250110_8e87bd3b-db25-4e97-bf57-96c875f67ce1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1085816spinosad 0.9 % Topical SuspensionPSN8e87bd3b-db25-4e97-bf57-96c875f67ce19
1085816spinosad 9 MG/ML Medicated ShampooSCD8e87bd3b-db25-4e97-bf57-96c875f67ce19
1085816spinosad 0.9 % Medicated ShampooSY8e87bd3b-db25-4e97-bf57-96c875f67ce19
1085816spinosad 0.9 % Topical SuspensionSY8e87bd3b-db25-4e97-bf57-96c875f67ce19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
28595-570-04285950570041 BOTTLE, PLASTIC in 1 CARTON (28595-570-04) / 120 mL in 1 BOTTLE, PLASTIC2014-06-252027-06-30NoNoCurrent