Spinosad

Product NDC
52246-570
11-digit product format
522460570
Labeler code
52246
Product ID
52246-570_f2a068ae-4f02-4647-bb8d-052f82dd8d87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
spinosad
Dosage form
SUSPENSION
Route
TOPICAL
Labeler
ParaPRO LLC
Application
NDA022408
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2024-01-29
Substance
SPINOSAD
Active strength
9 mg/mL
Pharmacologic classes
Pediculicide [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Spinosad
Listing expiration
2026-12-31

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
51bc04ae-91cb-4b68-a5f5-55e3393918a4Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52246-570-04Spinosad1 in 1 CARTONSUSPENSION11
52246-570-04Spinosad120 mL in 1 BOTTLE, PLASTICSUSPENSION1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52246-570SPINOSAD SUSPENSION [PARAPRO LLC]1Current NDC, 2 package rows20240201_0d6e2507-3669-441e-b5ba-86087fd2955d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1085816spinosad 0.9 % Topical SuspensionPSN0d6e2507-3669-441e-b5ba-86087fd2955d1
1085816spinosad 9 MG/ML Medicated ShampooSCD0d6e2507-3669-441e-b5ba-86087fd2955d1
1085816spinosad 0.9 % Medicated ShampooSY0d6e2507-3669-441e-b5ba-86087fd2955d1
1085816spinosad 0.9 % Topical SuspensionSY0d6e2507-3669-441e-b5ba-86087fd2955d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
52246-570-04522460570041 BOTTLE, PLASTIC in 1 CARTON (52246-570-04) / 120 mL in 1 BOTTLE, PLASTIC2024-01-29NoNoCurrent