Natroba

Product NDC
52246-929
11-digit product format
522460929
Labeler code
52246
Product ID
52246-929_e37c79d5-e9c4-4ee5-870a-b44000f03748
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
spinosad
Dosage form
SUSPENSION
Route
TOPICAL
Labeler
ParaPRO LLC
Application
NDA022408
Marketing category
NDA
Marketing start
2011-01-25
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
Natroba
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SPINOSAD9 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiXPA88EAP6V
Rxcui1085816, 1085820

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
52246-929-04Natroba120 mL in 1 BOTTLE, PLASTICSUSPENSION12010
52246-929-04Natroba1 in 1 CARTONSUSPENSION110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52246-929-04ML - Milliliter52246-929e46695b7-6ee9-49c4-9349-572bbe475f6a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
spinosadACTIVE INGREDIENTXPA88EAP6VNATROBA (SPINOSAD) SUSPENSION [PARAPRO LLC]6
spinosadACTIVE MOIETYXPA88EAP6VNATROBA (SPINOSAD) SUSPENSION [PARAPRO LLC]6
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHNATROBA (SPINOSAD) SUSPENSION [PARAPRO LLC]6
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KNATROBA (SPINOSAD) SUSPENSION [PARAPRO LLC]6
CETETH-20INACTIVE INGREDIENTI835H2IHHXNATROBA (SPINOSAD) SUSPENSION [PARAPRO LLC]6
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SNATROBA (SPINOSAD) SUSPENSION [PARAPRO LLC]6
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NATROBA (SPINOSAD) SUSPENSION [PARAPRO LLC]6
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75JNATROBA (SPINOSAD) SUSPENSION [PARAPRO LLC]6
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)INACTIVE INGREDIENTS38J6RZN16NATROBA (SPINOSAD) SUSPENSION [PARAPRO LLC]6
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302NATROBA (SPINOSAD) SUSPENSION [PARAPRO LLC]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NATROBA (SPINOSAD) SUSPENSION [PARAPRO LLC]6
STEARALKONIUM CHLORIDEINACTIVE INGREDIENT0OUO26BB88NATROBA (SPINOSAD) SUSPENSION [PARAPRO LLC]6
WATERINACTIVE INGREDIENT059QF0KO0RNATROBA (SPINOSAD) SUSPENSION [PARAPRO LLC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52246-929NATROBA (SPINOSAD) SUSPENSION [PARAPRO LLC]10Current NDC, Legacy NDC, 2 package rows20210501_fa90ccc8-2df0-49f7-8878-2b33e34cd272.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1085820Natroba 0.9 % Topical SuspensionPSNfa90ccc8-2df0-49f7-8878-2b33e34cd27210
1085816spinosad 0.9 % Topical SuspensionPSNfa90ccc8-2df0-49f7-8878-2b33e34cd27210
1085820spinosad 9 MG/ML Medicated Shampoo [Natroba]SBDfa90ccc8-2df0-49f7-8878-2b33e34cd27210
1085816spinosad 9 MG/ML Medicated ShampooSCDfa90ccc8-2df0-49f7-8878-2b33e34cd27210
1085820Natroba 0.9 % Topical SuspensionSYfa90ccc8-2df0-49f7-8878-2b33e34cd27210
1085820Natroba 9 MG/ML Medicated ShampooSYfa90ccc8-2df0-49f7-8878-2b33e34cd27210
1085816spinosad 0.9 % Medicated ShampooSYfa90ccc8-2df0-49f7-8878-2b33e34cd27210
1085816spinosad 0.9 % Topical SuspensionSYfa90ccc8-2df0-49f7-8878-2b33e34cd27210

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52246-929-04522460929041 BOTTLE, PLASTIC in 1 CARTON (52246-929-04) / 120 mL in 1 BOTTLE, PLASTIC2011-01-250000-00-00NoNoCurrent