Spinosad

Product NDC
84635-570
11-digit product format
846350570
Labeler code
84635
Product ID
84635-570_4c375471-7b53-757f-e063-6294a90a8065
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
spinosad
Dosage form
SUSPENSION
Route
TOPICAL
Labeler
Cipher Pharmaceuticals Inc.
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Spinosad
Listing expiration
2027-12-31

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
84635-570-04Spinosad120 mL in 1 BOTTLE, PLASTICSUSPENSION1202
84635-570-04Spinosad1 in 1 CARTONSUSPENSION12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1085816spinosad 0.9 % Topical SuspensionPSN16a95039-0df7-45d5-8b51-bbc81443fea32
1085816spinosad 9 MG/ML Medicated ShampooSCD16a95039-0df7-45d5-8b51-bbc81443fea32
1085816spinosad 0.9 % Medicated ShampooSY16a95039-0df7-45d5-8b51-bbc81443fea32
1085816spinosad 0.9 % Topical SuspensionSY16a95039-0df7-45d5-8b51-bbc81443fea32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
84635-570-04846350570041 BOTTLE, PLASTIC in 1 CARTON (84635-570-04) / 120 mL in 1 BOTTLE, PLASTIC2026-01-19NoNoCurrent