Malathion

Product NDC
51672-5294
11-digit product format
516725294
Labeler code
51672
Product ID
51672-5294_48601e44-5f35-5e10-e063-6394a90a5801
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Malathion
Dosage form
LOTION
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA091559
Marketing category
ANDA
Marketing start
2014-01-31
Substance
MALATHION
Active strength
.0005 g/mL
Pharmacologic classes
Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MALATHION.0005 g/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU5N7SU872W

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6d2da11d-2f7e-d69f-1620-73a34452e2e3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-5294-4Malathion1 in 1 CARTONLOTION13
51672-5294-4Malathion59 mL in 1 BOTTLELOTION593

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-5294-4ML - Milliliter51672-5294692d1c9a-3f55-4af5-8a18-04dd73ac505d12014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MalathionACTIVE INGREDIENTU5N7SU872WMALATHION LOTION [TARO PHARMACEUTICALS U.S.A., INC.]1
MalathionACTIVE MOIETYU5N7SU872WMALATHION LOTION [TARO PHARMACEUTICALS U.S.A., INC.]1
isopropyl alcoholINACTIVE INGREDIENTND2M416302MALATHION LOTION [TARO PHARMACEUTICALS U.S.A., INC.]1
limonene, (+/-)-INACTIVE INGREDIENT9MC3I34447MALATHION LOTION [TARO PHARMACEUTICALS U.S.A., INC.]1
pine needle oil (pinus sylvestris)INACTIVE INGREDIENT5EXL5H740YMALATHION LOTION [TARO PHARMACEUTICALS U.S.A., INC.]1
terpineolINACTIVE INGREDIENTR53Q4ZWC99MALATHION LOTION [TARO PHARMACEUTICALS U.S.A., INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-5294MALATHION LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2Current NDC, Legacy NDC, 2 package rows20180720_a0b1444b-f51b-44fd-8f23-2fff49b64bc0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-5294-4516725294041 BOTTLE in 1 CARTON (51672-5294-4) / 59 mL in 1 BOTTLE1 bottle2014-01-310000-00-00NoNoCurrent