FDA.reportPublic FDA data

LEVULAN KERASTICK

Product NDC
67308-101
11-digit product format
673080101
Labeler code
67308
Product ID
67308-101_21ef2c6b-8abc-8bcf-e063-6294a90ae9e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
aminolevulinic acid hydrochloride
Dosage form
KIT
Labeler
Sun Pharmaceutical Industries, Inc
Application
NDA020965
Marketing category
NDA
Marketing start
2000-09-04
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c09e7fc3-90f5-4f9d-96f4-e1a857de4102Product name120230718
36aa7500-f1f6-4316-9cf2-688d1cdea23aProduct name120190402
15592b85-0e03-4d08-b78d-bef98f30a3f5Product name120180529

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67308-101-01LEVULAN KERASTICK1 in 1 APPLICATORKIT121
67308-101-02LEVULAN KERASTICK2 in 1 CARTONKIT221
67308-101-06LEVULAN KERASTICK6 in 1 CARTONKIT621

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67308-101-01EA - Each67308-101658f179c-52dc-460f-872e-be078412e3fb12012-07-24
67308-101-06EA - Each67308-1014b0f9c01-449d-4152-8e38-07c102e2e75412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Aminolevulinic Acid HydrochlorideACTIVE INGREDIENTV35KBM8JGRLEVULAN KERASTICK (AMINOLEVULINIC ACID HYDROCHLORIDE) KIT [DUSA PHARMACEUTICALS, INC.]4
Aminolevulinic AcidACTIVE MOIETY88755TAZ87LEVULAN KERASTICK (AMINOLEVULINIC ACID HYDROCHLORIDE) KIT [DUSA PHARMACEUTICALS, INC.]4
AlcoholINACTIVE INGREDIENT3K9958V90MLEVULAN KERASTICK (AMINOLEVULINIC ACID HYDROCHLORIDE) KIT [DUSA PHARMACEUTICALS, INC.]4
Isopropyl AlcoholINACTIVE INGREDIENTND2M416302LEVULAN KERASTICK (AMINOLEVULINIC ACID HYDROCHLORIDE) KIT [DUSA PHARMACEUTICALS, INC.]4
Laureth-4INACTIVE INGREDIENT6HQ855798JLEVULAN KERASTICK (AMINOLEVULINIC ACID HYDROCHLORIDE) KIT [DUSA PHARMACEUTICALS, INC.]4
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1ALEVULAN KERASTICK (AMINOLEVULINIC ACID HYDROCHLORIDE) KIT [DUSA PHARMACEUTICALS, INC.]4
WaterINACTIVE INGREDIENT059QF0KO0RLEVULAN KERASTICK (AMINOLEVULINIC ACID HYDROCHLORIDE) KIT [DUSA PHARMACEUTICALS, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67308-101LEVULAN KERASTICK (AMINOLEVULINIC ACID HYDROCHLORIDE) KIT [SUN PHARMACEUTICAL INDUSTRIES, INC]21Current NDC, Legacy NDC, 3 package rows20240913_e45cc371-9ebc-4904-12bc-65cb4e2817ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
762672aminolevulinic acid HCl 20 % Topical SolutionPSNe45cc371-9ebc-4904-12bc-65cb4e2817ad21
762674Levulan Kerastick 20 % Topical SolutionPSNe45cc371-9ebc-4904-12bc-65cb4e2817ad21
762674aminolevulinate 200 MG/ML Topical Solution [Levulan]SBDe45cc371-9ebc-4904-12bc-65cb4e2817ad21
762672aminolevulinate 200 MG/ML Topical SolutionSCDe45cc371-9ebc-4904-12bc-65cb4e2817ad21
762672aminolevulinate 20 % Topical SolutionSYe45cc371-9ebc-4904-12bc-65cb4e2817ad21
762674Levulan 200 MG/ML Topical SolutionSYe45cc371-9ebc-4904-12bc-65cb4e2817ad21
762674Levulan Kerastick 20 % Topical SolutionSYe45cc371-9ebc-4904-12bc-65cb4e2817ad21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67308-101-01673080101011 KIT in 1 APPLICATOR (67308-101-01) * 1.5 mL in 1 AMPULE * 1.5 mL in 1 AMPULE1 kit2000-09-040000-00-00NoNoCurrent
67308-101-02673080101022 APPLICATOR in 1 CARTON (67308-101-02) / 1 KIT in 1 APPLICATOR (67308-101-01) * 1.5 mL in 1 AMPULE * 1.5 mL in 1 AMPULE2 applicator2000-12-200000-00-00NoNoCurrent
67308-101-06673080101066 APPLICATOR in 1 CARTON (67308-101-06) / 1 KIT in 1 APPLICATOR (67308-101-01) * 1.5 mL in 1 AMPULE * 1.5 mL in 1 AMPULE6 applicator2000-09-240000-00-00NoNoCurrent