FDA.reportPublic FDA data

GLEOLAN

Product NDC
71469-231
11-digit product format
714690231
Labeler code
71469
Product ID
71469-231_957499a8-90f5-4cbd-916d-abfd8251e1b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMINOLEVULINIC ACID HYDROCHLORIDE
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
NX DEVELOPMENT CORP
Application
NDA208630
Marketing category
NDA
Marketing start
2018-03-14
Substance
AMINOLEVULINIC ACID HYDROCHLORIDE
Active strength
1500 mg/1
Pharmacologic classes
Fluorescence Contrast Activity [MoA], Optical Imaging Agent [EPC], Porphyrin Precursor [EPC], Porphyrinogens [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMINOLEVULINIC ACID HYDROCHLORIDE1500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV35KBM8JGR

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71469-231-012025-02-12C16284748780-1ba0f9c33-584a-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GLEOLAN safely and effectively. See full prescribing information for GLEOLAN. GLEOLAN ® (aminolevulinic acid hydrochloride) for oral solution Initial U.S. Approval: [1999]
71469-231-012023-01-30C16284748780-1ba0f9c33-584a-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GLEOLAN safely and effectively. See full prescribing information for GLEOLAN. GLEOLAN ® (aminolevulinic acid hydrochloride) for oral solution Initial U.S. Approval: [1999]
71469-231-012021-03-04C16284748780-1ba0f9c33-584a-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GLEOLAN safely and effectively. See full prescribing information for GLEOLAN. GLEOLAN ® (aminolevulinic acid hydrochloride) for oral solution Initial U.S. Approval: [1999]
71469-231-012021-01-29C16284748780-1ba0f9c33-584a-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GLEOLAN safely and effectively. See full prescribing information for GLEOLAN. GLEOLAN ® (aminolevulinic acid hydrochloride) for oral solution Initial U.S. Approval: [1999]

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71469-231-01GLEOLAN1 in 1 CARTONPOWDER, FOR SOLUTION18
71469-231-01GLEOLAN1 in 1 VIAL, SINGLE-DOSEPOWDER, FOR SOLUTION18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71469-231-01EA - Each71469-23129b38612-48b9-476a-88bb-7e0e63eacf4822019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71469-231GLEOLAN (AMINOLEVULINIC ACID HYDROCHLORIDE) POWDER, FOR SOLUTION [NX DEVELOPMENT CORP]7Current NDC, Legacy NDC, 2 package rows20250214_cdeded66-0017-42cf-9471-13f231014323.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71469-231-01714690231011 VIAL, SINGLE-DOSE in 1 CARTON (71469-231-01) / 1 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE2018-03-140000-00-00NoNoCurrent