FDA.reportPublic FDA data

AMELUZ

Product NDC
70621-101
11-digit product format
706210101
Labeler code
70621
Product ID
70621-101_ca974f80-1bb2-4932-a651-d085020a8b57
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
aminolevulinic acid hydrochloride
Dosage form
GEL
Route
TOPICAL
Labeler
Biofrontera Inc.
Application
NDA208081
Marketing category
NDA
Marketing start
2016-08-26
Substance
AMINOLEVULINIC ACID HYDROCHLORIDE
Active strength
100 mg/g
Pharmacologic classes
Fluorescence Contrast Activity [MoA], Optical Imaging Agent [EPC], Porphyrin Precursor [EPC], Porphyrinogens [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AMELUZ
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMINOLEVULINIC ACID HYDROCHLORIDE100 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV35KBM8JGR
Rxcui1806645, 1806650

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
70621-101-01AMELUZ2 g in 1 TUBEGEL231
70621-101-03AMELUZ2 g in 1 TUBEGEL231
70621-101-10AMELUZ1 in 1 PACKAGEGEL131
70621-101-20AMELUZ10 in 1 PACKAGEGEL1031
70621-101-30AMELUZ1 in 1 PACKAGEGEL131

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70621-101-01GM - Gram70621-101da1ef119-6658-4911-bd73-e37b1c7be8f312016-11-08
70621-101-10GM - Gram70621-1019f3c1b6b-db39-4108-aef1-8f7eb907844b12019-05-02
70621-101-20GM - Gram70621-101d4402acc-5bb5-400e-9439-d3f05a9fea6f12022-04-06
70621-101-30GM - Gram70621-10176350f04-0fd0-4a15-9c45-64d5b8b85a7512019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70621-101AMELUZ (AMINOLEVULINIC ACID HYDROCHLORIDE) GEL [BIOFRONTERA INC.]29Current NDC, Legacy NDC, 5 package rows20250418_650daa9f-aeec-49ce-95b9-5fa20b988afd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1806650Ameluz 10 % Topical GelPSN650daa9f-aeec-49ce-95b9-5fa20b988afd31
1806645aminolevulinic acid HCl 10 % Topical GelPSN650daa9f-aeec-49ce-95b9-5fa20b988afd31
1806650aminolevulinic acid hydrochloride 0.1 MG/MG Topical Gel [Ameluz]SBD650daa9f-aeec-49ce-95b9-5fa20b988afd31
1806645aminolevulinic acid hydrochloride 0.1 MG/MG Topical GelSCD650daa9f-aeec-49ce-95b9-5fa20b988afd31
1806650Ameluz 0.1 MG/MG Topical GelSY650daa9f-aeec-49ce-95b9-5fa20b988afd31
1806650Ameluz 10 % Topical GelSY650daa9f-aeec-49ce-95b9-5fa20b988afd31
1806645aminolevulinic acid hydrochloride 10 % Topical GelSY650daa9f-aeec-49ce-95b9-5fa20b988afd31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70621-101-01706210101012 g in 1 TUBE2 gHistorical
70621-101-03706210101032 g in 1 TUBE2 gHistorical
70621-101-10706210101101 TUBE in 1 PACKAGE (70621-101-10) / 2 g in 1 TUBE (70621-101-01) 1 tube2017-06-010000-00-00NoNoCurrent
70621-101-207062101012010 TUBE in 1 PACKAGE (70621-101-20) / 2 g in 1 TUBE (70621-101-01) 10 tube2021-05-100000-00-00NoNoCurrent
70621-101-30706210101301 TUBE in 1 PACKAGE (70621-101-30) / 2 g in 1 TUBE (70621-101-03) 1 tube2017-06-010000-00-00YesNoCurrent