Home NDC 70621-101 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N208081-001 AMELUZ AMINOLEVULINIC ACID HYDROCHLORIDE 10% GEL / TOPICAL RLD, RS 2016-05-10
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208081-001 11540981 2028-02-07 Drug product 2023-01-18 N208081-001 11235169 2040-10-15 U-3303 2022-02-23 N208081-001 12280146 2043-12-08 Drug product 2025-05-20
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N208081-001 D-194 2027-10-04
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N208081-001 AMELUZ 10% GEL / TOPICAL RLD, RS 2016-05-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208081-001 AMELUZ 10% GEL / TOPICAL RLD, RS 2016-05-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208081-001 AMELUZ 10% GEL / TOPICAL RLD, RS 2016-05-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208081-001 AMELUZ 10% GEL / TOPICAL RLD, RS 2016-05-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208081-001 AMELUZ 10% GEL / TOPICAL RLD, RS 2016-05-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208081-001 AMELUZ 10% GEL / TOPICAL RLD, RS 2016-05-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208081-001 AMELUZ 10% GEL / TOPICAL RLD, RS 2016-05-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208081-001 AMELUZ 10% GEL / TOPICAL RLD, RS 2016-05-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208081-001 AMELUZ 10% GEL / TOPICAL RLD, RS 2016-05-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208081-001 AMELUZ 10% GEL / TOPICAL RLD, RS 2016-05-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208081-001 AMELUZ 10% GEL / TOPICAL RLD, RS 2016-05-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208081-001 AMELUZ 10% GEL / TOPICAL RLD, RS 2016-05-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208081-001 AMELUZ 10% GEL / TOPICAL RLD, RS 2016-05-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208081-001 AMELUZ 10% GEL / TOPICAL RLD, RS 2016-05-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208081-001 AMELUZ 10% GEL / TOPICAL RLD, RS 2016-05-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208081-001 AMELUZ 10% GEL / TOPICAL RLD, RS 2016-05-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208081-001 AMELUZ 10% GEL / TOPICAL RLD, RS 2016-05-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208081-001 AMELUZ 10% GEL / TOPICAL RLD, RS 2016-05-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208081-001 AMELUZ 10% GEL / TOPICAL RLD, RS 2016-05-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208081-001 AMELUZ 10% GEL / TOPICAL RLD, RS 2016-05-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208081-001 AMELUZ 10% GEL / TOPICAL RLD, RS 2016-05-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208081-001 AMELUZ 10% GEL / TOPICAL RLD, RS 2016-05-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208081-001 AMELUZ 10% GEL / TOPICAL RLD, RS 2016-05-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208081-001 AMELUZ 10% GEL / TOPICAL RLD, RS 2016-05-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208081-001 AMELUZ 10% GEL / TOPICAL RLD, RS 2016-05-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208081-001 AMELUZ 10% GEL / TOPICAL RLD, RS 2016-05-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208081-001 AMELUZ 10% GEL / TOPICAL RLD, RS 2016-05-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208081-001 AMELUZ 10% GEL / TOPICAL RLD, RS 2016-05-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208081-001 AMELUZ 10% GEL / TOPICAL RLD, RS 2016-05-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208081-001 AMELUZ 10% GEL / TOPICAL RLD, RS 2016-05-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208081-001 AMELUZ 10% GEL / TOPICAL RLD, RS 2016-05-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208081-001 AMELUZ 10% GEL / TOPICAL RLD, RS 2016-05-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208081-001 AMELUZ 10% GEL / TOPICAL RLD, RS 2016-05-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208081-001 AMELUZ 10% GEL / TOPICAL RLD, RS 2016-05-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208081-001 AMELUZ 10% GEL / TOPICAL RLD, RS 2016-05-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208081-001 AMELUZ 10% GEL / TOPICAL RLD, RS 2016-05-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208081-001 AMELUZ 10% GEL / TOPICAL RLD, RS 2016-05-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208081-001 AMELUZ 10% GEL / TOPICAL RLD, RS 2016-05-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208081-001 AMELUZ 10% GEL / TOPICAL RLD, RS 2016-05-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208081-001 AMELUZ 10% GEL / TOPICAL RLD, RS 2016-05-10 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 2 · 65 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N208081-001 11540981 2028-02-07 Drug product 2023-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208081-001 11235169 2040-10-15 U-3303 2022-02-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208081-001 12280146 2043-12-08 Drug product 2025-05-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208081-001 11540981 2028-02-07 Drug product 2023-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208081-001 11235169 2040-10-15 U-3303 2022-02-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208081-001 12280146 2043-12-08 Drug product 2025-05-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208081-001 11540981 2028-02-07 Drug product 2023-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208081-001 11235169 2040-10-15 U-3303 2022-02-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208081-001 12280146 2043-12-08 Drug product 2025-05-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208081-001 11540981 2028-02-07 Drug product 2023-01-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208081-001 11235169 2040-10-15 U-3303 2022-02-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208081-001 12280146 2043-12-08 Drug product 2025-05-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208081-001 11540981 2028-02-07 Drug product 2023-01-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208081-001 11235169 2040-10-15 U-3303 2022-02-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208081-001 11540981 2028-02-07 Drug product 2023-01-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208081-001 11235169 2040-10-15 U-3303 2022-02-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208081-001 11540981 2028-02-07 Drug product 2023-01-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208081-001 11235169 2040-10-15 U-3303 2022-02-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208081-001 11540981 2028-02-07 Drug product 2023-01-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208081-001 11235169 2040-10-15 U-3303 2022-02-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208081-001 11540981 2028-02-07 Drug product 2023-01-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208081-001 11235169 2040-10-15 U-3303 2022-02-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208081-001 11540981 2028-02-07 Drug product 2023-01-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208081-001 11235169 2040-10-15 U-3303 2022-02-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208081-001 11540981 2028-02-07 Drug product 2023-01-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N208081-001 11235169 2040-10-15 U-3303 2022-02-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208081-001 11540981 2028-02-07 Drug product 2023-01-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208081-001 11235169 2040-10-15 U-3303 2022-02-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208081-001 11540981 2028-02-07 Drug product 2023-01-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208081-001 11235169 2040-10-15 U-3303 2022-02-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208081-001 11540981 2028-02-07 Drug product 2023-01-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208081-001 11235169 2040-10-15 U-3303 2022-02-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208081-001 11540981 2028-02-07 Drug product 2023-01-18 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N208081-001 11235169 2040-10-15 U-3303 2022-02-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208081-001 11235169 2040-10-15 U-3303 2022-02-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208081-001 11235169 2040-10-15 U-3303 2022-02-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208081-001 11235169 2040-10-15 U-3303 2022-02-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208081-001 6559183 2019-11-12 U-804 Drug product 2016-10-07 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N208081-001 6559183 2019-11-12 U-804 Drug product 2016-10-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208081-001 6559183 2019-11-12 U-804 Drug product 2016-10-07 b00525d2431f…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base AMELUZ
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMINOLEVULINIC ACID HYDROCHLORIDE 100 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V35KBM8JGR Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1806645 Internal RxNorm lookup 1806650 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70621-101 AMELUZ (AMINOLEVULINIC ACID HYDROCHLORIDE) GEL [BIOFRONTERA INC.] 29 Current NDC, Legacy NDC, 5 package rows 20250418_650daa9f-aeec-49ce-95b9-5fa20b988afd.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join AMELUZ AMINOLEVULINIC ACID HYDROCHLORIDE Biofrontera Inc. 650daa9f-aeec-49ce-95b9-5fa20b988afd 2026-07-23 Warnings, Adverse reactions Exact identifier application applno (NDA): 208081 application number: NDA208081 ndc (product): 70621-101
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70621-101-01 70621010101 2 g in 1 TUBE 2 g Historical 70621-101-03 70621010103 2 g in 1 TUBE 2 g Historical 70621-101-10 70621010110 1 TUBE in 1 PACKAGE (70621-101-10) / 2 g in 1 TUBE (70621-101-01) 1 tube 2017-06-01 0000-00-00 No No Current 70621-101-20 70621010120 10 TUBE in 1 PACKAGE (70621-101-20) / 2 g in 1 TUBE (70621-101-01) 10 tube 2021-05-10 0000-00-00 No No Current 70621-101-30 70621010130 1 TUBE in 1 PACKAGE (70621-101-30) / 2 g in 1 TUBE (70621-101-03) 1 tube 2017-06-01 0000-00-00 Yes No Current