AMELUZ

Product NDC: 70621-101
11-digit product format: 706210101
Labeler code: 70621
Product ID: 70621-101_35abf34b-efce-46da-8737-9795c8e2ed7b
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N208081-001	AMELUZ	10%	GEL / TOPICAL	RLD, RS	2016-05-10	`84e616aacf4f…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N208081-001	11540981	2028-02-07		Drug product	2023-01-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208081-001	11235169	2040-10-15	U-3303		2022-02-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208081-001	12280146	2043-12-08		Drug product	2025-05-20	`84e616aacf4f…`
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…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N208081-001	D-194	2027-10-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208081-001	D-194	2027-10-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208081-001	D-194	2027-10-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208081-001	D-194	2027-10-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208081-001	D-194	2027-10-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208081-001	D-194	2027-10-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208081-001	D-194	2027-10-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208081-001	D-194	2027-10-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208081-001	D-194	2027-10-04	`2680178bc6a6…`
2019-12-13 00:20 UTC	2019-12	N208081-001	NP	2019-05-10	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N208081-001	NP	2019-05-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208081-001	NP	2019-05-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208081-001	NP	2019-05-10	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208081-001	D-194	2027-10-04	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c09e7fc3-90f5-4f9d-96f4-e1a857de4102	Product name	1	20230718
36aa7500-f1f6-4316-9cf2-688d1cdea23a	Product name	1	20190402
15592b85-0e03-4d08-b78d-bef98f30a3f5	Product name	1	20180529

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70621-101-01	AMELUZ	2 g in 1 TUBE	GEL	2	31
70621-101-03	AMELUZ	2 g in 1 TUBE	GEL	2	31
70621-101-10	AMELUZ	1 in 1 PACKAGE	GEL	1	31
70621-101-20	AMELUZ	10 in 1 PACKAGE	GEL	10	31
70621-101-30	AMELUZ	1 in 1 PACKAGE	GEL	1	31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70621-101-01	GM - Gram	70621-101	da1ef119-6658-4911-bd73-e37b1c7be8f3	1	2016-11-08
70621-101-10	GM - Gram	70621-101	9f3c1b6b-db39-4108-aef1-8f7eb907844b	1	2019-05-02
70621-101-20	GM - Gram	70621-101	d4402acc-5bb5-400e-9439-d3f05a9fea6f	1	2022-04-06
70621-101-30	GM - Gram	70621-101	76350f04-0fd0-4a15-9c45-64d5b8b85a75	1	2019-05-02

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V35KBM8JGR	AMINOLEVULINIC ACID HYDROCHLORIDE	5451-09-2	AMINOLEVULINIC ACID HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1806650	Ameluz 10 % Topical Gel	PSN	650daa9f-aeec-49ce-95b9-5fa20b988afd	31
1806645	aminolevulinic acid HCl 10 % Topical Gel	PSN	650daa9f-aeec-49ce-95b9-5fa20b988afd	31
1806650	aminolevulinic acid hydrochloride 0.1 MG/MG Topical Gel [Ameluz]	SBD	650daa9f-aeec-49ce-95b9-5fa20b988afd	31
1806645	aminolevulinic acid hydrochloride 0.1 MG/MG Topical Gel	SCD	650daa9f-aeec-49ce-95b9-5fa20b988afd	31
1806650	Ameluz 0.1 MG/MG Topical Gel	SY	650daa9f-aeec-49ce-95b9-5fa20b988afd	31
1806650	Ameluz 10 % Topical Gel	SY	650daa9f-aeec-49ce-95b9-5fa20b988afd	31
1806645	aminolevulinic acid hydrochloride 10 % Topical Gel	SY	650daa9f-aeec-49ce-95b9-5fa20b988afd	31

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