GLEOLAN

Product NDC: 71469-231
Requested package NDC: 71469-231-01
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
N208630-001	GLEOLAN	AMINOLEVULINIC ACID HYDROCHLORIDE	1.5GM/VIAL	FOR SOLUTION / ORAL		RLD, RS	2017-06-06

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N208630-001	GLEOLAN	1.5GM/VIAL	FOR SOLUTION / ORAL	RLD, RS	2017-06-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208630-001	GLEOLAN	1.5GM/VIAL	FOR SOLUTION / ORAL	RLD, RS	2017-06-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208630-001	GLEOLAN	1.5GM/VIAL	FOR SOLUTION / ORAL	RLD, RS	2017-06-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208630-001	GLEOLAN	1.5GM/VIAL	FOR SOLUTION / ORAL	RLD, RS	2017-06-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208630-001	GLEOLAN	1.5GM/VIAL	FOR SOLUTION / ORAL	RLD, RS	2017-06-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208630-001	GLEOLAN	1.5GM/VIAL	FOR SOLUTION / ORAL	RLD, RS	2017-06-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208630-001	GLEOLAN	1.5GM/VIAL	FOR SOLUTION / ORAL	RLD, RS	2017-06-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208630-001	GLEOLAN	1.5GM/VIAL	FOR SOLUTION / ORAL	RLD, RS	2017-06-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208630-001	GLEOLAN	1.5GM/VIAL	FOR SOLUTION / ORAL	RLD, RS	2017-06-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208630-001	GLEOLAN	1.5GM/VIAL	FOR SOLUTION / ORAL	RLD, RS	2017-06-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208630-001	GLEOLAN	1.5GM/VIAL	FOR SOLUTION / ORAL	RLD, RS	2017-06-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208630-001	GLEOLAN	1.5GM/VIAL	FOR SOLUTION / ORAL	RLD, RS	2017-06-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208630-001	GLEOLAN	1.5GM/VIAL	FOR SOLUTION / ORAL	RLD, RS	2017-06-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208630-001	GLEOLAN	1.5GM/VIAL	FOR SOLUTION / ORAL	RLD, RS	2017-06-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208630-001	GLEOLAN	1.5GM/VIAL	FOR SOLUTION / ORAL	RLD, RS	2017-06-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208630-001	GLEOLAN	1.5GM/VIAL	FOR SOLUTION / ORAL	RLD, RS	2017-06-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208630-001	GLEOLAN	1.5GM/VIAL	FOR SOLUTION / ORAL	RLD, RS	2017-06-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208630-001	GLEOLAN	1.5GM/VIAL	FOR SOLUTION / ORAL	RLD, RS	2017-06-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208630-001	GLEOLAN	1.5GM/VIAL	FOR SOLUTION / ORAL	RLD, RS	2017-06-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208630-001	GLEOLAN	1.5GM/VIAL	FOR SOLUTION / ORAL	RLD, RS	2017-06-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208630-001	GLEOLAN	1.5GM/VIAL	FOR SOLUTION / ORAL	RLD, RS	2017-06-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208630-001	GLEOLAN	1.5GM/VIAL	FOR SOLUTION / ORAL	RLD, RS	2017-06-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208630-001	GLEOLAN	1.5GM/VIAL	FOR SOLUTION / ORAL	RLD, RS	2017-06-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208630-001	GLEOLAN	1.5GM/VIAL	FOR SOLUTION / ORAL	RLD, RS	2017-06-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208630-001	GLEOLAN	1.5GM/VIAL	FOR SOLUTION / ORAL	RLD, RS	2017-06-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208630-001	GLEOLAN	1.5GM/VIAL	FOR SOLUTION / ORAL	RLD, RS	2017-06-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208630-001	GLEOLAN	1.5GM/VIAL	FOR SOLUTION / ORAL	RLD, RS	2017-06-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208630-001	GLEOLAN	1.5GM/VIAL	FOR SOLUTION / ORAL	RLD, RS	2017-06-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208630-001	GLEOLAN	1.5GM/VIAL	FOR SOLUTION / ORAL	RLD, RS	2017-06-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208630-001	GLEOLAN	1.5GM/VIAL	FOR SOLUTION / ORAL	RLD, RS	2017-06-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208630-001	GLEOLAN	1.5GM/VIAL	FOR SOLUTION / ORAL	RLD, RS	2017-06-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208630-001	GLEOLAN	1.5GM/VIAL	FOR SOLUTION / ORAL	RLD, RS	2017-06-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208630-001	GLEOLAN	1.5GM/VIAL	FOR SOLUTION / ORAL	RLD, RS	2017-06-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208630-001	GLEOLAN	1.5GM/VIAL	FOR SOLUTION / ORAL	RLD, RS	2017-06-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208630-001	GLEOLAN	1.5GM/VIAL	FOR SOLUTION / ORAL	RLD, RS	2017-06-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208630-001	GLEOLAN	1.5GM/VIAL	FOR SOLUTION / ORAL	RLD, RS	2017-06-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208630-001	GLEOLAN	1.5GM/VIAL	FOR SOLUTION / ORAL	RLD, RS	2017-06-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208630-001	GLEOLAN	1.5GM/VIAL	FOR SOLUTION / ORAL	RLD, RS	2017-06-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208630-001	GLEOLAN	1.5GM/VIAL	FOR SOLUTION / ORAL	RLD, RS	2017-06-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208630-001	GLEOLAN	1.5GM/VIAL	FOR SOLUTION / ORAL	RLD, RS	2017-06-06	`e64feba35796…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208630-001	ODE-146	2024-06-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208630-001	ODE-146	2024-06-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208630-001	ODE-146	2024-06-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208630-001	ODE-146	2024-06-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208630-001	ODE-146	2024-06-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208630-001	ODE-146	2024-06-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208630-001	ODE-146	2024-06-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208630-001	ODE-146	2024-06-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208630-001	ODE-146	2024-06-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208630-001	ODE-146	2024-06-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208630-001	ODE-146	2024-06-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208630-001	ODE-146	2024-06-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208630-001	ODE-146	2024-06-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208630-001	ODE-146	2024-06-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208630-001	ODE-146	2024-06-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208630-001	ODE-146	2024-06-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208630-001	ODE-146	2024-06-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208630-001	ODE-146	2024-06-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208630-001	ODE-146	2024-06-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208630-001	ODE-146	2024-06-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208630-001	ODE-146	2024-06-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208630-001	ODE-146	2024-06-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208630-001	ODE-146	2024-06-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208630-001	ODE-146	2024-06-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208630-001	ODE-146	2024-06-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208630-001	ODE-146	2024-06-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208630-001	ODE-146	2024-06-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208630-001	ODE-146	2024-06-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208630-001	ODE-146	2024-06-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208630-001	ODE-146	2024-06-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208630-001	ODE-146	2024-06-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208630-001	ODE-146	2024-06-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208630-001	ODE-146	2024-06-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208630-001	ODE-146	2024-06-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208630-001	ODE-146	2024-06-06	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMINOLEVULINIC ACID HYDROCHLORIDE	1500 mg/1

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 SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
cdeded66-0017-42cf-9471-13f231014323	Available on FDA.report

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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-02-12	These 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]
2023-01-30	These 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]
2021-03-04	These 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]
2021-01-29	These 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 NDC	Product	Description	Form	Quantity	Strength	SPL version
71469-231-01	GLEOLAN	1 in 1 CARTON	POWDER, FOR SOLUTION	1		8
71469-231-01	GLEOLAN	1 in 1 VIAL, SINGLE-DOSE	POWDER, FOR SOLUTION	1		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71469-231-01	EA - Each	71469-231	29b38612-48b9-476a-88bb-7e0e63eacf48	2	2019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71469-231	GLEOLAN (AMINOLEVULINIC ACID HYDROCHLORIDE) POWDER, FOR SOLUTION [NX DEVELOPMENT CORP]	7	Current NDC, Legacy NDC, 2 package rows	20250214_cdeded66-0017-42cf-9471-13f231014323.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
GLEOLAN	AMINOLEVULINIC ACID HYDROCHLORIDE	NX DEVELOPMENT CORP	cdeded66-0017-42cf-9471-13f231014323	2026-01-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208630 application number: NDA208630 ndc (package): 71469-231-01 ndc (product): 71469-231 ndc11 (package): 71469023101

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71469-231-01	71469023101	1 VIAL, SINGLE-DOSE in 1 CARTON (71469-231-01) / 1 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE	2018-03-14	0000-00-00	No	No	Current