Home NDC 59137-231 GLEOLAN
Product NDC 59137-231
11-digit product format 591370231
Labeler code 59137
Product ID 59137-231_425c0da5-cec7-4a38-88ee-b230c0601f51
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name AMINOLEVULINIC ACID HYDROCHLORIDE
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Medexus Pharma, Inc.
Application NDA208630
Marketing category NDA
Marketing start 2018-04-14
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 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 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 Product TE source text 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# DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59137-231-01 GLEOLAN 1 in 1 VIAL, SINGLE-DOSE POWDER, FOR SOLUTION 1 3 59137-231-01 GLEOLAN 1 in 1 CARTON POWDER, FOR SOLUTION 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59137-231 GLEOLAN (AMINOLEVULINIC ACID HYDROCHLORIDE) POWDER, FOR SOLUTION [MEDEXUS PHARMA, INC.] 3 Current NDC, Legacy NDC, 2 package rows 20240507_4873911e-a5d7-47e3-9679-fa5c95999323.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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 59137-231-01 59137023101 1 VIAL, SINGLE-DOSE in 1 CARTON (59137-231-01) / 1 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE 2022-03-01 0000-00-00 No No Current