Home NDC 67308-101-01 LEVULAN KERASTICK
Product NDC 67308-101
Requested package NDC 67308-101-01
11-digit product format 673080101
Labeler code 67308
Product ID 67308-101_21ef2c6b-8abc-8bcf-e063-6294a90ae9e1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name aminolevulinic acid hydrochloride
Dosage form KIT
Labeler Sun Pharmaceutical Industries, Inc
Application NDA020965
Marketing category NDA
Marketing start 2000-09-04
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 1 .
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 N020965-001 LEVULAN AMINOLEVULINIC ACID HYDROCHLORIDE 20% SOLUTION / TOPICAL RLD, RS 1999-12-03
Orange Book patents# Current patent rows page 1 of 1 · 10 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N020965-001 11179574 2036-10-13 U-804 2025-05-30 N020965-001 11697028 2036-10-13 U-804 2025-05-30 N020965-001 12290700 2036-10-13 U-804 2025-05-30 N020965-001 11446512 2037-01-17 U-804 2025-05-30 N020965-001 10357567 2038-01-12 U-3163 2019-08-02 N020965-001 11077192 2038-01-12 U-3163 2021-08-11 N020965-001 11135293 2038-01-12 U-3163 2021-10-19 N020965-001 11571478 2038-01-12 U-3163 2023-06-14 N020965-001 11690914 2038-01-12 U-3163 2023-07-14 N020965-001 12296011 2038-01-12 U-3163 2025-06-06
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 · 41 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 2026-02-19 14:30 UTC 2026-02 N020965-001 LEVULAN 20% SOLUTION / TOPICAL RLD, RS 1999-12-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020965-001 LEVULAN 20% SOLUTION / TOPICAL RLD, RS 1999-12-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020965-001 LEVULAN 20% SOLUTION / TOPICAL RLD, RS 1999-12-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020965-001 LEVULAN 20% SOLUTION / TOPICAL RLD, RS 1999-12-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020965-001 LEVULAN 20% SOLUTION / TOPICAL RLD, RS 1999-12-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020965-001 LEVULAN 20% SOLUTION / TOPICAL RLD, RS 1999-12-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020965-001 LEVULAN 20% SOLUTION / TOPICAL RLD, RS 1999-12-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020965-001 LEVULAN 20% SOLUTION / TOPICAL RLD, RS 1999-12-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020965-001 LEVULAN 20% SOLUTION / TOPICAL RLD, RS 1999-12-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020965-001 LEVULAN 20% SOLUTION / TOPICAL RLD, RS 1999-12-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020965-001 LEVULAN 20% SOLUTION / TOPICAL RLD, RS 1999-12-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020965-001 LEVULAN 20% SOLUTION / TOPICAL RLD, RS 1999-12-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020965-001 LEVULAN 20% SOLUTION / TOPICAL RLD, RS 1999-12-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020965-001 LEVULAN 20% SOLUTION / TOPICAL RLD, RS 1999-12-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020965-001 LEVULAN 20% SOLUTION / TOPICAL RLD, RS 1999-12-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020965-001 LEVULAN 20% SOLUTION / TOPICAL RLD, RS 1999-12-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020965-001 LEVULAN 20% SOLUTION / TOPICAL RLD, RS 1999-12-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020965-001 LEVULAN 20% SOLUTION / TOPICAL RLD, RS 1999-12-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020965-001 LEVULAN 20% SOLUTION / TOPICAL RLD, RS 1999-12-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020965-001 LEVULAN 20% SOLUTION / TOPICAL RLD, RS 1999-12-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020965-001 LEVULAN 20% SOLUTION / TOPICAL RLD, RS 1999-12-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020965-001 LEVULAN 20% SOLUTION / TOPICAL RLD, RS 1999-12-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020965-001 LEVULAN 20% SOLUTION / TOPICAL RLD, RS 1999-12-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020965-001 LEVULAN 20% SOLUTION / TOPICAL RLD, RS 1999-12-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020965-001 LEVULAN 20% SOLUTION / TOPICAL RLD, RS 1999-12-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020965-001 LEVULAN 20% SOLUTION / TOPICAL RLD, RS 1999-12-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020965-001 LEVULAN 20% SOLUTION / TOPICAL RLD, RS 1999-12-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020965-001 LEVULAN 20% SOLUTION / TOPICAL RLD, RS 1999-12-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020965-001 LEVULAN 20% SOLUTION / TOPICAL RLD, RS 1999-12-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020965-001 LEVULAN 20% SOLUTION / TOPICAL RLD, RS 1999-12-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020965-001 LEVULAN 20% SOLUTION / TOPICAL RLD, RS 1999-12-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020965-001 LEVULAN 20% SOLUTION / TOPICAL RLD, RS 1999-12-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020965-001 LEVULAN 20% SOLUTION / TOPICAL RLD, RS 1999-12-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020965-001 LEVULAN 20% SOLUTION / TOPICAL RLD, RS 1999-12-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020965-001 LEVULAN 20% SOLUTION / TOPICAL RLD, RS 1999-12-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020965-001 LEVULAN 20% SOLUTION / TOPICAL RLD, RS 1999-12-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020965-001 LEVULAN 20% SOLUTION / TOPICAL RLD, RS 1999-12-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020965-001 LEVULAN 20% SOLUTION / TOPICAL RLD, RS 1999-12-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020965-001 LEVULAN 20% SOLUTION / TOPICAL RLD, RS 1999-12-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020965-001 LEVULAN 20% SOLUTION / TOPICAL RLD, RS 1999-12-03 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 5 · 171 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N020965-001 11179574 2036-10-13 U-804 2025-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020965-001 11697028 2036-10-13 U-804 2025-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020965-001 12290700 2036-10-13 U-804 2025-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020965-001 11446512 2037-01-17 U-804 2025-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020965-001 10357567 2038-01-12 U-3163 2019-08-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020965-001 11077192 2038-01-12 U-3163 2021-08-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020965-001 11135293 2038-01-12 U-3163 2021-10-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020965-001 11571478 2038-01-12 U-3163 2023-06-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020965-001 11690914 2038-01-12 U-3163 2023-07-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020965-001 12296011 2038-01-12 U-3163 2025-06-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020965-001 11179574 2036-10-13 U-804 2025-05-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020965-001 11697028 2036-10-13 U-804 2025-05-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020965-001 12290700 2036-10-13 U-804 2025-05-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020965-001 11446512 2037-01-17 U-804 2025-05-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020965-001 10357567 2038-01-12 U-3163 2019-08-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020965-001 11077192 2038-01-12 U-3163 2021-08-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020965-001 11135293 2038-01-12 U-3163 2021-10-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020965-001 11571478 2038-01-12 U-3163 2023-06-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020965-001 11690914 2038-01-12 U-3163 2023-07-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020965-001 12296011 2038-01-12 U-3163 2025-06-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020965-001 11179574 2036-10-13 U-804 2025-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020965-001 11697028 2036-10-13 U-804 2025-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020965-001 12290700 2036-10-13 U-804 2025-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020965-001 11446512 2037-01-17 U-804 2025-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020965-001 10357567 2038-01-12 U-3163 2019-08-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020965-001 11077192 2038-01-12 U-3163 2021-08-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020965-001 11135293 2038-01-12 U-3163 2021-10-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020965-001 11571478 2038-01-12 U-3163 2023-06-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020965-001 11690914 2038-01-12 U-3163 2023-07-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020965-001 12296011 2038-01-12 U-3163 2025-06-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020965-001 10357567 2038-01-12 U-3163 2019-08-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020965-001 11077192 2038-01-12 U-3163 2021-08-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020965-001 11135293 2038-01-12 U-3163 2021-10-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020965-001 11571478 2038-01-12 U-3163 2023-06-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020965-001 11690914 2038-01-12 U-3163 2023-07-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020965-001 10357567 2038-01-12 U-3163 2019-08-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020965-001 11077192 2038-01-12 U-3163 2021-08-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020965-001 11135293 2038-01-12 U-3163 2021-10-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020965-001 11571478 2038-01-12 U-3163 2023-06-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020965-001 11690914 2038-01-12 U-3163 2023-07-14 b8a1b40f171c…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base LEVULAN KERASTICK
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 762672 Internal RxNorm lookup 762674 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67308-101-01 LEVULAN KERASTICK 1 in 1 APPLICATOR KIT 1 21 67308-101-02 LEVULAN KERASTICK 2 in 1 CARTON KIT 2 21 67308-101-06 LEVULAN KERASTICK 6 in 1 CARTON KIT 6 21
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67308-101 LEVULAN KERASTICK (AMINOLEVULINIC ACID HYDROCHLORIDE) KIT [SUN PHARMACEUTICAL INDUSTRIES, INC] 21 Current NDC, Legacy NDC, 3 package rows 20240913_e45cc371-9ebc-4904-12bc-65cb4e2817ad.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.
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 67308-101-01 67308010101 1 KIT in 1 APPLICATOR (67308-101-01) * 1.5 mL in 1 AMPULE * 1.5 mL in 1 AMPULE 1 kit 2000-09-04 0000-00-00 No No Current