Home NDC 73372-0116 SCENESSE
Product NDC 73372-0116
11-digit product format 733720116
Labeler code 73372
Product ID 73372-0116_5192f26d-d5e7-ce03-e063-6294a90a3ea2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name afamelanotide
Dosage form IMPLANT
Route SUBCUTANEOUS
Labeler CLINUVEL INC.
Application NDA210797
Marketing category NDA
Marketing start 2019-12-31
Substance AFAMELANOTIDE
Active strength 16 mg/16mg
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 N210797-001 SCENESSE AFAMELANOTIDE 16MG IMPLANT / SUBCUTANEOUS RLD, RS 2019-10-08
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210797-001 8334265 2033-01-20 U-2638 2019-11-06
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N210797-001 ODE-270 2026-10-08
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 2026-09-14 22:38:34 2026-08 N210797-001 SCENESSE 16MG IMPLANT / SUBCUTANEOUS RLD, RS 2019-10-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 N210797-001 SCENESSE 16MG IMPLANT / SUBCUTANEOUS RLD, RS 2019-10-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210797-001 SCENESSE 16MG IMPLANT / SUBCUTANEOUS RLD, RS 2019-10-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210797-001 SCENESSE 16MG IMPLANT / SUBCUTANEOUS RLD, RS 2019-10-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210797-001 SCENESSE 16MG IMPLANT / SUBCUTANEOUS RLD, RS 2019-10-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210797-001 SCENESSE 16MG IMPLANT / SUBCUTANEOUS RLD, RS 2019-10-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210797-001 SCENESSE 16MG IMPLANT / SUBCUTANEOUS RLD, RS 2019-10-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210797-001 SCENESSE 16MG IMPLANT / SUBCUTANEOUS RLD, RS 2019-10-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210797-001 SCENESSE 16MG IMPLANT / SUBCUTANEOUS RLD, RS 2019-10-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210797-001 SCENESSE 16MG IMPLANT / SUBCUTANEOUS RLD, RS 2019-10-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210797-001 SCENESSE 16MG IMPLANT / SUBCUTANEOUS RLD, RS 2019-10-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210797-001 SCENESSE 16MG IMPLANT / SUBCUTANEOUS RLD, RS 2019-10-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210797-001 SCENESSE 16MG IMPLANT / SUBCUTANEOUS RLD, RS 2019-10-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210797-001 SCENESSE 16MG IMPLANT / SUBCUTANEOUS RLD, RS 2019-10-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210797-001 SCENESSE 16MG IMPLANT / SUBCUTANEOUS RLD, RS 2019-10-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210797-001 SCENESSE 16MG IMPLANT / SUBCUTANEOUS RLD, RS 2019-10-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210797-001 SCENESSE 16MG IMPLANT / SUBCUTANEOUS RLD, RS 2019-10-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210797-001 SCENESSE 16MG IMPLANT / SUBCUTANEOUS RLD, RS 2019-10-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210797-001 SCENESSE 16MG IMPLANT / SUBCUTANEOUS RLD, RS 2019-10-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210797-001 SCENESSE 16MG IMPLANT / SUBCUTANEOUS RLD, RS 2019-10-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210797-001 SCENESSE 16MG IMPLANT / SUBCUTANEOUS RLD, RS 2019-10-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210797-001 SCENESSE 16MG IMPLANT / SUBCUTANEOUS RLD, RS 2019-10-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N210797-001 SCENESSE 16MG IMPLANT / SUBCUTANEOUS RLD, RS 2019-10-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N210797-001 SCENESSE 16MG IMPLANT / SUBCUTANEOUS RLD, RS 2019-10-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N210797-001 SCENESSE 16MG IMPLANT / SUBCUTANEOUS RLD, RS 2019-10-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N210797-001 SCENESSE 16MG IMPLANT / SUBCUTANEOUS RLD, RS 2019-10-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N210797-001 SCENESSE 16MG IMPLANT / SUBCUTANEOUS RLD, RS 2019-10-08 3f01610625f2…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N210797-001 SCENESSE 16MG IMPLANT / SUBCUTANEOUS RLD, RS 2019-10-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N210797-001 SCENESSE 16MG IMPLANT / SUBCUTANEOUS RLD, RS 2019-10-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N210797-001 SCENESSE 16MG IMPLANT / SUBCUTANEOUS RLD, RS 2019-10-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N210797-001 SCENESSE 16MG IMPLANT / SUBCUTANEOUS RLD, RS 2019-10-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N210797-001 SCENESSE 16MG IMPLANT / SUBCUTANEOUS RLD, RS 2019-10-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N210797-001 SCENESSE 16MG IMPLANT / SUBCUTANEOUS RLD, RS 2019-10-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N210797-001 SCENESSE 16MG IMPLANT / SUBCUTANEOUS RLD, RS 2019-10-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N210797-001 SCENESSE 16MG IMPLANT / SUBCUTANEOUS RLD, RS 2019-10-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N210797-001 SCENESSE 16MG IMPLANT / SUBCUTANEOUS RLD, RS 2019-10-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N210797-001 SCENESSE 16MG IMPLANT / SUBCUTANEOUS RLD, RS 2019-10-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N210797-001 SCENESSE 16MG IMPLANT / SUBCUTANEOUS RLD, RS 2019-10-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N210797-001 SCENESSE 16MG IMPLANT / SUBCUTANEOUS RLD, RS 2019-10-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N210797-001 SCENESSE 16MG IMPLANT / SUBCUTANEOUS RLD, RS 2019-10-08 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 2 · 76 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 N210797-001 8334265 2033-01-20 U-2638 2019-11-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 N210797-001 8334265 2033-01-20 U-2638 2019-11-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210797-001 8334265 2033-01-20 U-2638 2019-11-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210797-001 10076555 2025-02-11 U-2638 2019-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210797-001 8334265 2033-01-20 U-2638 2019-11-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210797-001 10076555 2025-02-11 U-2638 2019-11-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210797-001 8334265 2033-01-20 U-2638 2019-11-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210797-001 10076555 2025-02-11 U-2638 2019-11-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210797-001 8334265 2029-03-11 U-2638 2019-11-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210797-001 10076555 2025-02-11 U-2638 2019-11-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210797-001 8334265 2029-03-11 U-2638 2019-11-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210797-001 10076555 2025-02-11 U-2638 2019-11-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210797-001 8334265 2029-03-11 U-2638 2019-11-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210797-001 10076555 2025-02-11 U-2638 2019-11-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210797-001 8334265 2029-03-11 U-2638 2019-11-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210797-001 10076555 2025-02-11 U-2638 2019-11-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210797-001 8334265 2029-03-11 U-2638 2019-11-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210797-001 10076555 2025-02-11 U-2638 2019-11-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210797-001 8334265 2029-03-11 U-2638 2019-11-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210797-001 10076555 2025-02-11 U-2638 2019-11-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210797-001 8334265 2029-03-11 U-2638 2019-11-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210797-001 10076555 2025-02-11 U-2638 2019-11-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210797-001 8334265 2029-03-11 U-2638 2019-11-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210797-001 10076555 2025-02-11 U-2638 2019-11-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210797-001 8334265 2029-03-11 U-2638 2019-11-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210797-001 10076555 2025-02-11 U-2638 2019-11-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210797-001 8334265 2029-03-11 U-2638 2019-11-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210797-001 10076555 2025-02-11 U-2638 2019-11-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N210797-001 8334265 2029-03-11 U-2638 2019-11-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210797-001 10076555 2025-02-11 U-2638 2019-11-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210797-001 8334265 2029-03-11 U-2638 2019-11-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210797-001 10076555 2025-02-11 U-2638 2019-11-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N210797-001 8334265 2029-03-11 U-2638 2019-11-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210797-001 10076555 2025-02-11 U-2638 2019-11-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N210797-001 8334265 2029-03-11 U-2638 2019-11-06 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N210797-001 10076555 2025-02-11 U-2638 2019-11-06 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N210797-001 8334265 2029-03-11 U-2638 2019-11-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210797-001 10076555 2025-02-11 U-2638 2019-11-06 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N210797-001 8334265 2029-03-11 U-2638 2019-11-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N210797-001 10076555 2025-02-11 U-2638 2019-11-06 87673890dc5c…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 73 observed states.
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 SCENESSE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AFAMELANOTIDE 16 mg/16mg
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination QW68W3J66U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2262254 Internal RxNorm lookup 2262259 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 73372-0116-1 SCENESSE 1 mg in 1 VIAL, GLASS IMPLANT 1 11 73372-0116-1 SCENESSE 1 in 1 CARTON IMPLANT 1 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 73372-0116 SCENESSE (AFAMELANOTIDE) IMPLANT [CLINUVEL INC.] 8 Current NDC, Legacy NDC, 2 package rows 20240816_94f53286-11dd-7fbb-e053-2a95a90a7c48.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 Marketing start Marketing end Sample Exclude flag Status 73372-0116-1 73372011601 1 VIAL, GLASS in 1 CARTON (73372-0116-1) / 1 mg in 1 VIAL, GLASS 2019-12-31 0000-00-00 No No Current