Home NDC 80064-141 Vyleesi
Product NDC 80064-141
11-digit product format 800640141
Labeler code 80064
Product ID 80064-141_2b5b7036-1413-8c2f-e063-6394a90adf3b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name bremelanotide
Dosage form INJECTION
Route SUBCUTANEOUS
Labeler Palatin Technologies
Application NDA210557
Marketing category NDA
Marketing start 2019-06-21
Marketing end 2026-07-01
Substance BREMELANOTIDE ACETATE
Active strength 1.75 mg/.3mL
Pharmacologic classes Melanocortin Receptor Agonist [EPC], Melanocortin Receptor Agonists [MoA]
NDC exclude flag No
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 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 80064-141 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 80064-141 80064-141-04 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 80064-141 80064-141-02 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
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 N210557-001 VYLEESI (AUTOINJECTOR) BREMELANOTIDE ACETATE EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-06-21
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210557-001 10286034 2033-11-05 U-2568 2019-07-10 N210557-001 9352013 2033-11-05 U-2568 2019-07-10 N210557-001 9700592 2033-11-05 U-2568 2019-07-10 N210557-001 11590209 2041-04-29 U-3539 2023-03-10
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 N210557-001 VYLEESI (AUTOINJECTOR) EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-06-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210557-001 VYLEESI (AUTOINJECTOR) EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-06-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210557-001 VYLEESI (AUTOINJECTOR) EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-06-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210557-001 VYLEESI (AUTOINJECTOR) EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-06-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210557-001 VYLEESI (AUTOINJECTOR) EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-06-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210557-001 VYLEESI (AUTOINJECTOR) EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-06-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210557-001 VYLEESI (AUTOINJECTOR) EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-06-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210557-001 VYLEESI (AUTOINJECTOR) EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-06-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210557-001 VYLEESI (AUTOINJECTOR) EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-06-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210557-001 VYLEESI (AUTOINJECTOR) EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-06-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210557-001 VYLEESI (AUTOINJECTOR) EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-06-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210557-001 VYLEESI (AUTOINJECTOR) EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-06-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210557-001 VYLEESI (AUTOINJECTOR) EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-06-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210557-001 VYLEESI (AUTOINJECTOR) EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-06-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210557-001 VYLEESI (AUTOINJECTOR) EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-06-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210557-001 VYLEESI (AUTOINJECTOR) EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-06-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210557-001 VYLEESI (AUTOINJECTOR) EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-06-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210557-001 VYLEESI (AUTOINJECTOR) EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-06-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210557-001 VYLEESI (AUTOINJECTOR) EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-06-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210557-001 VYLEESI (AUTOINJECTOR) EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-06-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210557-001 VYLEESI (AUTOINJECTOR) EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-06-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N210557-001 VYLEESI (AUTOINJECTOR) EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-06-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N210557-001 VYLEESI (AUTOINJECTOR) EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-06-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N210557-001 VYLEESI (AUTOINJECTOR) EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-06-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N210557-001 VYLEESI (AUTOINJECTOR) EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-06-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N210557-001 VYLEESI (AUTOINJECTOR) EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-06-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N210557-001 VYLEESI (AUTOINJECTOR) EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-06-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N210557-001 VYLEESI (AUTOINJECTOR) EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-06-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N210557-001 VYLEESI (AUTOINJECTOR) EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-06-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N210557-001 VYLEESI (AUTOINJECTOR) EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-06-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N210557-001 VYLEESI (AUTOINJECTOR) EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-06-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N210557-001 VYLEESI (AUTOINJECTOR) EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-06-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N210557-001 VYLEESI (AUTOINJECTOR) EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-06-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N210557-001 VYLEESI (AUTOINJECTOR) EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-06-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N210557-001 VYLEESI (AUTOINJECTOR) EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-06-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N210557-001 VYLEESI (AUTOINJECTOR) EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-06-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N210557-001 VYLEESI (AUTOINJECTOR) EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-06-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N210557-001 VYLEESI (AUTOINJECTOR) EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-06-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N210557-001 VYLEESI (AUTOINJECTOR) EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-06-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N210557-001 VYLEESI (AUTOINJECTOR) EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-06-21 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 5 · 198 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N210557-001 10286034 2033-11-05 U-2568 2019-07-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210557-001 9352013 2033-11-05 U-2568 2019-07-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210557-001 9700592 2033-11-05 U-2568 2019-07-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210557-001 11590209 2041-04-29 U-3539 2023-03-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210557-001 10286034 2033-11-05 U-2568 2019-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210557-001 9352013 2033-11-05 U-2568 2019-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210557-001 9700592 2033-11-05 U-2568 2019-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210557-001 11590209 2041-04-29 U-3539 2023-03-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210557-001 6794489 2025-06-28 Drug substance, Drug product 2019-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210557-001 10286034 2033-11-05 U-2568 2019-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210557-001 9352013 2033-11-05 U-2568 2019-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210557-001 9700592 2033-11-05 U-2568 2019-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210557-001 11590209 2041-04-29 U-3539 2023-03-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210557-001 6794489 2025-06-28 Drug substance, Drug product 2019-07-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210557-001 10286034 2033-11-05 U-2568 2019-07-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210557-001 9352013 2033-11-05 U-2568 2019-07-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210557-001 9700592 2033-11-05 U-2568 2019-07-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210557-001 11590209 2041-04-29 U-3539 2023-03-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210557-001 6794489 2025-06-28 Drug substance, Drug product 2019-07-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210557-001 10286034 2033-11-05 U-2568 2019-07-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210557-001 9352013 2033-11-05 U-2568 2019-07-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210557-001 9700592 2033-11-05 U-2568 2019-07-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210557-001 11590209 2041-04-29 U-3539 2023-03-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210557-001 6794489 2025-06-28 Drug substance, Drug product 2019-07-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210557-001 10286034 2033-11-05 U-2568 2019-07-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210557-001 9352013 2033-11-05 U-2568 2019-07-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210557-001 9700592 2033-11-05 U-2568 2019-07-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210557-001 11590209 2041-04-29 U-3539 2023-03-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210557-001 6794489 2025-06-28 Drug substance, Drug product 2019-07-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210557-001 10286034 2033-11-05 U-2568 2019-07-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210557-001 9352013 2033-11-05 U-2568 2019-07-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210557-001 9700592 2033-11-05 U-2568 2019-07-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210557-001 11590209 2041-04-29 U-3539 2023-03-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210557-001 6794489 2025-06-28 Drug substance, Drug product 2019-07-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210557-001 10286034 2033-11-05 U-2568 2019-07-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210557-001 9352013 2033-11-05 U-2568 2019-07-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210557-001 9700592 2033-11-05 U-2568 2019-07-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210557-001 11590209 2041-04-29 U-3539 2023-03-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210557-001 6794489 2025-06-28 Drug substance, Drug product 2019-07-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210557-001 10286034 2033-11-05 U-2568 2019-07-10 5bbf6a4d5a75…
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 80064-141-01 Vyleesi 0.3 mL in 1 SYRINGE INJECTION 0.3 6 80064-141-02 Vyleesi 2 in 1 CARTON INJECTION 2 6 80064-141-04 Vyleesi 4 in 1 CARTON INJECTION 4 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80064-141 VYLEESI (BREMELANOTIDE) INJECTION [PALATIN TECHNOLOGIES] 6 Current NDC, Legacy NDC, 3 package rows 20250112_8c9607a2-5b57-4a59-b159-cf196deebdd9.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 Vyleesi BREMELANOTIDE Cosette Pharmaceuticals, Inc. f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf 2025-11-13 Warnings, Adverse reactions Exact identifier application applno (NDA): 210557 application number: NDA210557
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 80064-141-01 80064014101 0.3 mL in 1 SYRINGE 0.3 ml Historical 80064-141-02 80064014102 2 SYRINGE in 1 CARTON (80064-141-02) / .3 mL in 1 SYRINGE (80064-141-01) 2 syringe 2019-06-21 2026-07-01 No No Current 80064-141-04 80064014104 4 SYRINGE in 1 CARTON (80064-141-04) / .3 mL in 1 SYRINGE (80064-141-01) 4 syringe 2019-06-21 2026-07-01 No No Current