Home NDC 0713-0897 Vyleesi
Product NDC 0713-0897
11-digit product format 007130897
Labeler code 0713
Product ID 0713-0897_437e6c45-dfb9-35ec-e063-6394a90a7874
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name bremelanotide
Dosage form INJECTION
Route SUBCUTANEOUS
Labeler Cosette Pharmaceuticals, Inc.
Application NDA210557
Marketing category NDA
Marketing start 2025-11-12
Substance BREMELANOTIDE ACETATE
Active strength 1.75 mg/.3mL
Pharmacologic classes Melanocortin Receptor Agonist [EPC], Melanocortin Receptor Agonists [MoA]
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 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 · 43 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 N210557-001 VYLEESI (AUTOINJECTOR) EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-06-21 84e616aacf4f…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…
Observed Orange Book patent history# Patent history page 1 of 6 · 202 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 N210557-001 10286034 2033-11-05 U-2568 2019-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210557-001 9352013 2033-11-05 U-2568 2019-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210557-001 9700592 2033-11-05 U-2568 2019-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210557-001 11590209 2041-04-29 U-3539 2023-03-10 84e616aacf4f…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…
Observed Orange Book exclusivity history# 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 Vyleesi
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BREMELANOTIDE ACETATE 1.75 mg/.3mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination PV2WI7495P Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2176316 Internal RxNorm lookup 2176321 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 0713-0897-04 Vyleesi 4 in 1 CARTON INJECTION 4 1 0713-0897-06 Vyleesi 0.3 mL in 1 SYRINGE INJECTION 0.3 1
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 Sample Exclude flag Status 0713-0897-04 00713089704 4 SYRINGE in 1 CARTON (0713-0897-04) / .3 mL in 1 SYRINGE (0713-0897-06) 4 syringe 2025-11-12 No No Current 0713-0897-06 00713089706 0.3 mL in 1 SYRINGE 0.3 ml Historical