Home NDC 64011-701 Vyleesi
Product NDC 64011-701
11-digit product format 640110701
Labeler code 64011
Product ID 64011-701_ae24b6c4-e9c0-4108-89f2-3b2ba4166b49
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name bremelanotide
Dosage form INJECTION
Route SUBCUTANEOUS
Labeler AMAG Pharmaceuticals, Inc.
Application NDA210557
Marketing category NDA
Marketing start 2019-06-21
Marketing end 0000-00-00
Substance BREMELANOTIDE ACETATE
Active strength 2 mg/.3mL
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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 · 45 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 64011-701-04 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 64011-701-12 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 64011-701-04 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 64011-701-12 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 64011-701-04 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 64011-701-12 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 64011-701-04 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 64011-701-12 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 64011-701-04 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 64011-701-12 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 64011-701-04 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 64011-701-12 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 64011-701-04 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 64011-701-12 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 64011-701-04 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 64011-701-12 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 64011-701-04 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 64011-701-12 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 64011-701-04 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 64011-701-12 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 64011-701-04 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 64011-701-12 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 64011-701-04 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 64011-701-12 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 64011-701-04 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 64011-701-12 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 64011-701-04 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 64011-701-12 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 64011-701-04 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 64011-701-12 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…
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# FDA-Initiated Inactive NDC Indexing# 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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64011-701-04 64011070104 4 SYRINGE in 1 CARTON (64011-701-04) > .3 mL in 1 SYRINGE (64011-701-01) 4 syringe 2019-06-21 0000-00-00 No No Current 64011-701-12 64011070112 2 SYRINGE in 1 CARTON (64011-701-12) > .3 mL in 1 SYRINGE (64011-701-01) 2 syringe 2019-09-09 0000-00-00 No No Current