Home NDC 65293-009 VABOMERE
Product NDC 65293-009
11-digit product format 652930009
Labeler code 65293
Product ID 65293-009_580db23f-c656-3049-e053-2a91aa0ad616
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Meropenem-Vaborbactam
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler The Medicines Company
Application NDA209776
Marketing category NDA
Marketing start 2017-10-02
Marketing end 0000-00-00
Substance VABORBACTAM; MEROPENEM
Active strength 1 g/2g; g/2g
Pharmacologic classes beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Carbapenems [CS],Penem Antibacterial [EPC]
NDC exclude flag E
Listing certified through 2018-12-31
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 · 26 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 65293-009-06 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 65293-009-06 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 65293-009-06 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 65293-009-06 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 65293-009-06 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 65293-009-06 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 65293-009-06 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 65293-009-06 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 65293-009-06 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 65293-009-06 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 65293-009-06 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 65293-009-06 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 65293-009-06 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 N209776-001 VABOMERE MEROPENEM; VABORBACTAM 1GM/VIAL;1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2017-08-29
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 N209776-001 10172874 2031-08-08 Drug product 2019-02-21 N209776-001 10183034 2031-08-08 U-2490 2019-02-21 N209776-001 10561675 2031-08-08 U-2490 2020-03-18 N209776-001 11007206 2031-08-08 U-3128 2021-06-16 N209776-001 12171772 2031-08-08 Drug substance 2025-01-03 N209776-001 9694025 2031-08-08 U-2120 2017-09-27 N209776-001 8680136 2031-08-29 Drug substance, Drug product 2017-09-27 N209776-001 12478606 2038-01-08 U-3421 2025-12-08 N209776-001 11376237 2039-04-06 U-3421 2022-09-21 N209776-001 12533342 2039-04-06 U-3421 2026-01-29
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N209776-001 NCE 2022-08-29 N209776-001 GAIN 2027-08-29
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 N209776-001 VABOMERE 1GM/VIAL;1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2017-08-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209776-001 VABOMERE 1GM/VIAL;1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2017-08-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209776-001 VABOMERE 1GM/VIAL;1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2017-08-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209776-001 VABOMERE 1GM/VIAL;1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2017-08-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209776-001 VABOMERE 1GM/VIAL;1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2017-08-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209776-001 VABOMERE 1GM/VIAL;1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2017-08-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209776-001 VABOMERE 1GM/VIAL;1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2017-08-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209776-001 VABOMERE 1GM/VIAL;1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2017-08-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209776-001 VABOMERE 1GM/VIAL;1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2017-08-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209776-001 VABOMERE 1GM/VIAL;1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2017-08-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209776-001 VABOMERE 1GM/VIAL;1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2017-08-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209776-001 VABOMERE 1GM/VIAL;1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2017-08-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209776-001 VABOMERE 1GM/VIAL;1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2017-08-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209776-001 VABOMERE 1GM/VIAL;1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2017-08-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209776-001 VABOMERE 1GM/VIAL;1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2017-08-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209776-001 VABOMERE 1GM/VIAL;1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2017-08-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209776-001 VABOMERE 1GM/VIAL;1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2017-08-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209776-001 VABOMERE 1GM/VIAL;1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2017-08-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209776-001 VABOMERE 1GM/VIAL;1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2017-08-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N209776-001 VABOMERE 1GM/VIAL;1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2017-08-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209776-001 VABOMERE 1GM/VIAL;1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2017-08-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209776-001 VABOMERE 1GM/VIAL;1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2017-08-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209776-001 VABOMERE 1GM/VIAL;1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2017-08-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209776-001 VABOMERE 1GM/VIAL;1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2017-08-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209776-001 VABOMERE 1GM/VIAL;1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2017-08-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N209776-001 VABOMERE 1GM/VIAL;1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2017-08-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N209776-001 VABOMERE 1GM/VIAL;1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2017-08-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N209776-001 VABOMERE 1GM/VIAL;1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2017-08-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N209776-001 VABOMERE 1GM/VIAL;1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2017-08-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N209776-001 VABOMERE 1GM/VIAL;1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2017-08-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N209776-001 VABOMERE 1GM/VIAL;1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2017-08-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N209776-001 VABOMERE 1GM/VIAL;1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2017-08-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N209776-001 VABOMERE 1GM/VIAL;1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2017-08-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N209776-001 VABOMERE 1GM/VIAL;1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2017-08-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N209776-001 VABOMERE 1GM/VIAL;1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2017-08-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N209776-001 VABOMERE 1GM/VIAL;1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2017-08-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N209776-001 VABOMERE 1GM/VIAL;1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2017-08-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N209776-001 VABOMERE 1GM/VIAL;1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2017-08-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N209776-001 VABOMERE 1GM/VIAL;1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2017-08-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N209776-001 VABOMERE 1GM/VIAL;1GM/VIAL POWDER / INTRAVENOUS RLD, RS 2017-08-29 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 8 · 282 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 N209776-001 10172874 2031-08-08 Drug product 2019-02-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209776-001 10183034 2031-08-08 U-2490 2019-02-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209776-001 10561675 2031-08-08 U-2490 2020-03-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209776-001 11007206 2031-08-08 U-3128 2021-06-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209776-001 12171772 2031-08-08 Drug substance 2025-01-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209776-001 9694025 2031-08-08 U-2120 2017-09-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209776-001 8680136 2031-08-29 Drug substance, Drug product 2017-09-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209776-001 12478606 2038-01-08 U-3421 2025-12-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209776-001 11376237 2039-04-06 U-3421 2022-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209776-001 12533342 2039-04-06 U-3421 2026-01-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209776-001 10172874 2031-08-08 Drug product 2019-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209776-001 10183034 2031-08-08 U-2490 2019-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209776-001 10561675 2031-08-08 U-2490 2020-03-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209776-001 11007206 2031-08-08 U-3128 2021-06-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209776-001 12171772 2031-08-08 Drug substance 2025-01-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209776-001 9694025 2031-08-08 U-2120 2017-09-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209776-001 8680136 2031-08-29 Drug substance, Drug product 2017-09-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209776-001 12478606 2038-01-08 U-3421 2025-12-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209776-001 11376237 2039-04-06 U-3421 2022-09-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209776-001 12533342 2039-05-20 U-3421 2026-01-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209776-001 10172874 2031-08-08 Drug product 2019-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209776-001 10183034 2031-08-08 U-2490 2019-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209776-001 10561675 2031-08-08 U-2490 2020-03-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209776-001 11007206 2031-08-08 U-3128 2021-06-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209776-001 12171772 2031-08-08 Drug substance 2025-01-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209776-001 9694025 2031-08-08 U-2120 2017-09-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209776-001 8680136 2031-08-29 Drug substance, Drug product 2017-09-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209776-001 12478606 2038-01-08 U-3421 2025-12-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209776-001 11376237 2039-04-06 U-3421 2022-09-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209776-001 10172874 2031-08-08 Drug product 2019-02-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209776-001 10183034 2031-08-08 U-2490 2019-02-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209776-001 10561675 2031-08-08 U-2490 2020-03-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209776-001 11007206 2031-08-08 U-3128 2021-06-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209776-001 12171772 2031-08-08 Drug substance 2025-01-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209776-001 9694025 2031-08-08 U-2120 2017-09-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209776-001 8680136 2031-08-29 Drug substance, Drug product 2017-09-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209776-001 11376237 2039-04-06 U-3421 2022-09-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209776-001 10172874 2031-08-08 Drug product 2019-02-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209776-001 10183034 2031-08-08 U-2490 2019-02-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209776-001 10561675 2031-08-08 U-2490 2020-03-18 fd3edfee7708…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 68 observed states.
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 VABOMERE MEROPENEM-VABORBACTAM Melinta Therapeutics, LLC e237fd0f-3050-42a3-b43e-b6fb4824e93d 2026-02-27 Warnings, Adverse reactions Exact identifier application applno (NDA): 209776 application number: NDA209776