Home NDC 70842-120 VABOMERE
Product NDC 70842-120
11-digit product format 708420120
Labeler code 70842
Product ID 70842-120_163f9a07-823d-4c53-9136-8783e95f9cdc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Meropenem-Vaborbactam
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Melinta Therapeutics, LLC
Application NDA209776
Marketing category NDA
Marketing start 2017-10-02
Substance MEROPENEM; VABORBACTAM
Active strength 1; 1 g/2g; g/2g
Pharmacologic classes Carbapenems [CS], Penem Antibacterial [EPC], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [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 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.
Additional Listing Data#
Finished product Yes
Brand name base VABOMERE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VABORBACTAM 1 g/2g MEROPENEM 1 g/2g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1C75676F8V Internal UNII lookup FV9J3JU8B1 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1945218 Internal RxNorm lookup 1946651 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 70842-120-01 VABOMERE 2 g in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, FOR SOLUTION 2 14 70842-120-06 VABOMERE 6 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 6 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70842-120 VABOMERE (MEROPENEM-VABORBACTAM) INJECTION, POWDER, FOR SOLUTION [MELINTA THERAPEUTICS, LLC] 13 Current NDC, Legacy NDC, 2 package rows 20250417_e237fd0f-3050-42a3-b43e-b6fb4824e93d.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 Units Marketing start Marketing end Sample Exclude flag Status 70842-120-01 70842012001 2 g in 1 VIAL, SINGLE-DOSE 2 g Historical 70842-120-06 70842012006 6 VIAL, SINGLE-DOSE in 1 CARTON (70842-120-06) / 2 g in 1 VIAL, SINGLE-DOSE (70842-120-01) 2017-10-02 0000-00-00 No No Current