Home NDC 70842-140 Orbactiv
Product NDC 70842-140
11-digit product format 708420140
Labeler code 70842
Product ID 70842-140_cf310656-14c7-460e-a181-1aafed154999
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name oritavancin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Melinta Therapeutics, LLC
Application NDA206334
Marketing category NDA
Marketing start 2014-09-01
Substance ORITAVANCIN
Active strength 400 mg/1
Pharmacologic classes Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Lipoglycopeptide Antibacterial [EPC], Lipoglycopeptides [CS]
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 N206334-001 ORBACTIV ORITAVANCIN DIPHOSPHATE EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06
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 N206334-001 12514899 2029-08-29 U-4398 2026-02-03 N206334-001 8420592 2029-08-29 U-1570 2014-09-17 N206334-001 9682061 2030-04-26 U-1569 2017-07-20 N206334-001 9649352 2035-07-16 Drug product 2017-06-14
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 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N206334-001 ORBACTIV EQ 400MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-08-06 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 4 · 139 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 N206334-001 12514899 2029-08-29 U-4398 2026-02-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206334-001 8420592 2029-08-29 U-1570 2014-09-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206334-001 9682061 2030-04-26 U-1569 2017-07-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206334-001 9649352 2035-07-16 Drug product 2017-06-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 N206334-001 12514899 2029-08-29 U-4398 2026-02-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206334-001 8420592 2029-08-29 U-1570 2014-09-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206334-001 9682061 2030-04-26 U-1569 2017-07-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206334-001 9649352 2035-07-16 Drug product 2017-06-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N206334-001 12514899 2029-08-29 U-4398 2026-02-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206334-001 8420592 2029-08-29 U-1570 2014-09-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206334-001 9682061 2030-04-26 U-1569 2017-07-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206334-001 9649352 2035-07-16 Drug product 2017-06-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206334-001 8420592 2029-08-29 U-1570 2014-09-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206334-001 9682061 2030-04-26 U-1569 2017-07-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206334-001 9649352 2035-07-16 Drug product 2017-06-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206334-001 8420592 2029-08-29 U-1570 2014-09-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206334-001 9682061 2030-04-26 U-1569 2017-07-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206334-001 9649352 2035-07-16 Drug product 2017-06-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206334-001 8420592 2029-08-29 U-1570 2014-09-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206334-001 9682061 2030-04-26 U-1569 2017-07-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206334-001 9649352 2035-07-16 Drug product 2017-06-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206334-001 8420592 2029-08-29 U-1570 2014-09-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206334-001 9682061 2030-04-26 U-1569 2017-07-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206334-001 9649352 2035-07-16 Drug product 2017-06-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206334-001 8420592 2029-08-29 U-1570 2014-09-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206334-001 9682061 2030-04-26 U-1569 2017-07-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206334-001 9649352 2035-07-16 Drug product 2017-06-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206334-001 8420592 2029-08-29 U-1570 2014-09-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206334-001 9682061 2030-04-26 U-1569 2017-07-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206334-001 9649352 2035-07-16 Drug product 2017-06-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206334-001 8420592 2029-08-29 U-1570 2014-09-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206334-001 9682061 2030-04-26 U-1569 2017-07-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206334-001 9649352 2035-07-16 Drug product 2017-06-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206334-001 8420592 2029-08-29 U-1570 2014-09-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206334-001 9682061 2030-04-26 U-1569 2017-07-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206334-001 9649352 2035-07-16 Drug product 2017-06-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206334-001 8420592 2029-08-29 U-1570 2014-09-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N206334-001 9682061 2030-04-26 U-1569 2017-07-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N206334-001 9649352 2035-07-16 Drug product 2017-06-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206334-001 8420592 2029-08-29 U-1570 2014-09-17 79d66fd596c7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 70 observed states.
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 Orbactiv
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ORITAVANCIN 400 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70842-140-01 Orbactiv 1 in 1 VIAL, GLASS INJECTION, POWDER, LYOPHILIZED, 1 12 70842-140-03 Orbactiv 3 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 3 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70842-140 ORBACTIV (ORITAVANCIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MELINTA THERAPEUTICS, LLC] 11 Current NDC, Legacy NDC, 2 package rows 20241222_ff09a726-9f9b-4e30-b509-396781293220.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 70842-140-01 70842014001 1 in 1 VIAL, GLASS Historical 70842-140-03 70842014003 3 VIAL, GLASS in 1 CARTON (70842-140-03) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (70842-140-01) 2014-09-01 0000-00-00 No No Current