Home NDC 70842-225-01 Kimyrsa
Product NDC 70842-225
Requested package NDC 70842-225-01
11-digit product format 708420225
Labeler code 70842
Product ID 70842-225_25ae2ae5-afce-4475-bf3c-45323e93a952
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name oritavancin diphosphate
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Melinta Therapeutics, LLC
Application NDA214155
Marketing category NDA
Marketing start 2021-03-23
Substance ORITAVANCIN DIPHOSPHATE
Active strength 1200 mg/40mL
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 2026-12-31
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 N214155-001 KIMYRSA ORITAVANCIN DIPHOSPHATE EQ 1.2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-03-12
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 N214155-001 12514899 2029-08-29 U-4398 2026-02-03 N214155-001 8420592 2029-08-29 U-3101 2021-04-12 N214155-001 9682061 2030-04-26 U-3101 2021-04-12 N214155-001 9649352 2035-07-16 Drug substance, Drug product 2021-04-12
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.
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 N214155-001 KIMYRSA EQ 1.2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-03-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 N214155-001 KIMYRSA EQ 1.2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-03-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214155-001 KIMYRSA EQ 1.2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-03-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214155-001 KIMYRSA EQ 1.2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-03-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214155-001 KIMYRSA EQ 1.2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-03-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214155-001 KIMYRSA EQ 1.2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-03-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214155-001 KIMYRSA EQ 1.2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-03-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214155-001 KIMYRSA EQ 1.2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-03-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214155-001 KIMYRSA EQ 1.2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-03-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214155-001 KIMYRSA EQ 1.2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-03-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214155-001 KIMYRSA EQ 1.2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-03-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214155-001 KIMYRSA EQ 1.2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-03-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214155-001 KIMYRSA EQ 1.2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-03-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214155-001 KIMYRSA EQ 1.2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-03-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214155-001 KIMYRSA EQ 1.2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-03-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214155-001 KIMYRSA EQ 1.2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-03-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214155-001 KIMYRSA EQ 1.2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-03-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214155-001 KIMYRSA EQ 1.2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-03-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214155-001 KIMYRSA EQ 1.2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-03-12 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214155-001 KIMYRSA EQ 1.2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-03-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N214155-001 KIMYRSA EQ 1.2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-03-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N214155-001 KIMYRSA EQ 1.2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-03-12 87673890dc5c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214155-001 KIMYRSA EQ 1.2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-03-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214155-001 KIMYRSA EQ 1.2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-03-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214155-001 KIMYRSA EQ 1.2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-03-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214155-001 KIMYRSA EQ 1.2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-03-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214155-001 KIMYRSA EQ 1.2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-03-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214155-001 KIMYRSA EQ 1.2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-03-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214155-001 KIMYRSA EQ 1.2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-03-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214155-001 KIMYRSA EQ 1.2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-03-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214155-001 KIMYRSA EQ 1.2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-03-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214155-001 KIMYRSA EQ 1.2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-03-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214155-001 KIMYRSA EQ 1.2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-03-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N214155-001 KIMYRSA EQ 1.2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-03-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214155-001 KIMYRSA EQ 1.2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-03-12 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214155-001 KIMYRSA EQ 1.2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-03-12 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 109 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 N214155-001 12514899 2029-08-29 U-4398 2026-02-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214155-001 8420592 2029-08-29 U-3101 2021-04-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214155-001 9682061 2030-04-26 U-3101 2021-04-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214155-001 9649352 2035-07-16 Drug substance, Drug product 2021-04-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 N214155-001 12514899 2029-08-29 U-4398 2026-02-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214155-001 8420592 2029-08-29 U-3101 2021-04-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214155-001 9682061 2030-04-26 U-3101 2021-04-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214155-001 9649352 2035-07-16 Drug substance, Drug product 2021-04-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214155-001 12514899 2029-08-29 U-4398 2026-02-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214155-001 8420592 2029-08-29 U-3101 2021-04-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214155-001 9682061 2030-04-26 U-3101 2021-04-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214155-001 9649352 2035-07-16 Drug substance, Drug product 2021-04-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214155-001 8420592 2029-08-29 U-3101 2021-04-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214155-001 9682061 2030-04-26 U-3101 2021-04-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214155-001 9649352 2035-07-16 Drug substance, Drug product 2021-04-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214155-001 8420592 2029-08-29 U-3101 2021-04-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214155-001 9682061 2030-04-26 U-3101 2021-04-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214155-001 9649352 2035-07-16 Drug substance, Drug product 2021-04-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214155-001 8420592 2029-08-29 U-3101 2021-04-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214155-001 9682061 2030-04-26 U-3101 2021-04-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214155-001 9649352 2035-07-16 Drug substance, Drug product 2021-04-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214155-001 8420592 2029-08-29 U-3101 2021-04-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214155-001 9682061 2030-04-26 U-3101 2021-04-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214155-001 9649352 2035-07-16 Drug substance, Drug product 2021-04-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214155-001 8420592 2029-08-29 U-3101 2021-04-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214155-001 9682061 2030-04-26 U-3101 2021-04-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214155-001 9649352 2035-07-16 Drug substance, Drug product 2021-04-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214155-001 8420592 2029-08-29 U-3101 2021-04-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214155-001 9682061 2030-04-26 U-3101 2021-04-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214155-001 9649352 2035-07-16 Drug substance, Drug product 2021-04-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214155-001 8420592 2029-08-29 U-3101 2021-04-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214155-001 9682061 2030-04-26 U-3101 2021-04-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214155-001 9649352 2035-07-16 Drug substance, Drug product 2021-04-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214155-001 8420592 2029-08-29 U-3101 2021-04-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214155-001 9682061 2030-04-26 U-3101 2021-04-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214155-001 9649352 2035-07-16 Drug substance, Drug product 2021-04-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214155-001 8420592 2029-08-29 U-3101 2021-04-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N214155-001 9682061 2030-04-26 U-3101 2021-04-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N214155-001 9649352 2035-07-16 Drug substance, Drug product 2021-04-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214155-001 8420592 2029-08-29 U-3101 2021-04-12 79d66fd596c7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 81 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 Kimyrsa
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ORITAVANCIN DIPHOSPHATE 1200 mg/40mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination VL1P93MKZN Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2532361 Internal RxNorm lookup 2532366 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 70842-225-01 Kimyrsa 40 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 40 7 70842-225-01 Kimyrsa 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70842-225 KIMYRSA (ORITAVANCIN DIPHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MELINTA THERAPEUTICS, LLC] 6 Current NDC, Legacy NDC, 2 package rows 20250508_5e755c40-6e73-4572-b474-4d8a131693d1.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 70842-225-01 70842022501 1 VIAL in 1 CARTON (70842-225-01) / 40 mL in 1 VIAL 1 vial 2021-03-23 0000-00-00 No No Current