Home NDC 70842-240-01 REZZAYO
Product NDC 70842-240
Requested package NDC 70842-240-01
11-digit product format 708420240
Labeler code 70842
Product ID 70842-240_32d9ddc4-232f-45f9-ab7d-a34c46cf9b1c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name rezafungin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Melinta Therapeutics, LLC
Application NDA217417
Marketing category NDA
Marketing start 2023-06-09
Substance REZAFUNGIN
Active strength 200 mg/1
Pharmacologic classes Echinocandin Antifungal [EPC], Lipopeptides [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 N217417-001 REZZAYO REZAFUNGIN ACETATE EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22
Orange Book patents# Current patent rows page 1 of 1 · 7 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217417-001 11654196 2032-03-02 U-3566 Drug substance, Drug product 2023-06-14 N217417-001 10702573 2033-03-14 U-3566 Drug substance, Drug product 2023-04-20 N217417-001 9526835 2033-03-14 U-3566 Drug substance, Drug product 2023-04-20 N217417-001 8722619 2036-05-09 U-3566 Drug substance, Drug product 2023-04-20 N217417-001 11712459 2037-03-15 U-3566 Drug product 2023-08-30 N217417-001 11819533 2038-07-11 U-3566 Drug substance, Drug product 2023-12-20 N217417-001 11197909 2038-07-14 U-3566 Drug substance, Drug product 2023-04-20
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 4 matching rows.
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 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217417-001 REZZAYO EQ 200MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-03-22 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 4 · 160 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 N217417-001 11654196 2032-03-02 U-3566 Drug substance, Drug product 2023-06-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217417-001 10702573 2033-03-14 U-3566 Drug substance, Drug product 2023-04-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217417-001 9526835 2033-03-14 U-3566 Drug substance, Drug product 2023-04-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217417-001 8722619 2036-05-09 U-3566 Drug substance, Drug product 2023-04-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217417-001 11712459 2037-03-15 U-3566 Drug product 2023-08-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217417-001 11819533 2038-07-11 U-3566 Drug substance, Drug product 2023-12-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217417-001 11197909 2038-07-14 U-3566 Drug substance, Drug product 2023-04-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N217417-001 11654196 2032-03-02 U-3566 Drug substance, Drug product 2023-06-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217417-001 10702573 2033-03-14 U-3566 Drug substance, Drug product 2023-04-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217417-001 9526835 2033-03-14 U-3566 Drug substance, Drug product 2023-04-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217417-001 8722619 2036-05-09 U-3566 Drug substance, Drug product 2023-04-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217417-001 11712459 2037-03-15 U-3566 Drug product 2023-08-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217417-001 11819533 2038-07-11 U-3566 Drug substance, Drug product 2023-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217417-001 11197909 2038-07-14 U-3566 Drug substance, Drug product 2023-04-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217417-001 11654196 2032-03-02 U-3566 Drug substance, Drug product 2023-06-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217417-001 8722619 2032-03-02 U-3566 Drug substance, Drug product 2023-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217417-001 10702573 2033-03-14 U-3566 Drug substance, Drug product 2023-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217417-001 9526835 2033-03-14 U-3566 Drug substance, Drug product 2023-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217417-001 11712459 2037-03-15 U-3566 Drug product 2023-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217417-001 11819533 2038-07-11 U-3566 Drug substance, Drug product 2023-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217417-001 11197909 2038-07-14 U-3566 Drug substance, Drug product 2023-04-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217417-001 11654196 2032-03-02 U-3566 Drug substance, Drug product 2023-06-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217417-001 8722619 2032-03-02 U-3566 Drug substance, Drug product 2023-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217417-001 10702573 2033-03-14 U-3566 Drug substance, Drug product 2023-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217417-001 9526835 2033-03-14 U-3566 Drug substance, Drug product 2023-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217417-001 11712459 2037-03-15 U-3566 Drug product 2023-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217417-001 11819533 2038-07-11 U-3566 Drug substance, Drug product 2023-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217417-001 11197909 2038-07-14 U-3566 Drug substance, Drug product 2023-04-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217417-001 11654196 2032-03-02 U-3566 Drug substance, Drug product 2023-06-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217417-001 8722619 2032-03-02 U-3566 Drug substance, Drug product 2023-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217417-001 10702573 2033-03-14 U-3566 Drug substance, Drug product 2023-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217417-001 9526835 2033-03-14 U-3566 Drug substance, Drug product 2023-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217417-001 11712459 2037-03-15 U-3566 Drug product 2023-08-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217417-001 11819533 2038-07-11 U-3566 Drug substance, Drug product 2023-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217417-001 11197909 2038-07-14 U-3566 Drug substance, Drug product 2023-04-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217417-001 11654196 2032-03-02 U-3566 Drug substance, Drug product 2023-06-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217417-001 8722619 2032-03-02 U-3566 Drug substance, Drug product 2023-04-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217417-001 10702573 2033-03-14 U-3566 Drug substance, Drug product 2023-04-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217417-001 9526835 2033-03-14 U-3566 Drug substance, Drug product 2023-04-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217417-001 11712459 2037-03-15 U-3566 Drug product 2023-08-30 fd3edfee7708…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 96 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 REZZAYO
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength REZAFUNGIN 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G013B5478J Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2639160 Internal RxNorm lookup 2639165 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 70842-240-01 REZZAYO 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 4 70842-240-01 REZZAYO 1 in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70842-240 REZZAYO (REZAFUNGIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MELINTA THERAPEUTICS, LLC] 2 Current NDC, 2 package rows 20241024_90073508-6dca-4d27-aa5a-ed837737c35b.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 Sample Exclude flag Status 70842-240-01 70842024001 1 VIAL in 1 CARTON (70842-240-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL 1 vial 2023-06-09 No No Current