FDA.reportPublic FDA data

REZZAYO

Product NDC
70842-240
11-digit product format
708420240
Labeler code
70842
Product ID
70842-240_2b7bcdc0-0333-42a1-942c-7b2efeb2398a
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

Additional Listing Data#

Finished product
Yes
Brand name base
REZZAYO
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
REZAFUNGIN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG013B5478J
Rxcui2639160, 2639165

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
659eb057-9e5d-44b6-9d40-176bf0a584feProduct name120231005
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70842-240-01REZZAYO1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,14
70842-240-01REZZAYO1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70842-240-01EA - Each70842-2404e2e8bf3-8287-454d-9148-c58e87b595e012023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70842-240REZZAYO (REZAFUNGIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MELINTA THERAPEUTICS, LLC]2Current NDC, 2 package rows20241024_90073508-6dca-4d27-aa5a-ed837737c35b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2639160rezafungin 200 MG InjectionPSN90073508-6dca-4d27-aa5a-ed837737c35b4
2639165REZZAYO 200 MG InjectionPSN90073508-6dca-4d27-aa5a-ed837737c35b4
2639165rezafungin 200 MG Injection [Rezzayo]SBD90073508-6dca-4d27-aa5a-ed837737c35b4
2639160rezafungin 200 MG InjectionSCD90073508-6dca-4d27-aa5a-ed837737c35b4
2639160rezafungin 200 MG (as rezafungin acetate 210 MG) InjectionSY90073508-6dca-4d27-aa5a-ed837737c35b4
2639165Rezzayo (as rezafungin acetate) 200 MG InjectionSY90073508-6dca-4d27-aa5a-ed837737c35b4
2639165Rezzayo 200 MG InjectionSY90073508-6dca-4d27-aa5a-ed837737c35b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70842-240-01708420240011 VIAL in 1 CARTON (70842-240-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL1 vial2023-06-09NoNoCurrent