NUZOLVENCE

Product NDC
68547-915
11-digit product format
685470915
Labeler code
68547
Product ID
68547-915_1835ee35-6c63-46c0-856f-6205e76af7b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zoliflodacin
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
La Jolla Pharmaceutical Company
Application
NDA219491
Marketing category
NDA
Marketing start
2026-04-01
Substance
ZOLIFLODACIN
Active strength
3 g/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
NUZOLVENCE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZOLIFLODACIN3 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFWL2263R77
Rxcui2739783, 2739789

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68547-915-10NUZOLVENCE1 in 1 CARTONFOR SUSPENSION13
68547-915-10NUZOLVENCE1 in 1 PACKETFOR SUSPENSION13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2739789NUZOLVENCE 3 GM Granules for Oral SuspensionPSN4beda35a-21b0-4b34-84ea-be6ea8cae50f3
2739783zoliflodacin 3 GM Granules for Oral SuspensionPSN4beda35a-21b0-4b34-84ea-be6ea8cae50f3
2739789zoliflodacin 3000 MG Granules for Oral Suspension [Nuzolvence]SBD4beda35a-21b0-4b34-84ea-be6ea8cae50f3
2739783zoliflodacin 3000 MG Granules for Oral SuspensionSCD4beda35a-21b0-4b34-84ea-be6ea8cae50f3
2739789Nuzolvence 3 GM Granules for Oral SuspensionSY4beda35a-21b0-4b34-84ea-be6ea8cae50f3
2739783zoliflodacin 3 GM Granules for Oral SuspensionSY4beda35a-21b0-4b34-84ea-be6ea8cae50f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68547-915-10685470915101 PACKET in 1 CARTON (68547-915-10) / 1 FOR SUSPENSION in 1 PACKET1 packet2026-04-01NoNoCurrent