FDA.reportPublic FDA data

NUZYRA

Product NDC
71715-001
11-digit product format
717150001
Labeler code
71715
Product ID
71715-001_2e800cb7-f314-ad1d-e063-6294a90a4685
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
omadacycline
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Paratek Pharmaceuticals, Inc.
Application
NDA209817
Marketing category
NDA
Marketing start
2019-02-01
Substance
OMADACYCLINE
Active strength
100 mg/5mL
Pharmacologic classes
Tetracycline-class Antibacterial [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMADACYCLINE100 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii090IP5RV8F
Rxcui2059274, 2059280, 2059288, 2059292

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3fa6aa83-a9e1-46b5-b173-313e856db8c2Product name120190108

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71715-001-01NUZYRA10 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,1012
71715-001-02NUZYRA10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,1012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71715-001-01EA - Each71715-001f0b11009-2a47-4ff1-a66e-5e84ef99e81712019-01-24
71715-001-02EA - Each71715-0011c83bce3-feba-4fbc-ad42-b4f80509b45b12019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71715-001NUZYRA (OMADACYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION NUZYRA (OMADACYCLINE) TABLET, FILM COATED [PARATEK PHARMACEUTICALS, INC.]11Current NDC, Legacy NDC, 2 package rows20250410_51591524-4703-44c6-8bde-dce3e6a463d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2059292NUZYRA 100 MG InjectionPSN51591524-4703-44c6-8bde-dce3e6a463d112
2059280NUZYRA 150 MG Oral TabletPSN51591524-4703-44c6-8bde-dce3e6a463d112
2059288omadacycline 100 MG InjectionPSN51591524-4703-44c6-8bde-dce3e6a463d112
2059274omadacycline 150 MG Oral TabletPSN51591524-4703-44c6-8bde-dce3e6a463d112
2059292omadacycline 100 MG Injection [Nuzyra]SBD51591524-4703-44c6-8bde-dce3e6a463d112
2059280omadacycline 150 MG Oral Tablet [Nuzyra]SBD51591524-4703-44c6-8bde-dce3e6a463d112
2059288omadacycline 100 MG InjectionSCD51591524-4703-44c6-8bde-dce3e6a463d112
2059274omadacycline 150 MG Oral TabletSCD51591524-4703-44c6-8bde-dce3e6a463d112
2059292Nuzyra 100 MG InjectionSY51591524-4703-44c6-8bde-dce3e6a463d112
2059280Nuzyra 150 MG Oral TabletSY51591524-4703-44c6-8bde-dce3e6a463d112
2059288omadacycline (as omadacycline tosylate) 100 MG InjectionSY51591524-4703-44c6-8bde-dce3e6a463d112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71715-001-017171500010110 mL in 1 VIAL, GLASS10 mlHistorical
71715-001-027171500010210 VIAL, GLASS in 1 CARTON (71715-001-02) / 10 mL in 1 VIAL, GLASS (71715-001-01) 2019-02-010000-00-00NoNoCurrent