FDA.reportPublic FDA data

NUZYRA

Product NDC
71715-002
11-digit product format
717150002
Labeler code
71715
Product ID
71715-002_2e800cb7-f314-ad1d-e063-6294a90a4685
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
omadacycline
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Paratek Pharmaceuticals, Inc.
Application
NDA209816
Marketing category
NDA
Marketing start
2019-02-01
Substance
OMADACYCLINE
Active strength
150 mg/1
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
OMADACYCLINE150 mg/1

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
71715-002-21NUZYRA1 in 1 CARTONTABLET, FILM COATED112
71715-002-23NUZYRA14 in 1 BLISTER PACKTABLET, FILM COATED1412
71715-002-24NUZYRA16 in 1 BLISTER PACKTABLET, FILM COATED1612
71715-002-27NUZYRA5 in 1 CARTONTABLET, FILM COATED512
71715-002-28NUZYRA6 in 1 BLISTER PACKTABLET, FILM COATED612

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71715-002-21EA - Each71715-002e974cf66-cc2e-4ca7-bf0e-1396890dfe7a12019-01-24
71715-002-23EA - Each71715-002f588810d-4599-4b38-b2ee-7a823aee016212019-01-24
71715-002-24EA - Each71715-00231f9150f-9af5-41fa-87e9-25598b78c53d12019-01-24
71715-002-27EA - Each71715-002f99a4ec1-1eb3-430b-b2d6-1b735eb27e1012020-03-10
71715-002-28EA - Each71715-002b331b988-f4b4-4445-a354-129a89253cf412021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71715-002NUZYRA (OMADACYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION NUZYRA (OMADACYCLINE) TABLET, FILM COATED [PARATEK PHARMACEUTICALS, INC.]11Current NDC, Legacy NDC, 5 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
71715-002-21717150002211 BLISTER PACK in 1 CARTON (71715-002-21) / 6 TABLET, FILM COATED in 1 BLISTER PACK (71715-002-28) 1 blister pack2020-02-010000-00-00NoNoCurrent
71715-002-237171500022314 in 1 BLISTER PACKHistorical
71715-002-247171500022416 in 1 BLISTER PACKHistorical
71715-002-27717150002275 BLISTER PACK in 1 CARTON (71715-002-27) / 6 TABLET, FILM COATED in 1 BLISTER PACK (71715-002-28) 5 blister pack2020-02-010000-00-00NoNoCurrent
71715-002-28717150002286 in 1 BLISTER PACKHistorical