nuzyra

Generic: omadacycline

Labeler: paratek pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name nuzyra
Generic Name omadacycline
Labeler paratek pharmaceuticals, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

omadacycline 100 mg/5mL

Manufacturer
Paratek Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 71715-001
Product ID 71715-001_2e800cb7-f314-ad1d-e063-6294a90a4685
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209817
Listing Expiration 2026-12-31
Marketing Start 2019-02-01

Pharmacologic Class

Established (EPC)
tetracycline-class antibacterial [epc]
Chemical Structure
tetracyclines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71715001
Hyphenated Format 71715-001

Supplemental Identifiers

RxCUI
2059274 2059280 2059288 2059292
UPC
0371715002277 0371715001027 0371715002215
UNII
090IP5RV8F
NUI
N0000175938 M0021223

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name nuzyra (source: ndc)
Generic Name omadacycline (source: ndc)
Application Number NDA209817 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 10 VIAL, GLASS in 1 CARTON (71715-001-02) / 10 mL in 1 VIAL, GLASS (71715-001-01)
source: ndc

Packages (1)

71715-001-02 10 VIAL, GLASS in 1 CARTON (71715-001-02) / 10 mL in 1 VIAL, GLASS (71715-001-01)

Ingredients (1)

omadacycline (100 mg/5mL)

Linked Drug Pages (1)

NUZYRA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "2e800cb7-f314-ad1d-e063-6294a90a4685", "openfda": {"nui": ["N0000175938", "M0021223"], "upc": ["0371715002277", "0371715001027", "0371715002215"], "unii": ["090IP5RV8F"], "rxcui": ["2059274", "2059280", "2059288", "2059292"], "spl_set_id": ["51591524-4703-44c6-8bde-dce3e6a463d1"], "pharm_class_cs": ["Tetracyclines [CS]"], "pharm_class_epc": ["Tetracycline-class Antibacterial [EPC]"], "manufacturer_name": ["Paratek Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, GLASS in 1 CARTON (71715-001-02)  / 10 mL in 1 VIAL, GLASS (71715-001-01)", "package_ndc": "71715-001-02", "marketing_start_date": "20190201"}], "brand_name": "NUZYRA", "product_id": "71715-001_2e800cb7-f314-ad1d-e063-6294a90a4685", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Tetracycline-class Antibacterial [EPC]", "Tetracyclines [CS]"], "product_ndc": "71715-001", "generic_name": "omadacycline", "labeler_name": "Paratek Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NUZYRA", "active_ingredients": [{"name": "OMADACYCLINE", "strength": "100 mg/5mL"}], "application_number": "NDA209817", "marketing_category": "NDA", "marketing_start_date": "20190201", "listing_expiration_date": "20261231"}