baxdela

Generic: delafloxacin meglumine

Labeler: melinta therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name baxdela
Generic Name delafloxacin meglumine
Labeler melinta therapeutics, llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

delafloxacin meglumine 300 mg/10.5mL

Manufacturer
Melinta Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70842-102
Product ID 70842-102_fcc371f3-3214-4036-8834-33337e7cae0f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208611
Listing Expiration 2026-12-31
Marketing Start 2017-06-19

Pharmacologic Class

Classes
fluoroquinolone antibacterial [epc] fluoroquinolones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70842102
Hyphenated Format 70842-102

Supplemental Identifiers

RxCUI
1927667 1927672 1927677 1927682
UNII
N7V53U4U4T

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 baxdela (source: ndc)
Generic Name delafloxacin meglumine (source: ndc)
Application Number NDA208611 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 300 mg/10.5mL
source: ndc
Packaging
  • 10 VIAL, GLASS in 1 CARTON (70842-102-03) / 10.5 mL in 1 VIAL, GLASS (70842-102-01)
source: ndc

Packages (1)

70842-102-03 10 VIAL, GLASS in 1 CARTON (70842-102-03) / 10.5 mL in 1 VIAL, GLASS (70842-102-01)

Ingredients (1)

delafloxacin meglumine (300 mg/10.5mL)

Linked Drug Pages (1)

Baxdela ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "fcc371f3-3214-4036-8834-33337e7cae0f", "openfda": {"unii": ["N7V53U4U4T"], "rxcui": ["1927667", "1927672", "1927677", "1927682"], "spl_set_id": ["fb77637a-88d9-4aea-958f-e270030ce30d"], "manufacturer_name": ["Melinta Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, GLASS in 1 CARTON (70842-102-03)  / 10.5 mL in 1 VIAL, GLASS (70842-102-01)", "package_ndc": "70842-102-03", "marketing_start_date": "20170619"}], "brand_name": "Baxdela", "product_id": "70842-102_fcc371f3-3214-4036-8834-33337e7cae0f", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "70842-102", "generic_name": "delafloxacin meglumine", "labeler_name": "Melinta Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Baxdela", "active_ingredients": [{"name": "DELAFLOXACIN MEGLUMINE", "strength": "300 mg/10.5mL"}], "application_number": "NDA208611", "marketing_category": "NDA", "marketing_start_date": "20170619", "listing_expiration_date": "20261231"}