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 TABLET
Routes
ORAL
Active Ingredients

delafloxacin meglumine 450 mg/1

Manufacturer
Melinta Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70842-101
Product ID 70842-101_fcc371f3-3214-4036-8834-33337e7cae0f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208610
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 70842101
Hyphenated Format 70842-101

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 NDA208610 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 450 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70842-101-01) / 20 TABLET in 1 BOTTLE
  • 2 BLISTER PACK in 1 CARTON (70842-101-02) / 10 TABLET in 1 BLISTER PACK (70842-101-03)
  • 1 BLISTER PACK in 1 CARTON (70842-101-05) / 2 TABLET in 1 BLISTER PACK
source: ndc

Packages (3)

70842-101-01 1 BOTTLE in 1 CARTON (70842-101-01) / 20 TABLET in 1 BOTTLE 70842-101-02 2 BLISTER PACK in 1 CARTON (70842-101-02) / 10 TABLET in 1 BLISTER PACK (70842-101-03) 70842-101-05 1 BLISTER PACK in 1 CARTON (70842-101-05) / 2 TABLET in 1 BLISTER PACK

Ingredients (1)

delafloxacin meglumine (450 mg/1)

Linked Drug Pages (1)

Baxdela ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "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": "1 BOTTLE in 1 CARTON (70842-101-01)  / 20 TABLET in 1 BOTTLE", "package_ndc": "70842-101-01", "marketing_start_date": "20170619"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (70842-101-02)  / 10 TABLET in 1 BLISTER PACK (70842-101-03)", "package_ndc": "70842-101-02", "marketing_start_date": "20170619"}, {"sample": true, "description": "1 BLISTER PACK in 1 CARTON (70842-101-05)  / 2 TABLET in 1 BLISTER PACK", "package_ndc": "70842-101-05", "marketing_start_date": "20180509"}], "brand_name": "Baxdela", "product_id": "70842-101_fcc371f3-3214-4036-8834-33337e7cae0f", "dosage_form": "TABLET", "pharm_class": ["Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "70842-101", "generic_name": "delafloxacin meglumine", "labeler_name": "Melinta Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Baxdela", "active_ingredients": [{"name": "DELAFLOXACIN MEGLUMINE", "strength": "450 mg/1"}], "application_number": "NDA208610", "marketing_category": "NDA", "marketing_start_date": "20170619", "listing_expiration_date": "20261231"}