🇺🇸
United States · US · US:70842-102_fcc371f3-3214-4036-8834-33337e7cae0f
Baxdela
Orange BookUNIISPLATC J01MA23
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMelinta Therapeutics, LLC
CountryUS (United States)
ATC codeJ01MA23
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11708421020310 VIAL, GLASS in 1 CARTON (70842-102-03) / 10.5 mL in 1 VIAL, GLASS (70842-102-01)
Annotations
UNII (FDA Substance ID)
N7V53U4U4T
DELAFLOXACIN MEGLUMINE
RxCUI 1927662
Orange Book
N208611
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "N7V53U4U4T",
"rxcui": "1927662",
"inchikey": "AHJGUEMIZPMAMR-WZTVWXICSA-N",
"display_name": "DELAFLOXACIN MEGLUMINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"fb77637a-88d9-4aea-958f-e270030ce30d": {
"match": "brand_token",
"title": "BAXDELA (DELAFLOXACIN MEGLUMINE) TABLET BAXDELA (DELAFLOXACIN MEGLUMINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MELINTA THERAPEUTICS, LLC]",
"spl_version": "21",
"published_date": "2025-08-11"
}
},
"productid": "70842-102_fcc371f3-3214-4036-8834-33337e7cae0f",
"productndc": "70842-102",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "208611",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 300MG BASE/VIAL",
"product_no": "001",
"approval_date": "Jun 19, 2017"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DELAFLOXACIN MEGLUMINE",
"proprietary_name": "Baxdela",
"active_ingred_unit": "mg/10.5mL",
"application_number": "NDA208611",
"marketing_category": "NDA",
"nonproprietary_name": "delafloxacin meglumine",
"start_marketing_date": "20170619",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code J01MA23.
- 🇺🇸BaxdelaMelinta Therapeutics, LLC
- PLQuofenixA. Menarini - Industrie Farmaceutiche Riunite – s.r.l.
- DKQuofenixA. Menarini Industrie Farmaceutiche Riunite S.r.l.
- 🇨🇭QuofenixA. Menarini GmbH
- 🇨🇭QuofenixA. Menarini GmbH
- DKQuofenixA. Menarini Industrie Farmaceutiche Riunite S.r.l.
- PLQuofenixA. Menarini - Industrie Farmaceutiche Riunite – s.r.l.
- ISQuofenixA. Menarini Industrie Farmaceutiche Riunite Srl
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