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NDC 70842-0101-01 Baxdela 450 mg/1 Details
Baxdela 450 mg/1
Baxdela is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Melinta Therapeutics, LLC. The primary component is DELAFLOXACIN MEGLUMINE.
MedlinePlus Drug Summary
Delafloxacin is used to treat skin infections and certain types of pneumonia (an infection of the lungs) caused by bacteria in adults. Delafloxacin is in a class of antibiotics called fluoroquinolones. It works by killing the bacteria that cause infections. Antibiotics such as delafloxacin will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
Related Packages: 70842-0101-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Delafloxacin
Product Information
| NDC | 70842-0101 |
|---|---|
| Product ID | 70842-101_3005a09f-04c1-42d2-85c9-3ed861e26c2e |
| Associated GPIs | 05000025100320 |
| GCN Sequence Number | 077492 |
| GCN Sequence Number Description | delafloxacin meglumine TABLET 450 MG ORAL |
| HIC3 | W1Q |
| HIC3 Description | QUINOLONE ANTIBIOTICS |
| GCN | 43532 |
| HICL Sequence Number | 044372 |
| HICL Sequence Number Description | DELAFLOXACIN MEGLUMINE |
| Brand/Generic | Brand |
| Proprietary Name | Baxdela |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | delafloxacin meglumine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 450 |
| Active Ingredient Units | mg/1 |
| Substance Name | DELAFLOXACIN MEGLUMINE |
| Labeler Name | Melinta Therapeutics, LLC |
| Pharmaceutical Class | Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA208610 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 70842-0101-01 (70842010101)
| NDC Package Code | 70842-101-01 |
|---|---|
| Billing NDC | 70842010101 |
| Package | 1 BOTTLE in 1 CARTON (70842-101-01) / 20 TABLET in 1 BOTTLE |
| Marketing Start Date | 2017-06-19 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |