Prescription drug · NDA
Baxdela (delafloxacin meglumine) NDC 70842-102
Delafloxacin meglumine 300 mg/10.5mL · Injection, Powder, Lyophilized, For solution · Intravenous · Melinta Therapeutics, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70842-102-03 | 70842010203 | 10 VIAL, GLASS in 1 CARTON (70842-102-03) / 10.5 mL in 1 VIAL, GLASS (70842-102-01)Marketed from Jun 19, 2017 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Baxdela
- Generic name (nonproprietary)
- delafloxacin meglumine
- Active ingredients
- Delafloxacin meglumine — 300 mg/10.5mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Melinta Therapeutics, LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208611
- Marketing start
- Listing expires
- Other FDA classes
- Fluoroquinolones (Chemical structure)
- Identifiers
- Product ID 70842-102_fcc371f3-3214-4036-8834-33337e7cae0fSPL ID fcc371f3-3214-4036-8834-33337e7cae0fSPL set ID fb77637a-88d9-4aea-958f-e270030ce30dRxCUI 1927667, 1927672, 1927677, 1927682UNII N7V53U4U4T
- Pharmacologic class
- Fluoroquinolone Antibacterial
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N470842010203followed by a unit qualifier and the quantityPackage 70842-0102-03. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
BAXDELA is a fluoroquinolone antibacterial indicated for the treatment of adults with the following infections caused by designated susceptible bacteria: Acute Bacterial Skin and Skin Structure Infections (ABSSSI) ( 1.1 ) Community-Acquired Bacterial Pneumonia (CABP) ( 1.2 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of BAXDELA and other antibacterial drugs, BAXDELA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.3 ) 1.1 Acute Bacterial Skin and Skin Structure Infections BAXDELA is indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) …
Excerpt only. Read the full label for complete information.