Prescription drug · NDA
Baxdela (Delafloxacin meglumine) NDC 70842-101
Delafloxacin meglumine 450 mg/1 · Tablet · Oral · Melinta Therapeutics, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70842-101-01 | 7084201010170842010101 | 1 BOTTLE in 1 CARTON (70842-101-01) / 20 TABLET in 1 BOTTLEMarketed from Jun 19, 2017 | |
| 70842-101-02 | 7084201010270842010102 | 2 BLISTER PACK in 1 CARTON (70842-101-02) / 10 TABLET in 1 BLISTER PACK (70842-101-03)Marketed from Jun 19, 2017 | |
| 70842-101-05 | 7084201010570842010105 | 1 BLISTER PACK in 1 CARTON (70842-101-05) / 2 TABLET in 1 BLISTER PACKMarketed from May 9, 2018 · Sample package |
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 — 450 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Melinta Therapeutics, LLCNDC labeler code 70842
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208610
- Marketing start
- Listing expires
- Other FDA classes
- Fluoroquinolones (Chemical structure)
- Identifiers
- Product ID 70842-101_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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N470842010101followed by a unit qualifier and the quantityPackage 70842-0101-01. 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.
About NDC 70842-101
- What is NDC 70842-101?
- 70842-101 is the product NDC for Baxdela (delafloxacin meglumine), Delafloxacin meglumine 450 mg/1 tablet, listed with the FDA by Melinta Therapeutics, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Baxdela (Delafloxacin meglumine).
- What is the active ingredient?
- Delafloxacin meglumine.
- Who is the labeler?
- Melinta Therapeutics, LLC, NDC labeler code 70842. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Baxdela?
- 1 other product NDC are listed under this name. See all Baxdela NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Baxdela products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Baxdeladelafloxacin meglumine | Delafloxacin meglumine 300 mg/10.5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Melinta Therapeutics, LLC | 70842-102 | 70842-0102-03 |