NDC codes

FDA NDC Directory
Product NDC (as listed)70842-101Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70842-0101Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
70842-101-01708420101011 BOTTLE in 1 CARTON (70842-101-01) / 20 TABLET in 1 BOTTLEMarketed from Jun 19, 2017
70842-101-02708420101022 BLISTER PACK in 1 CARTON (70842-101-02) / 10 TABLET in 1 BLISTER PACK (70842-101-03)Marketed from Jun 19, 2017
70842-101-05708420101051 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 meglumine450 mg/1
Dosage form
Tablet
Route
Oral
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

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

N470842010101 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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