NDC codes

FDA NDC Directory
Product NDC (as listed)68001-376Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68001-0376Add 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
68001-376-68680010376681 VIAL, SINGLE-DOSE in 1 CARTON (68001-376-68) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from May 1, 2019

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)
Daptomycin
Generic name (nonproprietary)
daptomycin
Active ingredients
Daptomycin — 500 mg/10mL
Dosage form
Injection, Powder, Lyophilized, For solution
Route
Intravenous
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208375
Marketing start
Listing expires
Other FDA classes
Lipopeptides (Chemical structure)
Identifiers
Product ID 68001-376_48bb305c-30e8-669b-e063-6294a90a132cSPL ID 48bb305c-30e8-669b-e063-6294a90a132cSPL set ID d6c3df37-8481-46c2-8048-199bad37c933RxCUI 403920UNII NWQ5N31VKKUPC 0368001376686
Pharmacologic class
Lipopeptide 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.

How CPT relates to drug billing

NDC on a medical claim

N468001037668 followed by a unit qualifier and the quantity

Package 68001-0376-68. 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 .

Indications (excerpt from the label)

. Daptomycin for injection is a lipopeptide antibacterial indicated for the treatment of: Complicated skin and skin structure infections (cSSSI) in adult and pediatric patients (1 to 17 years of age) ( 1.1 ) and, Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis ( 1.2) Staphylococcus aureus bloodstream infections (bacteremia) in pediatric patients (1 to 17 years of age). ( 1.3 ) Limitations of Use : Daptomycin for injection is not indicated for the treatment of pneumonia. ( 1.4 ) Daptomycin for injection is not indicated for the treatment of left-sided infective endocarditis due to S. aureus . ( 1.4) Daptomyci…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 208375

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 208375
ProductStrengthForm · routeLabelerProduct NDC
DaptomycinDaptomycin 500 mg/10mLInjection, Powder, Lyophilized, For solutionIntravenousDr.Reddy's Laboratories Inc.,43598-413

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in