daptomycin NDC 14335-120

NDC codes

FDA NDC Directory

Product NDC (as listed)14335-120Labeler and product segments. Claims need a package NDC.

Product NDC at billing width14335-0120Add 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 NDC	11-digit (billing)	Package	Copy
14335-120-01	14335012001	20 mL in 1 VIAL, SINGLE-DOSE (14335-120-01)Marketed from Nov 14, 2023

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/20mL
Dosage form: Injection, Powder, Lyophilized, For suspension
Route: Intravenous
Labeler: Hainan Poly Pharm., Co., Ltd.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215890
Marketing start: Nov 14, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Lipopeptides (Chemical structure)
Identifiers: Product ID 14335-120_0a1a4553-120c-b67d-e063-6294a90a0572SPL ID 0a1a4553-120c-b67d-e063-6294a90a0572SPL set ID 6ec53f7e-9a5f-4b24-84e9-c94325750e32RxCUI 403920UNII NWQ5N31VKK
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

N414335012001 followed by a unit qualifier and the quantity

Package 14335-0120-01. 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 Nov 14, 2023.

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 215890

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

FDA NDC Directory listings under ANDA 215890
Product	Strength	Form · route	Labeler	Product NDC
daptomycin	Daptomycin 500 mg/20mL	Injection, Powder, Lyophilized, For suspensionIntravenous	Slate Run Pharmaceuticals, LLC	70436-033
daptomycin	Daptomycin 500 mg/20mL	Injection, Powder, Lyophilized, For suspensionIntravenous	Sintetica US LLC	83090-011