Prescription drug · NDA
Kimyrsa (Oritavancin diphosphate) NDC 70842-225
Oritavancin diphosphate 1200 mg/40mL · Injection, Powder, Lyophilized, For solution · Intravenous · Melinta Therapeutics, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70842-225-01 | 70842022501 | 1 VIAL in 1 CARTON (70842-225-01) / 40 mL in 1 VIALMarketed from Mar 23, 2021 |
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)
- Kimyrsa
- Generic name (nonproprietary)
- oritavancin diphosphate
- Active ingredients
- Oritavancin diphosphate — 1200 mg/40mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Melinta Therapeutics, LLCNDC labeler code 70842
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 214155
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Cytochrome P450 2C9 Inhibitors (Mechanism)Cytochrome P450 2D6 Inducers (Mechanism)Cytochrome P450 3A4 Inducers (Mechanism)Lipoglycopeptides (Chemical structure)
- Identifiers
- Product ID 70842-225_25ae2ae5-afce-4475-bf3c-45323e93a952SPL ID 25ae2ae5-afce-4475-bf3c-45323e93a952SPL set ID 5e755c40-6e73-4572-b474-4d8a131693d1RxCUI 2532361, 2532366UNII VL1P93MKZNUPC 0370842225016
- Pharmacologic class
- Lipoglycopeptide 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
N470842022501followed by a unit qualifier and the quantityPackage 70842-0225-01. 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 .
Indications (excerpt from the label)
KIMYRSA is a lipoglycopeptide antibacterial drug indicated for the treatment of adult patients with acute bacterial skin and skin structure infections caused or suspected to be caused by susceptible isolates of designated Gram-positive microorganisms. ( 1.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of KIMYRSA and other antibacterial drugs, KIMYRSA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.2 ) 1.1 Acute Bacterial Skin and Skin Structure Infections KIMYRSA ® is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caus…
Excerpt only. Read the full label for complete information.
About NDC 70842-225
- What is NDC 70842-225?
- 70842-225 is the product NDC for Kimyrsa (oritavancin diphosphate), Oritavancin diphosphate 1200 mg/40mL injection, powder, lyophilized, for solution, listed with the FDA by Melinta Therapeutics, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Kimyrsa (Oritavancin diphosphate).
- What is the active ingredient?
- Oritavancin diphosphate.
- 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 Kimyrsa?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.