Prescription drug · NDA
Sivextro (Tedizolid phosphate) NDC 67919-041
Tedizolid phosphate 200 mg/1 · Tablet, Film coated · Oral · Merck Sharp & Dohme LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67919-041-04 | 67919004104 | 30 TABLET, FILM COATED in 1 BOTTLE (67919-041-04)Marketed from Jun 20, 2014 | |
| 67919-041-05 | 67919004105 | 1 BLISTER PACK in 1 CARTON (67919-041-05) / 6 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jun 20, 2014 |
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)
- Sivextro
- Generic name (nonproprietary)
- tedizolid phosphate
- Active ingredients
- Tedizolid phosphate — 200 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Merck Sharp & Dohme LLCNDC labeler code 67919
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 205435
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)Oxazolidinones (Chemical structure)
- Identifiers
- Product ID 67919-041_340a4655-ccf2-4c0f-a305-7576c06f4518SPL ID 340a4655-ccf2-4c0f-a305-7576c06f4518SPL set ID 75672079-589f-451a-bdbf-eaebcfcc80a9RxCUI 1540862, 1540868, 1540886, 1540890UNII O7DRJ6R4DW
- Pharmacologic class
- Oxazolidinone 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
N467919004104followed by a unit qualifier and the quantityPackage 67919-0041-04. 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)
SIVEXTRO is an oxazolidinone antibacterial indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible microorganisms in adult and pediatric patients (at least 26 weeks gestational age and weighing at least 1 kg) ( 1.1 ) Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of SIVEXTRO and other antibacterial drugs, SIVEXTRO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 1.1 Acute Bacterial Skin and Skin Structure Infections SIVEXTRO ® is indicated for the treatment of acute bac…
Excerpt only. Read the full label for complete information.
About NDC 67919-041
- What is NDC 67919-041?
- 67919-041 is the product NDC for Sivextro (tedizolid phosphate), Tedizolid phosphate 200 mg/1 tablet, film coated, listed with the FDA by Merck Sharp & Dohme LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sivextro (Tedizolid phosphate).
- What is the active ingredient?
- Tedizolid phosphate.
- Who is the labeler?
- Merck Sharp & Dohme LLC, NDC labeler code 67919. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sivextro?
- 1 other product NDC are listed under this name. See all Sivextro NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sivextro products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sivextrotedizolid phosphate | Tedizolid phosphate 200 mg/4mL | Injection, Powder, Lyophilized, For solutionIntravenous | Merck Sharp & Dohme LLC | 67919-040 | 67919-0040-02 |