Prescription drug · NDA
Xacduro (Sulbactam and durlobactam) NDC 68547-111
Kit · La Jolla Pharmaceutical Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68547-111-10 | 68547011110 | 1 KIT in 1 CARTON (68547-111-10) * 5 mL in 1 VIAL, SINGLE-DOSE (68547-211-20) * 2.5 mL in 1 VIAL, SINGLE-DOSE (68547-311-30)Marketed from Jun 6, 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)
- Xacduro
- Generic name (nonproprietary)
- sulbactam and durlobactam
- Dosage form
- Kit
- Labeler
- La Jolla Pharmaceutical CompanyNDC labeler code 68547
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 216974
- Marketing start
- Listing expires
- Identifiers
- Product ID 68547-111_6806907c-e81f-4460-b0dc-8bf3b9d0123dSPL ID 6806907c-e81f-4460-b0dc-8bf3b9d0123d
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.
- NDC on a medical claim
N468547011110followed by a unit qualifier and the quantityPackage 68547-0111-10. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 68547-111
- What is NDC 68547-111?
- 68547-111 is the product NDC for Xacduro kit, listed with the FDA by La Jolla Pharmaceutical Company. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Xacduro (Sulbactam and durlobactam).
- Who is the labeler?
- La Jolla Pharmaceutical Company, NDC labeler code 68547. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Xacduro?
- 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.