Prescription drug · NDA
Defencath (Taurolidine and heparin) NDC 72990-103
Taurolidine 40.5 mg/3mL; Heparin 3000 [USP'U]/3mL · Solution · Intraluminal · CorMedix Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72990-103-10 | 72990010310 | 10 VIAL, SINGLE-DOSE in 1 CARTON (72990-103-10) / 3 mL in 1 VIAL, SINGLE-DOSE (72990-103-03)Marketed from Apr 9, 2024 |
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)
- Defencath
- Generic name (nonproprietary)
- taurolidine and heparin
- Active ingredients
- Taurolidine — 40.5 mg/3mLHeparin — 3000 [USP'U]/3mL
- Dosage form
- Solution
- Route
- Intraluminal
- Labeler
- CorMedix Inc.NDC labeler code 72990
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 214520
- Marketing start
- Listing expires
- Other FDA classes
- Heparin (Chemical structure)
- Identifiers
- Product ID 72990-103_c4c34743-4c50-4dd2-836c-3669dcdcb349SPL ID c4c34743-4c50-4dd2-836c-3669dcdcb349SPL set ID 13b3a61e-5a4b-4afb-8fa1-d76ebdb344d6RxCUI 2670461, 2670468, 2670471, 2670472UNII 8OBZ1M4V3V, T2410KM04A
- Pharmacologic class
- Anti-coagulant; Unfractionated Heparin
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
N472990010310followed by a unit qualifier and the quantityPackage 72990-0103-10. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
LIMITED POPULATION: DEFENCATH ® is indicated to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC). This drug is indicated for use in a limited and specific population of patients [see Clinical Studies (14) ]. Limitations of Use The safety and effectiveness of DEFENCATH have not been established for use in populations other than adult patients with kidney failure receiving chronic HD through a CVC. LIMITED POPULATION: DEFENCATH is a combination of taurolidine, a thiadiazinane antimicrobial, and heparin, an anti-coagulant, indicated to reduce the incidence of …
Excerpt only. Read the full label for complete information.
About NDC 72990-103
- What is NDC 72990-103?
- 72990-103 is the product NDC for Defencath, Taurolidine 40.5 mg/3mL; Heparin 3000 [USP'U]/3mL solution, listed with the FDA by CorMedix Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Defencath (Taurolidine and heparin).
- What is the active ingredient?
- Taurolidine, Heparin.
- Who is the labeler?
- CorMedix Inc., NDC labeler code 72990. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Defencath?
- 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.