DEFENCATH
- Product NDC
- 72990-103
- 11-digit product format
- 729900103
- Labeler code
- 72990
- Product ID
- 72990-103_7691bd08-693e-4662-b095-6f19f154c2ae
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- taurolidine and heparin
- Dosage form
- SOLUTION
- Route
- INTRALUMINAL
- Labeler
- CorMedix Inc.
- Application
- NDA214520
- Marketing category
- NDA
- Marketing start
- 2024-04-09
- Substance
- HEPARIN; TAUROLIDINE
- Active strength
- 3000; 40.5 [USP'U]/3mL; mg/3mL
- Pharmacologic classes
- Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DEFENCATH
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HEPARIN | 3000 [USP'U]/3mL |
| TAUROLIDINE | 40.5 mg/3mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | T2410KM04A, 8OBZ1M4V3V |
| Rxcui | 2670461, 2670468, 2670471, 2670472 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72990-103-03 | DEFENCATH | 3 mL in 1 VIAL, SINGLE-DOSE | SOLUTION | 3 | | 7 |
| 72990-103-10 | DEFENCATH | 10 in 1 CARTON | SOLUTION | 10 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72990-103 | DEFENCATH (TAUROLIDINE AND HEPARIN) SOLUTION [CORMEDIX INC.] | 6 | Current NDC, 2 package rows | 20241228_13b3a61e-5a4b-4afb-8fa1-d76ebdb344d6.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 2670468 | DEFENCATH 3000 UNT / 40.5 MG in 3 ML Injection | PSN | 13b3a61e-5a4b-4afb-8fa1-d76ebdb344d6 | 7 |
| 2670472 | DEFENCATH 5000 UNT / 67.5 MG in 5 ML Injection | PSN | 13b3a61e-5a4b-4afb-8fa1-d76ebdb344d6 | 7 |
| 2670461 | heparin sodium, porcine 3,000 UNT / taurolidine 40.5 MG in 3 ML Injection | PSN | 13b3a61e-5a4b-4afb-8fa1-d76ebdb344d6 | 7 |
| 2670471 | heparin sodium, porcine 5,000 UNT / taurolidine 67.5 MG in 5 ML Injection | PSN | 13b3a61e-5a4b-4afb-8fa1-d76ebdb344d6 | 7 |
| 2670468 | 3 ML heparin sodium, porcine 1000 UNT/ML / taurolidine 13.5 MG/ML Injection [Defencath] | SBD | 13b3a61e-5a4b-4afb-8fa1-d76ebdb344d6 | 7 |
| 2670472 | 5 ML heparin sodium, porcine 1000 UNT/ML / taurolidine 13.5 MG/ML Injection [Defencath] | SBD | 13b3a61e-5a4b-4afb-8fa1-d76ebdb344d6 | 7 |
| 2670461 | 3 ML heparin sodium, porcine 1000 UNT/ML / taurolidine 13.5 MG/ML Injection | SCD | 13b3a61e-5a4b-4afb-8fa1-d76ebdb344d6 | 7 |
| 2670471 | 5 ML heparin sodium, porcine 1000 UNT/ML / taurolidine 13.5 MG/ML Injection | SCD | 13b3a61e-5a4b-4afb-8fa1-d76ebdb344d6 | 7 |
| 2670468 | Defencath (heparin sodium, porcine 3,000 UNT / taurolidine 40.5 MG) per 3 ML Injection | SY | 13b3a61e-5a4b-4afb-8fa1-d76ebdb344d6 | 7 |
| 2670472 | Defencath (heparin sodium, porcine 5,000 UNT / taurolidine 67.5 MG) per 5 ML Injection | SY | 13b3a61e-5a4b-4afb-8fa1-d76ebdb344d6 | 7 |
| 2670461 | heparin sodium, porcine 3,000 UNT / taurolidine 40.5 MG per 3 ML Injection | SY | 13b3a61e-5a4b-4afb-8fa1-d76ebdb344d6 | 7 |
| 2670471 | heparin sodium, porcine 5,000 UNT / taurolidine 67.5 MG per 5 ML Injection | SY | 13b3a61e-5a4b-4afb-8fa1-d76ebdb344d6 | 7 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72990-103-03 | 72990010303 | 3 mL in 1 VIAL, SINGLE-DOSE | 3 ml | | | | Historical |
| 72990-103-10 | 72990010310 | 10 VIAL, SINGLE-DOSE in 1 CARTON (72990-103-10) / 3 mL in 1 VIAL, SINGLE-DOSE (72990-103-03) | | 2024-04-09 | No | No | Historical |