EXTRANEAL
- Product NDC
- 0941-0681
- 11-digit product format
- 009410681
- Labeler code
- 0941
- Product ID
- 0941-0681_348e030f-39eb-ac7c-e063-6394a90a4602
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAPERITONEAL
- Labeler
- Vantive US Healthcare LLC
- Marketing category
- UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
- Marketing start
- 2024-10-21
- Marketing end
- 2026-11-30
- Substance
- CALCIUM CHLORIDE; ICODEXTRIN; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
- Active strength
- 25.7; 7.5; 5.1; 540; 450 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL
- Pharmacologic classes
- Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- EXTRANEAL
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CALCIUM CHLORIDE | 25.7 mg/100mL |
| ICODEXTRIN | 7.5 g/100mL |
| MAGNESIUM CHLORIDE | 5.1 mg/100mL |
| SODIUM CHLORIDE | 540 mg/100mL |
| SODIUM LACTATE | 450 mg/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2NX48Z0A9G, M4I0D6VV5M, TU7HW0W0QT, 451W47IQ8X, 02F3473H9O |
| Rxcui | 1100742, 1100746 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0941-0681-02 | EXTRANEAL | 2500 mL in 1 BAG | INJECTION, SOLUTION | 2500 | | 6 |
| 0941-0681-08 | EXTRANEAL | 4 in 1 CARTON | INJECTION, SOLUTION | 4 | | 6 |
| 0941-0681-01 | EXTRANEAL | 2500 mL in 1 BAG | INJECTION, SOLUTION | 2500 | | 5 |
| 0941-0681-04 | EXTRANEAL | 4 in 1 CARTON | INJECTION, SOLUTION | 4 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0941-0681 | EXTRANEAL (ICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE) INJECTION, SOLUTION [VANTIVE US HEALTHCARE LLC] | 6 | Current NDC, 2 package rows | 20250508_2b327b13-a0e9-4b2c-9875-4470998e2e30.zip |
| 0941-0681 | EXTRANEAL (ICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE) INJECTION, SOLUTION [VANTIVE US HEALTHCARE LLC] | 5 | Current NDC, 2 package rows | 20250508_e18bacfe-af60-49dc-bd30-cb3c29fa16db.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0941-0681-01 | 00941068101 | 2500 mL in 1 BAG | 2500 ml | | | | | Historical |
| 0941-0681-02 | 00941068102 | 2500 mL in 1 BAG | 2500 ml | | | | | Historical |
| 0941-0681-04 | 00941068104 | 4 BAG in 1 CARTON (0941-0681-04) / 2500 mL in 1 BAG (0941-0681-01) | 4 bag | 2024-10-21 | 2026-11-30 | No | No | Historical |
| 0941-0681-08 | 00941068108 | 4 BAG in 1 CARTON (0941-0681-08) / 2500 mL in 1 BAG (0941-0681-02) | 4 bag | 2024-10-21 | 2027-01-31 | No | No | Historical |