EXTRANEAL
- Product NDC
- 0941-0679
- 11-digit product format
- 009410679
- Labeler code
- 0941
- Product ID
- 0941-0679_8412c95a-1cc2-4ae7-baf9-3dc30d5b93a1
- 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
- Application
- NDA021321
- Marketing category
- NDA
- Marketing start
- 2002-12-20
- Substance
- CALCIUM CHLORIDE; ICODEXTRIN; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
- Active strength
- 25.7; 7.5; 5.08; 535; 448 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
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- EXTRANEAL
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CALCIUM CHLORIDE | 25.7 mg/100mL |
| ICODEXTRIN | 7.5 g/100mL |
| MAGNESIUM CHLORIDE | 5.08 mg/100mL |
| SODIUM CHLORIDE | 535 mg/100mL |
| SODIUM LACTATE | 448 mg/100mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | M4I0D6VV5M, 2NX48Z0A9G, 02F3473H9O, 451W47IQ8X, TU7HW0W0QT |
| Rxcui | 1100742, 1100746 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0941-0679-05 | EXTRANEAL | 2500 mL in 1 BAG | INJECTION, SOLUTION | 2500 | 24 | |
| 0941-0679-06 | EXTRANEAL | 2000 mL in 1 BAG | INJECTION, SOLUTION | 2000 | 24 | |
| 0941-0679-52 | EXTRANEAL | 2000 mL in 1 BAG | INJECTION, SOLUTION | 2000 | 24 | |
| 0941-0679-53 | EXTRANEAL | 2500 mL in 1 BAG | INJECTION, SOLUTION | 2500 | 24 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0941-0679-05 | ML - Milliliter | 0941-0679 | 2f88492c-d4fe-4c17-83c9-2e895e08297a | 1 | 2012-07-24 |
| 0941-0679-06 | ML - Milliliter | 0941-0679 | a0b309b1-a633-4e51-aff2-c40f0aaef270 | 1 | 2012-07-24 |
| 0941-0679-47 | ML - Milliliter | 0941-0679 | 9213c071-fac8-4525-925f-f10755ae4c96 | 1 | 2012-07-24 |
| 0941-0679-48 | ML - Milliliter | 0941-0679 | 864f04b1-3841-43f0-9c57-4d7d50af3bd8 | 1 | 2012-07-24 |
| 0941-0679-52 | ML - Milliliter | 0941-0679 | e0ce0d85-7e9e-4811-b8fb-a4fed61f2f84 | 1 | 2012-07-24 |
| 0941-0679-53 | ML - Milliliter | 0941-0679 | 6af9a164-091d-4bdd-9220-e9577883732b | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0941-0679 | EXTRANEAL (ICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE) INJECTION, SOLUTION [VANTIVE US HEALTHCARE LLC] | 23 | Current NDC, Legacy NDC, 4 package rows | 20250313_d5b85158-b0d6-4855-9d07-8d1b3ad9ab71.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1100746 | Extraneal 0.00232 MEQ/mL / 75 MG/mL / 0.000533 MEQ/mL / 0.0915 MEQ/mL / 0.04 MEQ/mL Injectable Solution | PSN | d5b85158-b0d6-4855-9d07-8d1b3ad9ab71 | 24 |
| 1100746 | calcium chloride 0.00232 MEQ/ML / icodextrin 75 MG/ML / magnesium chloride 0.000533 MEQ/ML / sodium chloride 0.0915 MEQ/ML / sodium lactate 0.04 MEQ/ML Injectable Solution [Extraneal] | SBD | d5b85158-b0d6-4855-9d07-8d1b3ad9ab71 | 24 |
| 1100742 | calcium chloride 0.00232 MEQ/ML / icodextrin 75 MG/ML / magnesium chloride 0.000533 MEQ/ML / sodium chloride 0.0915 MEQ/ML / sodium lactate 0.04 MEQ/ML Injectable Solution | SCD | d5b85158-b0d6-4855-9d07-8d1b3ad9ab71 | 24 |
| 1100742 | Calcium Chloride 0.00232 MEQ/ML / icodextrin 75 MG/ML / Magnesium Chloride 0.000533 MEQ/ML / NaCl 0.0915 MEQ/ML / Sodium Lactate 0.04 MEQ/ML Injectable Solution | SY | d5b85158-b0d6-4855-9d07-8d1b3ad9ab71 | 24 |
| 1100746 | Calcium Chloride 0.00232 MEQ/ML / icodextrin 75 MG/ML / Magnesium Chloride 0.000533 MEQ/ML / NaCl 0.0915 MEQ/ML / Sodium Lactate 0.04 MEQ/ML Injectable Solution [Extraneal] | SY | d5b85158-b0d6-4855-9d07-8d1b3ad9ab71 | 24 |
| 1100746 | Extraneal (calcium chloride 25.7 MG / icodextrin 7.5 GM / magnesium chloride 5.08 MG / sodium chloride 535 MG / sodium lactate 448 MG) per 100 ML Intraperitoneal Solution | SY | d5b85158-b0d6-4855-9d07-8d1b3ad9ab71 | 24 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0941-0679-05 | 00941067905 | 2500 mL in 1 BAG (0941-0679-05) | 2500 ml | 2002-12-20 | 0000-00-00 | No | No | Current |
| 0941-0679-06 | 00941067906 | 2000 mL in 1 BAG (0941-0679-06) | 2000 ml | 2002-12-20 | 0000-00-00 | No | No | Current |
| 0941-0679-52 | 00941067952 | 2000 mL in 1 BAG (0941-0679-52) | 2000 ml | 2002-12-20 | 0000-00-00 | No | No | Current |
| 0941-0679-53 | 00941067953 | 2500 mL in 1 BAG (0941-0679-53) | 2500 ml | 2002-12-20 | 0000-00-00 | No | No | Current |