NDC 0941-0679
EXTRANEAL
Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride
EXTRANEAL is a Intraperitoneal Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Baxter Healthcare Corporation. The primary component is Icodextrin; Sodium Chloride; Sodium Lactate; Calcium Chloride; Magnesium Chloride.
| Product ID | 0941-0679_3ab6f82d-5a8d-4eaf-82b8-15be5ec3a1df |
| NDC | 0941-0679 |
| Product Type | Human Prescription Drug |
| Proprietary Name | EXTRANEAL |
| Generic Name | Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRAPERITONEAL |
| Marketing Start Date | 2002-12-20 |
| Marketing Category | NDA / NDA |
| Application Number | NDA021321 |
| Labeler Name | Baxter Healthcare Corporation |
| Substance Name | ICODEXTRIN; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE |
| Active Ingredient Strength | 8 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL |
| Pharm Classes | Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
Packaging
NDC 0941-0679-05
2500 mL in 1 BAG (0941-0679-05)
| Marketing Start Date | 2002-12-20 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0941-0679-48 [00941067948]
EXTRANEAL INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA021321 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2002-12-20 |
| Marketing End Date | 2014-12-18 |
NDC 0941-0679-52 [00941067952]
EXTRANEAL INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA021321 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2002-12-20 |
NDC 0941-0679-45 [00941067945]
EXTRANEAL INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA021321 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2002-12-20 |
| Marketing End Date | 2014-12-18 |
NDC 0941-0679-51 [00941067951]
EXTRANEAL INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA021321 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2002-12-20 |
| Marketing End Date | 2014-12-18 |
NDC 0941-0679-53 [00941067953]
EXTRANEAL INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA021321 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2002-12-20 |
NDC 0941-0679-06 [00941067906]
EXTRANEAL INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA021321 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2002-12-20 |
NDC 0941-0679-05 [00941067905]
EXTRANEAL INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA021321 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2002-12-20 |
NDC 0941-0679-47 [00941067947]
EXTRANEAL INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA021321 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2002-12-20 |
| Marketing End Date | 2014-12-18 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| ICODEXTRIN | 7.5 g/100mL |
OpenFDA Data
| SPL SET ID: | d5b85158-b0d6-4855-9d07-8d1b3ad9ab71 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Osmotic Laxative [EPC]
- Increased Large Intestinal Motility [PE]
- Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
- Osmotic Activity [MoA]
- Osmotic Laxative [EPC]
- Increased Large Intestinal Motility [PE]
- Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
- Osmotic Activity [MoA]
- Blood Coagulation Factor [EPC]
- Increased Coagulation Factor Activity [PE]
- Calcium [CS]
- Cations
- Divalent [CS]
- Calculi Dissolution Agent [EPC]
- Magnesium Ion Exchange Activity [MoA]
- Osmotic Laxative [EPC]
- Osmotic Activity [MoA]
- Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]
- Increased Large Intestinal Motility [PE]
- Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
- Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
Trademark Results [EXTRANEAL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EXTRANEAL 78566260 not registered Dead/Abandoned |
Baxter International Inc. 2005-02-13 |
 EXTRANEAL 76221877 not registered Dead/Abandoned |
Baxter International Inc. 2001-03-09 |
 EXTRANEAL 76221144 2843444 Live/Registered |
Baxter International Inc. 2001-03-08 |
 EXTRANEAL 75265684 not registered Dead/Abandoned |
Baxter International Inc. 1997-03-28 |
 EXTRANEAL 75250390 not registered Dead/Abandoned |
Baxter International Inc. 1997-03-03 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.