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NDC 00941-0679-05 EXTRANEAL 25.7; 7.5; 5.08; 535; 448 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Details
EXTRANEAL 25.7; 7.5; 5.08; 535; 448 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL
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 CALCIUM CHLORIDE; ICODEXTRIN; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE.
Product Information
| NDC | 00941-0679 |
|---|---|
| Product ID | 0941-0679_6c892436-ebb2-4b32-bfa3-25fc48c1a4b4 |
| Associated GPIs | 99700040102020 |
| GCN Sequence Number | 061815 |
| GCN Sequence Number Description | peri.dialysis soln28-ico 7.5 % IP SOLN 3.5MEQ(CA) INTRAPERIT |
| HIC3 | C1Y |
| HIC3 Description | DIALYSIS SOLUTIONS |
| GCN | 97600 |
| HICL Sequence Number | 034246 |
| HICL Sequence Number Description | PERITONEAL DIALYSIS SOLUTION NO.28 WITH ICODEXTRIN 7.5 % |
| Brand/Generic | Brand |
| Proprietary Name | EXTRANEAL |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAPERITONEAL |
| Active Ingredient Strength | 25.7; 7.5; 5.08; 535; 448 |
| Active Ingredient Units | mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL |
| Substance Name | CALCIUM CHLORIDE; ICODEXTRIN; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
| Labeler Name | Baxter Healthcare Corporation |
| Pharmaceutical Class | 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 Intestin |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA021321 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00941-0679-05 (00941067905)
| NDC Package Code | 0941-0679-05 |
|---|---|
| Billing NDC | 00941067905 |
| Package | 2500 mL in 1 BAG (0941-0679-05) |
| Marketing Start Date | 2002-12-20 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |