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NDC 00941-0459-08 DIANEAL Low Calcium with Dextrose 18.3; 4.25; 5.08; 538; 448 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Details
DIANEAL Low Calcium with Dextrose 18.3; 4.25; 5.08; 538; 448 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL
DIANEAL Low Calcium with Dextrose 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; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE.
Product Information
| NDC | 00941-0459 |
|---|---|
| Product ID | 0941-0459_03e63a94-f195-48ab-8ca9-76c76fea5a18 |
| Associated GPIs | 99700000002070 |
| GCN Sequence Number | 053634 |
| GCN Sequence Number Description | periton.dialysis 8-4.25 % dext IP SOLN 2.5MEQ(CA) INTRAPERIT |
| HIC3 | C1Y |
| HIC3 Description | DIALYSIS SOLUTIONS |
| GCN | 21325 |
| HICL Sequence Number | 025924 |
| HICL Sequence Number Description | PERITONEAL DIALYSIS SOLUTION NO.8 WITH 4.25 % DEXTROSE |
| Brand/Generic | Brand |
| Proprietary Name | DIANEAL Low Calcium with Dextrose |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAPERITONEAL |
| Active Ingredient Strength | 18.3; 4.25; 5.08; 538; 448 |
| Active Ingredient Units | mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL |
| Substance Name | CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; 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 | NDA017512 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00941-0459-08 (00941045908)
| NDC Package Code | 0941-0459-08 |
|---|---|
| Billing NDC | 00941045908 |
| Package | 2000 mL in 1 BAG (0941-0459-08) |
| Marketing Start Date | 1978-09-27 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |