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NDC 00990-7965-09 NORMOSOL-M AND DEXTROSE 5; 21; 128; 234 g/100mL; mg/100mL; mg/100mL; mg/100mL Details
NORMOSOL-M AND DEXTROSE 5; 21; 128; 234 g/100mL; mg/100mL; mg/100mL; mg/100mL
NORMOSOL-M AND DEXTROSE is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by ICU Medical Inc.. The primary component is DEXTROSE MONOHYDRATE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE.
Product Information
| NDC | 00990-7965 |
|---|---|
| Product ID | 0990-7965_64d6879f-9673-4824-93c7-354e6f33d0a3 |
| Associated GPIs | 79993002752010 |
| GCN Sequence Number | 001960 |
| GCN Sequence Number Description | electrolyte-M solution/D5W IV SOLN 5 % INTRAVEN |
| HIC3 | C1W |
| HIC3 Description | ELECTROLYTE MAINTENANCE |
| GCN | 62540 |
| HICL Sequence Number | 014861 |
| HICL Sequence Number Description | ELECTROLYTE-M SOLUTION/DEXTROSE 5 % IN WATER |
| Brand/Generic | Brand |
| Proprietary Name | NORMOSOL-M AND DEXTROSE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | dextrose monohydrate, sodium chloride, potassium acetate, and magnesium acetate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 5; 21; 128; 234 |
| Active Ingredient Units | g/100mL; mg/100mL; mg/100mL; mg/100mL |
| Substance Name | DEXTROSE MONOHYDRATE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE |
| Labeler Name | ICU Medical Inc. |
| Pharmaceutical Class | Calculi Dissolution Agent [EPC], 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/E |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA017610 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00990-7965-09 (00990796509)
| NDC Package Code | 0990-7965-09 |
|---|---|
| Billing NDC | 00990796509 |
| Package | 12 POUCH in 1 CASE (0990-7965-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG |
| Marketing Start Date | 2021-02-08 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |