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NDC 00990-7967-09 Normosol-R 30; 37; 222; 526; 502 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Details
Normosol-R 30; 37; 222; 526; 502 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL
Normosol-R is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by ICU Medical Inc.. The primary component is MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE ANHYDROUS; SODIUM CHLORIDE; SODIUM GLUCONATE.
Product Information
| NDC | 00990-7967 |
|---|---|
| Product ID | 0990-7967_c45fe05f-68f6-41b6-8a1a-448756d98e72 |
| Associated GPIs | 79992001752000 |
| GCN Sequence Number | 001449 |
| GCN Sequence Number Description | electrolyte-R solution IV SOLN INTRAVEN |
| HIC3 | C1W |
| HIC3 Description | ELECTROLYTE MAINTENANCE |
| GCN | 04320 |
| HICL Sequence Number | 000620 |
| HICL Sequence Number Description | ELECTROLYTE-R SOLUTION |
| Brand/Generic | Brand |
| Proprietary Name | Normosol-R |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 30; 37; 222; 526; 502 |
| Active Ingredient Units | mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL |
| Substance Name | MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE ANHYDROUS; SODIUM CHLORIDE; SODIUM GLUCONATE |
| 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], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition L |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA017586 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00990-7967-09 (00990796709)
| NDC Package Code | 0990-7967-09 |
|---|---|
| Billing NDC | 00990796709 |
| Package | 12 POUCH in 1 CASE (0990-7967-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG |
| Marketing Start Date | 2019-09-18 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |