NORMOSOL-M AND DEXTROSE
- Product NDC
- 0990-7965
- 11-digit product format
- 009907965
- Labeler code
- 0990
- Product ID
- 0990-7965_82c807c8-da31-4166-803f-a194b26dd1dc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dextrose monohydrate, sodium chloride, potassium acetate, and magnesium acetate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- ICU Medical Inc.
- Application
- NDA017610
- Marketing category
- NDA
- Marketing start
- 2021-02-08
- Substance
- DEXTROSE MONOHYDRATE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE
- Active strength
- 5; 21; 128; 234 g/100mL; mg/100mL; mg/100mL; mg/100mL
- Pharmacologic classes
- 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/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- NORMOSOL-M AND DEXTROSE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXTROSE MONOHYDRATE | 5 g/100mL |
| MAGNESIUM ACETATE | 21 mg/100mL |
| POTASSIUM ACETATE | 128 mg/100mL |
| SODIUM CHLORIDE | 234 mg/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | LX22YL083G, 0E95JZY48K, M911911U02, 451W47IQ8X |
| Rxcui | 801005, 801009 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0990-7965-09 | NORMOSOL-M AND DEXTROSE | 12 in 1 CASE | INJECTION, SOLUTION | 12 | | 11 |
| 0990-7965-09 | NORMOSOL-M AND DEXTROSE | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0990-7965 | NORMOSOL-M AND DEXTROSE (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, POTASSIUM ACETATE, AND MAGNESIUM ACETATE) INJECTION, SOLUTION [ICU MEDICAL INC.] | 9 | Current NDC, Legacy NDC, 2 package rows | 20241109_aba60c84-94d9-46d0-bdbb-25e0c4e8cc41.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0990-7965-09 | 00990796509 | 12 POUCH in 1 CASE (0990-7965-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG | 12 pouch | 2021-02-08 | 0000-00-00 | No | No | Current |