Normosol-R
- Product NDC
- 0990-7967
- 11-digit product format
- 009907967
- Labeler code
- 0990
- Product ID
- 0990-7967_3315ac00-862e-4bc3-af5b-b15a9894efa5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- ICU Medical Inc.
- Application
- NDA017586
- Marketing category
- NDA
- Marketing start
- 2019-09-18
- Substance
- MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE ANHYDROUS; SODIUM CHLORIDE; SODIUM GLUCONATE
- Active strength
- 30; 37; 222; 526; 502 mg/100mL; mg/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], 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 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 Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], 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-R
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MAGNESIUM CHLORIDE | 30 mg/100mL |
| POTASSIUM CHLORIDE | 37 mg/100mL |
| SODIUM ACETATE ANHYDROUS | 222 mg/100mL |
| SODIUM CHLORIDE | 526 mg/100mL |
| SODIUM GLUCONATE | 502 mg/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 02F3473H9O, 660YQ98I10, NVG71ZZ7P0, 451W47IQ8X, R6Q3791S76 |
| Rxcui | 800985, 800988 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0990-7967-09 | Normosol-R | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | | 8 |
| 0990-7967-09 | Normosol-R | 12 in 1 CASE | INJECTION, SOLUTION | 12 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0990-7967 | NORMOSOL-R (SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE) INJECTION, SOLUTION [ICU MEDICAL INC.] | 7 | Current NDC, Legacy NDC, 2 package rows | 20231130_189b8ac6-e346-454f-b501-7645590ca4f8.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 |
|---|
| 0990-7967-09 | 00990796709 | 12 POUCH in 1 CASE (0990-7967-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG | 12 pouch | 2019-09-18 | 0000-00-00 | No | No | Current |