Normosol-R and Dextrose
- Product NDC
- 0990-7968
- 11-digit product format
- 009907968
- Labeler code
- 0990
- Product ID
- 0990-7968_5a7f3e54-763c-4883-adf2-cce92ee2137b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dextrose, Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, and Magnesium Chloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- ICU Medical Inc.
- Application
- NDA017609
- Marketing category
- NDA
- Marketing start
- 2020-05-14
- Substance
- DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE ANHYDROUS; SODIUM CHLORIDE; SODIUM GLUCONATE
- Active strength
- 5; 30; 37; 222; 526; 502 g/100mL; 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 and Dextrose
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXTROSE MONOHYDRATE | 5 g/100mL |
| 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 | LX22YL083G, 02F3473H9O, 660YQ98I10, NVG71ZZ7P0, 451W47IQ8X, R6Q3791S76 |
| Rxcui | 801024, 1189629 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0990-7968-09 | Normosol-R and Dextrose | 1000 mL in 1 BAG | INJECTION, SOLUTION | 1000 | | 13 |
| 0990-7968-09 | Normosol-R and Dextrose | 12 in 1 CASE | INJECTION, SOLUTION | 12 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0990-7968 | NORMOSOL-R AND DEXTROSE (DEXTROSE, SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE) INJECTION, SOLUTION [ICU MEDICAL INC.] | 11 | Current NDC, Legacy NDC, 2 package rows | 20250101_ead1fca3-eff4-478f-8a8f-67510f80151a.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 1189629 | Normosol-R in 5 % Dextrose Injectable Solution | PSN | ead1fca3-eff4-478f-8a8f-67510f80151a | 13 |
| 1189629 | glucose 50 MG/ML / magnesium chloride 0.00148 MEQ/ML / potassium chloride 0.00497 MEQ/ML / sodium acetate 0.027 MEQ/ML / sodium chloride 0.0899 MEQ/ML / sodium gluconate 5.02 MG/ML Injectable Solution [Normosol-R in 5 % Dextrose] | SBD | ead1fca3-eff4-478f-8a8f-67510f80151a | 13 |
| 801024 | glucose 50 MG/ML / magnesium chloride 0.00148 MEQ/ML / potassium chloride 0.00497 MEQ/ML / sodium acetate 0.027 MEQ/ML / sodium chloride 0.0899 MEQ/ML / sodium gluconate 5.02 MG/ML Injectable Solution | SCD | ead1fca3-eff4-478f-8a8f-67510f80151a | 13 |
| 801024 | Glucose 50 MG/ML / Magnesium Chloride 0.00148 MEQ/ML / K+ Chloride 0.00497 MEQ/ML / Sodium Acetate 0.027 MEQ/ML / NaCl 0.0899 MEQ/ML / Sodium gluconate 5.02 MG/ML Injectable Solution | SY | ead1fca3-eff4-478f-8a8f-67510f80151a | 13 |
| 1189629 | Glucose 50 MG/ML / Magnesium Chloride 0.00148 MEQ/ML / K+ Chloride 0.00497 MEQ/ML / Sodium Acetate 0.027 MEQ/ML / NaCl 0.0899 MEQ/ML / Sodium gluconate 5.02 MG/ML Injectable Solution [Normosol-R in 5 % Dextrose] | SY | ead1fca3-eff4-478f-8a8f-67510f80151a | 13 |
| 801024 | Glucose 50 MG/ML / Magnesium Chloride 0.00148 MEQ/ML / Pot Chloride 0.00497 MEQ/ML / Sodium Acetate 0.027 MEQ/ML / NaCl 0.0899 MEQ/ML / Sodium gluconate 5.02 MG/ML Injectable Solution | SY | ead1fca3-eff4-478f-8a8f-67510f80151a | 13 |
| 1189629 | Glucose 50 MG/ML / Magnesium Chloride 0.00148 MEQ/ML / Pot Chloride 0.00497 MEQ/ML / Sodium Acetate 0.027 MEQ/ML / NaCl 0.0899 MEQ/ML / Sodium gluconate 5.02 MG/ML Injectable Solution [Normosol-R in 5 % Dextrose] | SY | ead1fca3-eff4-478f-8a8f-67510f80151a | 13 |
| 1189629 | Normosol-R in 5 % Dextrose (glucose 50 MG/ML / K+ chloride 0.00497 MEQ/ML / magnesium chloride 0.00148 MEQ/ML / sodium acetate 0.027 MEQ/ML / sodium chloride 0.0899 MEQ/ML / sodium gluconate 5.02 MG/ML) Injectable Solution | SY | ead1fca3-eff4-478f-8a8f-67510f80151a | 13 |
| 1189629 | Normosol-R in 5 % Dextrose Injectable Solution | SY | ead1fca3-eff4-478f-8a8f-67510f80151a | 13 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0990-7968-09 | 00990796809 | 12 BAG in 1 CASE (0990-7968-09) / 1000 mL in 1 BAG | 12 bag | 2020-05-14 | 0000-00-00 | No | No | Current |