Dextrose and Sodium Chloride
- Product NDC
- 63323-867
- 11-digit product format
- 633230867
- Labeler code
- 63323
- Product ID
- 63323-867_ee6bbc93-9dcb-4d7f-afe3-4588b0566d15
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DEXTROSE MONOHYDRATE and SODIUM CHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA211194
- Marketing category
- ANDA
- Marketing start
- 2020-10-26
- Substance
- DEXTROSE MONOHYDRATE; SODIUM CHLORIDE
- Active strength
- 5; .3 g/100mL; g/100mL
- Pharmacologic classes
- Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dextrose and Sodium Chloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXTROSE MONOHYDRATE | 5 g/100mL |
| SODIUM CHLORIDE | .3 g/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | LX22YL083G, 451W47IQ8X |
| Rxcui | 1795147, 1795149, 1795150 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-867-10 | Dextrose and Sodium Chloride | 1000 mL in 1 BAG | INJECTION, SOLUTION | 1000 | | 3 |
| 63323-867-10 | Dextrose and Sodium Chloride | 10 in 1 CASE | INJECTION, SOLUTION | 10 | | 3 |
| 63323-867-74 | Dextrose and Sodium Chloride | 500 mL in 1 BAG | INJECTION, SOLUTION | 500 | | 3 |
| 63323-867-74 | Dextrose and Sodium Chloride | 20 in 1 CASE | INJECTION, SOLUTION | 20 | | 3 |
| 63323-867-75 | Dextrose and Sodium Chloride | 30 in 1 CASE | INJECTION, SOLUTION | 30 | | 3 |
| 63323-867-75 | Dextrose and Sodium Chloride | 250 mL in 1 BAG | INJECTION, SOLUTION | 250 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-867 | DEXTROSE AND SODIUM CHLORIDE (DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 2 | Current NDC, Legacy NDC, 6 package rows | 20250419_99c6a1a9-cadf-435b-a332-ccc189afdfa9.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 |
|---|
| 63323-867-10 | 63323086710 | 10 BAG in 1 CASE (63323-867-10) / 1000 mL in 1 BAG | 10 bag | 2020-10-26 | 0000-00-00 | No | No | Current |
| 63323-867-74 | 63323086774 | 20 BAG in 1 CASE (63323-867-74) / 500 mL in 1 BAG | 20 bag | 2020-10-26 | 0000-00-00 | No | No | Current |
| 63323-867-75 | 63323086775 | 30 BAG in 1 CASE (63323-867-75) / 250 mL in 1 BAG | 30 bag | 2020-10-26 | 0000-00-00 | No | No | Current |