Magnesium Sulfate in 5% Dextrose
- Product NDC
- 63323-108
- 11-digit product format
- 633230108
- Labeler code
- 63323
- Product ID
- 63323-108_bc4ffe6c-c0f9-4292-a17d-18e09df8ba28
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Magnesium Sulfate Heptahydrate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA206486
- Marketing category
- ANDA
- Marketing start
- 2016-03-07
- Substance
- MAGNESIUM SULFATE HEPTAHYDRATE
- Active strength
- 1 g/100mL
- Pharmacologic classes
- Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [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
- Magnesium Sulfate in 5% Dextrose
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MAGNESIUM SULFATE HEPTAHYDRATE | 1 g/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | SK47B8698T |
| Rxcui | 829757 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-108-00 | Magnesium Sulfate in 5% Dextrose | 100 mL in 1 BAG | INJECTION, SOLUTION | 100 | | 8 |
| 63323-108-01 | Magnesium Sulfate in 5% Dextrose | 24 in 1 CASE | INJECTION, SOLUTION | 24 | | 8 |
| 63323-108-02 | Magnesium Sulfate in 5% Dextrose | 100 mL in 1 BAG | INJECTION, SOLUTION | 100 | | 4 |
| 63323-108-26 | Magnesium Sulfate in 5% Dextrose | 24 in 1 CASE | INJECTION, SOLUTION | 24 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-108 | MAGNESIUM SULFATE IN 5% DEXTROSE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 8 | Current NDC, Legacy NDC, 2 package rows | 20240515_cea3f48b-375a-415a-a341-435c09719f7c.zip |
| 63323-108 | MAGNESIUM SULFATE IN 5% DEXTROSE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240515_fdffb339-89d1-4495-97b7-d9422d68b3d5.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 |
|---|
| 63323-108-00 | 63323010800 | 100 mL in 1 BAG | 100 ml | | | | | Historical |
| 63323-108-01 | 63323010801 | 24 BAG in 1 CASE (63323-108-01) / 100 mL in 1 BAG (63323-108-00) | 24 bag | 2016-03-07 | 0000-00-00 | No | No | Current |
| 63323-108-02 | 63323010802 | 100 mL in 1 BAG | 100 ml | | | | | Historical |
| 63323-108-26 | 63323010826 | 24 BAG in 1 CASE (63323-108-26) / 100 mL in 1 BAG (63323-108-02) | 24 bag | 2016-03-07 | 0000-00-00 | No | No | Current |