magnesium sulfate
- Product NDC
- 63323-107
- 11-digit product format
- 633230107
- Labeler code
- 63323
- Product ID
- 63323-107_48486022-130e-4a6a-87e7-db7c53eb5e75
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MAGNESIUM SULFATE HEPTAHYDRATE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA206485
- Marketing category
- ANDA
- Marketing start
- 2016-03-15
- Substance
- MAGNESIUM SULFATE HEPTAHYDRATE
- Active strength
- 80 mg/mL
- 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MAGNESIUM SULFATE HEPTAHYDRATE | 80 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | SK47B8698T |
| Rxcui | 829734, 1658259, 1658262, 1658264, 1658265 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-107-01 | magnesium sulfate | 50 mL in 1 BAG | INJECTION, SOLUTION | 50 | | 6 |
| 63323-107-05 | magnesium sulfate | 24 in 1 CASE | INJECTION, SOLUTION | 24 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-107 | MAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20240427_fef9e18c-5210-4090-b564-4950ebe461c0.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 |
|---|
| 63323-107-01 | 63323010701 | 50 mL in 1 BAG | 50 ml | | | | | Historical |
| 63323-107-05 | 63323010705 | 24 BAG in 1 CASE (63323-107-05) / 50 mL in 1 BAG (63323-107-01) | 24 bag | 2016-03-15 | 0000-00-00 | No | No | Current |