MAGNESIUM SULFATE
- Product NDC
- 68083-397
- 11-digit product format
- 680830397
- Labeler code
- 68083
- Product ID
- 68083-397_4166c4fd-2951-4ab0-ab2a-6da9dd39927e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MAGNESIUM SULFATE HEPTAHYDRATE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA213917
- Marketing category
- ANDA
- Marketing start
- 2020-07-10
- Substance
- MAGNESIUM SULFATE HEPTAHYDRATE
- Active strength
- 4 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MAGNESIUM SULFATE HEPTAHYDRATE | 4 g/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | SK47B8698T |
| Rxcui | 1658259, 1658262 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-397-01 | MAGNESIUM SULFATE | 24 in 1 CASE | INJECTION, SOLUTION | 24 | | 4 |
| 68083-397-01 | MAGNESIUM SULFATE | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-397 | MAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [GLAND PHARMA LIMITED] | 4 | Current NDC, Legacy NDC, 2 package rows | 20200715_a9e706ac-9c5f-4b14-b277-53dee195ffc6.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 |
|---|
| 68083-397-01 | 68083039701 | 24 POUCH in 1 CASE (68083-397-01) / 1 BAG in 1 POUCH / 100 mL in 1 BAG | 24 pouch | 2020-07-10 | 0000-00-00 | No | No | Current |