Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral
- Product NDC
- 64380-116
- 11-digit product format
- 643800116
- Labeler code
- 64380
- Product ID
- 64380-116_2c66ebff-4389-49f9-a6ed-39d7de46dcb5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Strides Pharma Science Limited
- Application
- ANDA215469
- Marketing category
- ANDA
- Marketing start
- 2024-01-17
- Substance
- MAGNESIUM SULFATE, UNSPECIFIED FORM; POTASSIUM SULFATE; SODIUM SULFATE
- Active strength
- 1.6; 3.13; 17.5 g/177mL; g/177mL; g/177mL
- Pharmacologic classes
- Calculi Dissolution Agent [EPC], 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 Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], 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
- Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MAGNESIUM SULFATE, UNSPECIFIED FORM | 1.6 g/177mL |
| POTASSIUM SULFATE | 3.13 g/177mL |
| SODIUM SULFATE | 17.5 g/177mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | DE08037SAB, 1K573LC5TV, 0YPR65R21J |
| Rxcui | 1120068 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64380-116-01 | Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral | 2 in 1 CARTON | SOLUTION | 2 | | 4 |
| 64380-116-02 | Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral | 177 mL in 1 BOTTLE | SOLUTION | 177 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64380-116 | SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE ORAL SOLUTION [STRIDES PHARMA SCIENCE LIMITED] | 4 | Current NDC, 2 package rows | 20250316_d48d8c59-68b9-4e28-86a4-eabf8b2003b0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 64380-116-01 | 64380011601 | 2 BOTTLE in 1 CARTON (64380-116-01) / 177 mL in 1 BOTTLE (64380-116-02) | 2 bottle | 2024-01-17 | No | No | Current |
| 64380-116-02 | 64380011602 | 177 mL in 1 BOTTLE | 177 ml | | | | Historical |