Magnesium Sulfate in Water
- Product NDC
- 83634-501
- 11-digit product format
- 836340501
- Labeler code
- 83634
- Product ID
- 83634-501_74a0488c-befd-4f6b-af07-d06834e8202a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- magnesium sulfate in water
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Avenacy, LLC
- Application
- ANDA209642
- Marketing category
- ANDA
- Marketing start
- 2024-04-22
- 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 in Water
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83634-501-41 | Magnesium Sulfate in Water | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | | 4 |
| 83634-501-41 | Magnesium Sulfate in Water | 50 mL in 1 BAG | INJECTION, SOLUTION | 50 | | 4 |
| 83634-501-81 | Magnesium Sulfate in Water | 24 in 1 CARTON | INJECTION, SOLUTION | 24 | | 4 |
| 83634-501-82 | Magnesium Sulfate in Water | 30 in 1 CARTON | INJECTION, SOLUTION | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83634-501 | MAGNESIUM SULFATE IN WATER INJECTION, SOLUTION [AVENACY INC.] | 3 | Current NDC, 4 package rows | 20241115_f50f4e06-288c-4b5e-9260-f3fe0a210c0c.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 |
|---|
| 83634-501-41 | 83634050141 | 1 in 1 POUCH | | | | | Historical |
| 83634-501-81 | 83634050181 | 24 POUCH in 1 CARTON (83634-501-81) / 1 BAG in 1 POUCH (83634-501-41) / 50 mL in 1 BAG | 24 pouch | 2024-04-22 | No | No | Current |
| 83634-501-82 | 83634050182 | 30 POUCH in 1 CARTON (83634-501-82) / 1 BAG in 1 POUCH (83634-501-41) / 50 mL in 1 BAG | 30 pouch | 2025-09-15 | No | No | Current |