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NDC 50438-0001-00 ROYAL Epsom Salt 1 kg/kg Details
ROYAL Epsom Salt 1 kg/kg
ROYAL Epsom Salt is a ORAL GRANULE, FOR SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Filo America. The primary component is MAGNESIUM SULFATE, UNSPECIFIED FORM.
Product Information
| NDC | 50438-0001 |
|---|---|
| Product ID | 50438-001_08c11030-7bab-55ae-e063-6394a90a1437 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | ROYAL Epsom Salt |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Magnesium Sulfate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | GRANULE, FOR SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 1 |
| Active Ingredient Units | kg/kg |
| Substance Name | MAGNESIUM SULFATE, UNSPECIFIED FORM |
| Labeler Name | Filo America |
| Pharmaceutical Class | 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 |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH DRUG |
| Application Number | M007 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 50438-0001-00 (50438000100)
| NDC Package Code | 50438-001-00 |
|---|---|
| Billing NDC | 50438000100 |
| Package | 1.8 kg in 1 BAG (50438-001-00) |
| Marketing Start Date | 2014-10-29 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |