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NDC 16571-0723-12 SULFAMYLON 85 mg/g Details
SULFAMYLON 85 mg/g
SULFAMYLON is a TOPICAL CREAM in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Rising Pharma Holdings, Inc.. The primary component is MAFENIDE ACETATE.
Product Information
| NDC | 16571-0723 |
|---|---|
| Product ID | 16571-723_58d3a059-d175-4740-bf57-f156588c99b5 |
| Associated GPIs | 90450010103710 |
| GCN Sequence Number | 007668 |
| GCN Sequence Number Description | mafenide acetate CREAM (G) 8.5 % TOPICAL |
| HIC3 | Q5S |
| HIC3 Description | TOPICAL SULFONAMIDES |
| GCN | 31620 |
| HICL Sequence Number | 003346 |
| HICL Sequence Number Description | MAFENIDE ACETATE |
| Brand/Generic | Brand |
| Proprietary Name | SULFAMYLON |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | mafenide acetate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 85 |
| Active Ingredient Units | mg/g |
| Substance Name | MAFENIDE ACETATE |
| Labeler Name | Rising Pharma Holdings, Inc. |
| Pharmaceutical Class | Methylated Sulfonamide Antibacterial [EPC], Methylated Sulfonamides [EXT] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA016763 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 16571-0723-12 (16571072312)
| NDC Package Code | 16571-723-12 |
|---|---|
| Billing NDC | 16571072312 |
| Package | 1 TUBE in 1 CARTON (16571-723-12) / 113.4 g in 1 TUBE |
| Marketing Start Date | 2020-05-18 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |