NDC 81583-100
ZTALMY
Ganaxolone
ZTALMY is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Marinus Pharmaceuticals, Inc.. The primary component is Ganaxolone.
| Product ID | 81583-100_76fb746f-e81a-49b8-aac7-b80f7900c654 |
| NDC | 81583-100 |
| Product Type | Human Prescription Drug |
| Proprietary Name | ZTALMY |
| Generic Name | Ganaxolone |
| Dosage Form | Suspension |
| Route of Administration | ORAL |
| Marketing Start Date | 2022-06-06 |
| Marketing Category | NDA / |
| Application Number | NDA215904 |
| Labeler Name | Marinus Pharmaceuticals, Inc. |
| Substance Name | GANAXOLONE |
| Active Ingredient Strength | 50 mg/mL |
| DEA Schedule | CV |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
Packaging
NDC 81583-100-01
1 BOTTLE, PLASTIC in 1 CARTON (81583-100-01) > 110 mL in 1 BOTTLE, PLASTIC
| Marketing Start Date | 2022-06-06 |
| NDC Exclude Flag | N |
| Sample Package? | N |
Drug Details
Trademark Results [ZTALMY]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ZTALMY 90046102 not registered Live/Pending |
Marinus Pharmaceuticals, Inc. 2020-07-10 |
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