ZTALMY
- Product NDC
- 81583-100
- 11-digit product format
- 815830100
- Labeler code
- 81583
- Product ID
- 81583-100_44a8cd9a-8b14-93c2-e063-6394a90aef51
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ganaxolone
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Immedica Pharma US Inc
- Application
- NDA215904
- Marketing category
- NDA
- Marketing start
- 2022-06-06
- Substance
- GANAXOLONE
- Active strength
- 50 mg/mL
- Pharmacologic classes
- GABA A Receptor Positive Modulators [MoA], Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]
- DEA schedule
- CV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ZTALMY
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GANAXOLONE | 50 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 98WI44OHIQ |
| Rxcui | 2604694, 2604700 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 81583-100-01 | ZTALMY | 1 in 1 CARTON | SUSPENSION | 1 | | 13 |
| 81583-100-01 | ZTALMY | 110 mL in 1 BOTTLE, PLASTIC | SUSPENSION | 110 | | 13 |
| 81583-100-05 | ZTALMY | 110 mL in 1 BOTTLE, PLASTIC | SUSPENSION | 110 | | 13 |
| 81583-100-05 | ZTALMY | 5 in 1 CARTON | SUSPENSION | 5 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 81583-100 | ZTALMY (GANAXOLONE) SUSPENSION [IMMEDICA PHARMA US INC] | 9 | Current NDC, Legacy NDC, 4 package rows | 20250521_d91612c4-b03a-4be4-a1ee-6a13e3b83d4e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 81583-100-01 | 81583010001 | 1 BOTTLE, PLASTIC in 1 CARTON (81583-100-01) / 110 mL in 1 BOTTLE, PLASTIC | 2022-06-06 | 0000-00-00 | No | No | Current |
| 81583-100-05 | 81583010005 | 5 BOTTLE, PLASTIC in 1 CARTON (81583-100-05) > 110 mL in 1 BOTTLE, PLASTIC | 2022-06-06 | 0000-00-00 | No | No | Current |