ATONCY
- Product NDC
- 30698-456
- 11-digit product format
- 306980456
- Labeler code
- 30698
- Product ID
- 30698-456_4e746d28-ff24-2255-e063-6294a90a2c71
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atomoxetine hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Validus Pharmaceuticals LLC
- Application
- NDA220320
- Marketing category
- NDA
- Marketing start
- 2026-03-20
- Substance
- ATOMOXETINE HYDROCHLORIDE
- Active strength
- 4 mg/mL
- Pharmacologic classes
- Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ATONCY
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ATOMOXETINE HYDROCHLORIDE | 4 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 57WVB6I2W0 |
| Rxcui | 2739831, 2739837 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 30698-456-02 | ATONCY | 1 in 1 CARTON | SOLUTION | 1 | | 1 |
| 30698-456-02 | ATONCY | 100 mL in 1 BOTTLE, GLASS | SOLUTION | 100 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 30698-456-02 | 30698045602 | 1 BOTTLE, GLASS in 1 CARTON (30698-456-02) / 100 mL in 1 BOTTLE, GLASS | 2026-03-20 | No | No | Historical |