Atomoxetine
- Product NDC
- 64380-478
- 11-digit product format
- 643800478
- Labeler code
- 64380
- Product ID
- 64380-478_27a196c2-92d8-4c4f-97e5-210ae78dedbe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atomoxetine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Strides Pharma Science Limited
- Application
- ANDA079021
- Marketing category
- ANDA
- Marketing start
- 2025-07-01
- Substance
- ATOMOXETINE HYDROCHLORIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Atomoxetine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ATOMOXETINE HYDROCHLORIDE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 57WVB6I2W0 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64380-478-01 | Atomoxetine | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | | 1 |
| 64380-478-02 | Atomoxetine | 500 in 1 BOTTLE, PLASTIC | CAPSULE | 500 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 64380-478-01 | 64380047801 | 30 CAPSULE in 1 BOTTLE, PLASTIC (64380-478-01) | 30 capsule | 2025-07-01 | No | No | Historical |
| 64380-478-02 | 64380047802 | 500 CAPSULE in 1 BOTTLE, PLASTIC (64380-478-02) | 500 capsule | 2025-07-01 | No | No | Historical |