Atomoxetine
- Product NDC
- 72603-438
- 11-digit product format
- 726030438
- Labeler code
- 72603
- Product ID
- 72603-438_47f097ff-7152-f861-e063-6294a90a795a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atomoxetine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- NorthStar RxLLC
- Application
- ANDA202682
- Marketing category
- ANDA
- Marketing start
- 2026-03-02
- Substance
- ATOMOXETINE HYDROCHLORIDE
- Active strength
- 40 mg/1
- 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
- Atomoxetine
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ATOMOXETINE HYDROCHLORIDE | 40 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 57WVB6I2W0 |
| Rxcui | 349591, 349592, 349593, 349594, 349595, 608139, 608143 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0d16f546-db6a-1939-50fc-d06382424c97 | Product name | 4 | 20210903 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72603-438-01 | Atomoxetine | 30 in 1 BOTTLE | CAPSULE | 30 | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 349591 | atomoxetine HCl 10 MG Oral Capsule | PSN | 14f2804d-2914-4dd9-86c0-d084fcfd7e50 | 1 |
| 608139 | atomoxetine HCl 100 MG Oral Capsule | PSN | 14f2804d-2914-4dd9-86c0-d084fcfd7e50 | 1 |
| 349592 | atomoxetine HCl 18 MG Oral Capsule | PSN | 14f2804d-2914-4dd9-86c0-d084fcfd7e50 | 1 |
| 349593 | atomoxetine HCl 25 MG Oral Capsule | PSN | 14f2804d-2914-4dd9-86c0-d084fcfd7e50 | 1 |
| 349594 | atomoxetine HCl 40 MG Oral Capsule | PSN | 14f2804d-2914-4dd9-86c0-d084fcfd7e50 | 1 |
| 349595 | atomoxetine HCl 60 MG Oral Capsule | PSN | 14f2804d-2914-4dd9-86c0-d084fcfd7e50 | 1 |
| 608143 | atomoxetine HCl 80 MG Oral Capsule | PSN | 14f2804d-2914-4dd9-86c0-d084fcfd7e50 | 1 |
| 349591 | atomoxetine 10 MG Oral Capsule | SCD | 14f2804d-2914-4dd9-86c0-d084fcfd7e50 | 1 |
| 608139 | atomoxetine 100 MG Oral Capsule | SCD | 14f2804d-2914-4dd9-86c0-d084fcfd7e50 | 1 |
| 349592 | atomoxetine 18 MG Oral Capsule | SCD | 14f2804d-2914-4dd9-86c0-d084fcfd7e50 | 1 |
| 349593 | atomoxetine 25 MG Oral Capsule | SCD | 14f2804d-2914-4dd9-86c0-d084fcfd7e50 | 1 |
| 349594 | atomoxetine 40 MG Oral Capsule | SCD | 14f2804d-2914-4dd9-86c0-d084fcfd7e50 | 1 |
| 349595 | atomoxetine 60 MG Oral Capsule | SCD | 14f2804d-2914-4dd9-86c0-d084fcfd7e50 | 1 |
| 608143 | atomoxetine 80 MG Oral Capsule | SCD | 14f2804d-2914-4dd9-86c0-d084fcfd7e50 | 1 |
| 349591 | atomoxetine 10 MG (as atomoxetine hydrochloride) Oral Capsule | SY | 14f2804d-2914-4dd9-86c0-d084fcfd7e50 | 1 |
| 608139 | atomoxetine 100 MG (as atomoxetine HCl) Oral Capsule | SY | 14f2804d-2914-4dd9-86c0-d084fcfd7e50 | 1 |
| 349592 | atomoxetine 18 MG (as atomoxetine hydrochloride) Oral Capsule | SY | 14f2804d-2914-4dd9-86c0-d084fcfd7e50 | 1 |
| 349593 | atomoxetine 25 MG (as atomoxetine hydrochloride) Oral Capsule | SY | 14f2804d-2914-4dd9-86c0-d084fcfd7e50 | 1 |
| 349594 | atomoxetine 40 MG (as atomoxetine hydrochloride) Oral Capsule | SY | 14f2804d-2914-4dd9-86c0-d084fcfd7e50 | 1 |
| 349595 | atomoxetine 60 MG (as atomoxetine hydrochloride) Oral Capsule | SY | 14f2804d-2914-4dd9-86c0-d084fcfd7e50 | 1 |
| 608143 | atomoxetine 80 MG (as atomoxetine hydrochloride) Oral Capsule | SY | 14f2804d-2914-4dd9-86c0-d084fcfd7e50 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 72603-438-01 | 72603043801 | 30 CAPSULE in 1 BOTTLE (72603-438-01) | 30 capsule | 2026-03-02 | No | No | Current |