Prescription drug · ANDA
Atomoxetine NDC 50090-6511
Atomoxetine hydrochloride 80 mg/1 · Capsule · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-6511-0 | 50090651100 | 30 CAPSULE in 1 BOTTLE (50090-6511-0)Marketed from May 31, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Atomoxetine
- Generic name (nonproprietary)
- atomoxetine
- Active ingredients
- Atomoxetine hydrochloride — 80 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079022
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 50090-6511_c69ae8cb-d0e7-444f-a102-ebc42e6609a4SPL ID c69ae8cb-d0e7-444f-a102-ebc42e6609a4SPL set ID ddec2943-483d-403a-838c-cbdb6eefe0a1RxCUI 608143UNII 57WVB6I2W0
- Pharmacologic class
- Norepinephrine Reuptake Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N450090651100followed by a unit qualifier and the quantityPackage 50090-6511-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Atomoxetine capsules are a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). ( 1.1 ) 1.1 Attention-Deficit/Hyperactivity Disorder (ADHD) Atomoxetine capsules are indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). The efficacy of atomoxetine capsules was established in seven clinical trials in outpatients with ADHD: four 6 to 9-week trials in pediatric patients (ages 6 to 18), two 10-week trial in adults, and one maintenance trial in pediatrics (ages 6 to 15) [ see Clinical Studies ( 14 ) ]. 1.2 Diagnostic Considerations A diagnosis of ADHD (DSM-IV) implies the presence of hyperactive-impuls…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 079022
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Atomoxetine | Atomoxetine hydrochloride 80 mg/1 | CapsuleOral | Teva Pharmaceuticals USA, Inc. | 0093-3547 |
| Atomoxetine | Atomoxetine hydrochloride 60 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6254 |
| Atomoxetine | Atomoxetine hydrochloride 100 mg/1 | CapsuleOral | Teva Pharmaceuticals USA, Inc. | 0093-3548 |
| Atomoxetine | Atomoxetine hydrochloride 40 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6289 |
| Atomoxetine | Atomoxetine hydrochloride 25 mg/1 | CapsuleOral | AvKARE | 42291-066 |
| Atomoxetine | Atomoxetine hydrochloride 10 mg/1 | CapsuleOral | AvKARE | 42291-064 |
| Atomoxetine | Atomoxetine hydrochloride 18 mg/1 | CapsuleOral | AvKARE | 42291-065 |
| Atomoxetine | Atomoxetine hydrochloride 100 mg/1 | CapsuleOral | AvKARE | 42291-070 |
| Atomoxetine | Atomoxetine hydrochloride 40 mg/1 | CapsuleOral | AvKARE | 42291-067 |
| Atomoxetine | Atomoxetine hydrochloride 60 mg/1 | CapsuleOral | AvKARE | 42291-068 |
| Atomoxetine | Atomoxetine hydrochloride 80 mg/1 | CapsuleOral | AvKARE | 42291-069 |
| Atomoxetine | Atomoxetine hydrochloride 25 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6512 |
| Atomoxetine | Atomoxetine hydrochloride 10 mg/1 | CapsuleOral | Teva Pharmaceuticals USA, Inc. | 0093-3542 |
| Atomoxetine | Atomoxetine hydrochloride 18 mg/1 | CapsuleOral | Teva Pharmaceuticals USA, Inc. | 0093-3543 |
| Atomoxetine | Atomoxetine hydrochloride 25 mg/1 | CapsuleOral | Teva Pharmaceuticals USA, Inc. | 0093-3544 |
| Atomoxetine | Atomoxetine hydrochloride 40 mg/1 | CapsuleOral | Teva Pharmaceuticals USA, Inc. | 0093-3545 |
| Atomoxetine | Atomoxetine hydrochloride 60 mg/1 | CapsuleOral | Teva Pharmaceuticals USA, Inc. | 0093-3546 |