Prescription drug · ANDA
atomoxetine NDC 50090-7462
Atomoxetine hydrochloride 40 mg/1 · Capsule · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-7462-0 | 50090746200 | 30 CAPSULE in 1 BOTTLE (50090-7462-0)Marketed from Nov 19, 2024 |
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 — 40 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 079019
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 50090-7462_4c906a42-f113-490e-871c-2e64ec9cb81aSPL ID 4c906a42-f113-490e-871c-2e64ec9cb81aSPL set ID f75bc8e2-8e8e-4883-be9c-b716842c5277RxCUI 349594UNII 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
N450090746200followed by a unit qualifier and the quantityPackage 50090-7462-00. 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 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-impulsive…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 079019
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 25 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7342 |
| atomoxetine | Atomoxetine hydrochloride 60 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2361 |
| atomoxetine | Atomoxetine hydrochloride 40 mg/1 | CapsuleOral | Northstar Rx LLC | 16714-758 |
| atomoxetine | Atomoxetine hydrochloride 10 mg/1 | CapsuleOral | Northstar Rx LLC | 16714-755 |
| atomoxetine | Atomoxetine hydrochloride 18 mg/1 | CapsuleOral | Northstar Rx LLC | 16714-756 |
| atomoxetine | Atomoxetine hydrochloride 25 mg/1 | CapsuleOral | Northstar Rx LLC | 16714-757 |
| atomoxetine | Atomoxetine hydrochloride 100 mg/1 | CapsuleOral | Northstar Rx LLC | 16714-761 |
| atomoxetine | Atomoxetine hydrochloride 60 mg/1 | CapsuleOral | Northstar Rx LLC | 16714-759 |
| atomoxetine | Atomoxetine hydrochloride 80 mg/1 | CapsuleOral | Northstar Rx LLC | 16714-760 |
| atomoxetine | Atomoxetine hydrochloride 60 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7397 |
| atomoxetine | Atomoxetine hydrochloride 100 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7463 |
| atomoxetine | Atomoxetine hydrochloride 18 mg/1 | CapsuleOral | Glenmark Pharmaceuticals Inc., USA | 68462-266 |
| atomoxetine | Atomoxetine hydrochloride 10 mg/1 | CapsuleOral | Glenmark Pharmaceuticals Inc., USA | 68462-265 |
| atomoxetine | Atomoxetine hydrochloride 80 mg/1 | CapsuleOral | Glenmark Pharmaceuticals Inc., USA | 68462-270 |
| atomoxetine | Atomoxetine hydrochloride 25 mg/1 | CapsuleOral | Glenmark Pharmaceuticals Inc., USA | 68462-267 |
| atomoxetine | Atomoxetine hydrochloride 40 mg/1 | CapsuleOral | Glenmark Pharmaceuticals Inc., USA | 68462-268 |
| atomoxetine | Atomoxetine hydrochloride 60 mg/1 | CapsuleOral | Glenmark Pharmaceuticals Inc., USA | 68462-269 |
| atomoxetine | Atomoxetine hydrochloride 100 mg/1 | CapsuleOral | Glenmark Pharmaceuticals Inc., USA | 68462-271 |