Prescription drug · ANDA
Atomoxetine NDC 64380-478
Atomoxetine hydrochloride 100 mg/1 · Capsule · Oral · Strides Pharma Science Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64380-478-01 | 64380047801 | 30 CAPSULE in 1 BOTTLE, PLASTIC (64380-478-01)Marketed from Jul 1, 2025 | |
| 64380-478-02 | 64380047802 | 500 CAPSULE in 1 BOTTLE, PLASTIC (64380-478-02)Marketed from Jul 1, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079021
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 64380-478_94ef88bd-e176-4c16-9340-ae0168422053SPL ID 94ef88bd-e176-4c16-9340-ae0168422053SPL set ID 2614df7e-0b16-4b03-883e-141d4ec34b35RxCUI 349591, 349592, 349593, 349594, 349595, 608139, 608143UNII 57WVB6I2W0UPC 0364380475019, 0364380478010, 0364380476016, 0364380477013
- 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
N464380047801followed by a unit qualifier and the quantityPackage 64380-0478-01. 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 is selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1) 1.1 Attention-Deficit/Hyperactivity Disorder (ADHD) Atomoxetine is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). The efficacy of atomoxetine is 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 or inattentive symptoms that cause…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 079021
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 18 mg/1 | CapsuleOral | Strides Pharma Science Limited | 64380-473 |
| Atomoxetine | Atomoxetine hydrochloride 10 mg/1 | CapsuleOral | Strides Pharma Science Limited | 64380-472 |
| Atomoxetine | Atomoxetine hydrochloride 80 mg/1 | CapsuleOral | Strides Pharma Science Limited | 64380-477 |
| Atomoxetine | Atomoxetine hydrochloride 25 mg/1 | CapsuleOral | Strides Pharma Science Limited | 64380-474 |
| Atomoxetine | Atomoxetine hydrochloride 40 mg/1 | CapsuleOral | Strides Pharma Science Limited | 64380-475 |
| Atomoxetine | Atomoxetine hydrochloride 60 mg/1 | CapsuleOral | Strides Pharma Science Limited | 64380-476 |
| Atomoxetine | Atomoxetine hydrochloride 10 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2541 |
| Atomoxetine | Atomoxetine hydrochloride 60 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2545 |
| Atomoxetine | Atomoxetine hydrochloride 18 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2542 |
| Atomoxetine | Atomoxetine hydrochloride 25 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2543 |
| Atomoxetine | Atomoxetine hydrochloride 40 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2544 |
| Atomoxetine | Atomoxetine hydrochloride 80 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2546 |
| Atomoxetine | Atomoxetine hydrochloride 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2547 |
| Atomoxetine | Atomoxetine hydrochloride 40 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-3033 |