Prescription drug · ANDA
Atomoxetine NDC 64980-376
Atomoxetine hydrochloride 40 mg/1 · Capsule · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64980-376-03 | 64980037603 | 30 CAPSULE in 1 BOTTLE (64980-376-03)Marketed from May 30, 2017 | |
| 64980-376-10 | 64980037610 | 1000 CAPSULE in 1 BOTTLE (64980-376-10)Marketed from May 30, 2017 |
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 — 40 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079016
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 64980-376_64643df1-f14e-4f1d-a422-9d7efc2995e2SPL ID 64643df1-f14e-4f1d-a422-9d7efc2995e2SPL set ID 1cceab35-dc4a-40bc-a245-10b64820e217RxCUI 349591, 349592, 349593, 349594, 349595, 608139, 608143UNII 57WVB6I2W0UPC 0364980374033, 0364980373036, 0364980379038, 0364980378031, 0364980375030, 0364980377034, 0364980376037
- 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
N464980037603followed by a unit qualifier and the quantityPackage 64980-0376-03. 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-impulsive …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 079016
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 | 50090-6703 |
| Atomoxetine | Atomoxetine hydrochloride 100 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-244 |
| Atomoxetine | Atomoxetine hydrochloride 40 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-241 |
| Atomoxetine | Atomoxetine hydrochloride 60 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-242 |
| Atomoxetine | Atomoxetine hydrochloride 80 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-243 |
| Atomoxetine | Atomoxetine hydrochloride 60 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6444 |
| Atomoxetine | Atomoxetine hydrochloride 40 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2162 |
| Atomoxetine | Atomoxetine hydrochloride 40 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6513 |
| Atomoxetine | Atomoxetine hydrochloride 25 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-240 |
| Atomoxetine | Atomoxetine hydrochloride 10 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-238 |
| Atomoxetine | Atomoxetine hydrochloride 25 mg/1 | CapsuleOral | American Health Packaging | 60687-567 |
| Atomoxetine | Atomoxetine hydrochloride 18 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-239 |
| Atomoxetine | Atomoxetine hydrochloride 40 mg/1 | CapsuleOral | American Health Packaging | 60687-326 |
| Atomoxetine | Atomoxetine hydrochloride 60 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-9702 |
| Atomoxetine | Atomoxetine hydrochloride 10 mg/1 | CapsuleOral | Rising Pharma Holdings, Inc. | 64980-373 |
| Atomoxetine | Atomoxetine hydrochloride 60 mg/1 | CapsuleOral | Rising Pharma Holdings, Inc. | 64980-377 |
| Atomoxetine | Atomoxetine hydrochloride 18 mg/1 | CapsuleOral | Rising Pharma Holdings, Inc. | 64980-374 |
| Atomoxetine | Atomoxetine hydrochloride 25 mg/1 | CapsuleOral | Rising Pharma Holdings, Inc. | 64980-375 |
| Atomoxetine | Atomoxetine hydrochloride 80 mg/1 | CapsuleOral | Rising Pharma Holdings, Inc. | 64980-378 |
| Atomoxetine | Atomoxetine hydrochloride 100 mg/1 | CapsuleOral | Rising Pharma Holdings, Inc. | 64980-379 |