Prescription drug · ANDA
Atomoxetine NDC 31722-719
Atomoxetine hydrochloride 80 mg/1 · Capsule · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-719-30 | 31722071930 | 30 CAPSULE in 1 BOTTLE (31722-719-30)Marketed from Mar 11, 2021 |
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 — 80 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202682
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 31722-719_52a3d33b-4b01-9de5-e063-6294a90ae28dSPL ID 52a3d33b-4b01-9de5-e063-6294a90ae28dSPL set ID f266ab7b-5a68-42b5-b204-e3249bea0aedRxCUI 349591, 349592, 349593, 349594, 349595, 608139, 608143UNII 57WVB6I2W0UPC 0331722719308, 0331722715300, 0331722717304, 0331722718301, 0331722716307, 0331722720304, 0331722714303
- 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
N431722071930followed by a unit qualifier and the quantityPackage 31722-0719-30. 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 capsule is 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 capsule is 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 or…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202682
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 | Camber Pharmaceuticals, Inc. | 31722-715 |
| Atomoxetine | Atomoxetine hydrochloride 10 mg/1 | CapsuleOral | Camber Pharmaceuticals, Inc. | 31722-714 |
| Atomoxetine | Atomoxetine hydrochloride 25 mg/1 | CapsuleOral | Camber Pharmaceuticals, Inc. | 31722-716 |
| Atomoxetine | Atomoxetine hydrochloride 40 mg/1 | CapsuleOral | Camber Pharmaceuticals, Inc. | 31722-717 |
| Atomoxetine | Atomoxetine hydrochloride 60 mg/1 | CapsuleOral | Camber Pharmaceuticals, Inc. | 31722-718 |
| Atomoxetine | Atomoxetine hydrochloride 100 mg/1 | CapsuleOral | Camber Pharmaceuticals, Inc. | 31722-720 |
| Atomoxetine | Atomoxetine hydrochloride 10 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-435 |
| Atomoxetine | Atomoxetine hydrochloride 18 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-436 |
| Atomoxetine | Atomoxetine hydrochloride 80 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6127 |
| Atomoxetine | Atomoxetine hydrochloride 60 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-439 |
| Atomoxetine | Atomoxetine hydrochloride 25 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-437 |
| Atomoxetine | Atomoxetine hydrochloride 40 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-438 |
| Atomoxetine | Atomoxetine hydrochloride 80 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-440 |
| Atomoxetine | Atomoxetine hydrochloride 100 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-441 |
| Atomoxetine | Atomoxetine hydrochloride 40 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6143 |
| Atomoxetine | Atomoxetine hydrochloride 100 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6144 |