Prescription drug · ANDA
Atomoxetine NDC 55111-519
Atomoxetine hydrochloride 10 mg/1 · Capsule · Oral · Dr. Reddy's Laboratories Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55111-519-05 | 55111051905 | 500 CAPSULE in 1 BOTTLE (55111-519-05)Marketed from Feb 23, 2018 | |
| 55111-519-30 | 55111051930 | 30 CAPSULE in 1 BOTTLE (55111-519-30)Marketed from Feb 23, 2018 | |
| 55111-519-78 | 55111051978 | 100 BLISTER PACK in 1 CARTON (55111-519-78) / 10 CAPSULE in 1 BLISTER PACK (55111-519-79)Marketed from Feb 23, 2018 |
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 — 10 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090609
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 55111-519_d266ad8b-af60-8e42-149b-e881323543a5SPL ID d266ad8b-af60-8e42-149b-e881323543a5SPL set ID 973bdc9b-6421-7e00-e2b6-3cce036d363eRxCUI 349591, 349592, 349593, 349594, 349595, 608139, 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
N455111051905followed by a unit qualifier and the quantityPackage 55111-0519-05. 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 hydrochloride 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 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-impulsi…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090609
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 40 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-6908 |
| Atomoxetine | Atomoxetine hydrochloride 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4337 |
| Atomoxetine | Atomoxetine hydrochloride 18 mg/1 | CapsuleOral | Dr. Reddy's Laboratories Limited | 55111-520 |
| Atomoxetine | Atomoxetine hydrochloride 40 mg/1 | CapsuleOral | Dr. Reddy's Laboratories Limited | 55111-521 |
| Atomoxetine | Atomoxetine hydrochloride 60 mg/1 | CapsuleOral | Dr. Reddy's Laboratories Limited | 55111-522 |
| Atomoxetine | Atomoxetine hydrochloride 25 mg/1 | CapsuleOral | Dr. Reddy's Laboratories Limited | 55111-528 |
| Atomoxetine | Atomoxetine hydrochloride 100 mg/1 | CapsuleOral | Dr. Reddy's Laboratories Limited | 55111-564 |
| Atomoxetine | Atomoxetine hydrochloride 80 mg/1 | CapsuleOral | Dr. Reddy's Laboratories Limited | 55111-563 |
| Atomoxetine | Atomoxetine hydrochloride 40 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-9427 |
| Atomoxetine | Atomoxetine hydrochloride 60 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-9428 |