Prescription drug · ANDA
Atomoxetine NDC 82619-118
Atomoxetine hydrochloride 40 mg/1 · Capsule · Oral · Creekwood Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82619-118-01 | 82619011801 | 30 CAPSULE in 1 BOTTLE (82619-118-01)Marketed from Jul 6, 2026 | |
| 82619-118-02 | 82619011802 | 500 CAPSULE in 1 BOTTLE (82619-118-02)Marketed from Jul 6, 2026 |
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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218875
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 82619-118_587648dc-7a8b-43a9-e063-6294a90a620bSPL ID 587648dc-7a8b-43a9-e063-6294a90a620bSPL set ID 9b757805-eabf-4301-85be-7a3e38f6b187RxCUI 349591, 349592, 349593, 349594, 349595, 608139, 608143UNII 57WVB6I2W0UPC 0382619119015, 0382619120011, 0382619118018, 0382619121018
- 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
N482619011801followed by a unit qualifier and the quantityPackage 82619-0118-01. 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 capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. Atomoxetine capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD. Atomoxetine capsules are a selective norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of ADHD in adults and pediatric patients 6 years of age and older. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 218875
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 60 mg/1 | CapsuleOral | Creekwood Pharmaceuticals LLC | 82619-119 |
| Atomoxetine | Atomoxetine hydrochloride 25 mg/1 | CapsuleOral | Creekwood Pharmaceuticals LLC | 82619-117 |
| Atomoxetine | Atomoxetine hydrochloride 80 mg/1 | CapsuleOral | Creekwood Pharmaceuticals LLC | 82619-120 |
| Atomoxetine | Atomoxetine hydrochloride 100 mg/1 | CapsuleOral | Creekwood Pharmaceuticals LLC | 82619-121 |
| Atomoxetine | Atomoxetine hydrochloride 18 mg/1 | CapsuleOral | Creekwood Pharmaceuticals LLC | 82619-116 |
| Atomoxetine | Atomoxetine hydrochloride 10 mg/1 | CapsuleOral | Creekwood Pharmaceuticals LLC | 82619-115 |