Prescription drug · ANDA
Atomoxetine Hydrochloride NDC 60505-2835
Atomoxetine hydrochloride 80 mg/1 · Capsule · Oral · Apotex Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-2835-3 | 60505283503 | 30 CAPSULE in 1 BOTTLE (60505-2835-3)Marketed from May 21, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 Hydrochloride
- Generic name (nonproprietary)
- atomoxetine hydrochloride
- Active ingredients
- Atomoxetine hydrochloride — 80 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Apotex Corp.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078983
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 60505-2835_c668f0bc-71d1-fa44-32db-35fa6fc027a2SPL ID c668f0bc-71d1-fa44-32db-35fa6fc027a2SPL set ID 132852a6-5bff-15dd-255c-98309dd83630RxCUI 349591, 349592, 349593, 349594, 349595, 608139, 608143UNII 57WVB6I2W0UPC 0360505283132
- 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
N460505283503followed by a unit qualifier and the quantityPackage 60505-2835-03. 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 (SNRI) indicated for the treatment of ADHD in adults and pediatric patients 6 years of age and older. ( 1 ) 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.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078983
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 Hydrochloride | Atomoxetine hydrochloride 40 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-4236 |
| Atomoxetine Hydrochloride | Atomoxetine hydrochloride 25 mg/1 | CapsuleOral | Apotex Corp. | 60505-2832 |
| Atomoxetine Hydrochloride | Atomoxetine hydrochloride 10 mg/1 | CapsuleOral | Apotex Corp. | 60505-2830 |
| Atomoxetine Hydrochloride | Atomoxetine hydrochloride 18 mg/1 | CapsuleOral | Apotex Corp. | 60505-2831 |
| Atomoxetine Hydrochloride | Atomoxetine hydrochloride 40 mg/1 | CapsuleOral | Apotex Corp. | 60505-2833 |
| Atomoxetine Hydrochloride | Atomoxetine hydrochloride 60 mg/1 | CapsuleOral | Apotex Corp. | 60505-2834 |
| Atomoxetine Hydrochloride | Atomoxetine hydrochloride 100 mg/1 | CapsuleOral | Apotex Corp. | 60505-2836 |
| Atomoxetine Hydrochloride | Atomoxetine hydrochloride 40 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-103 |
| Atomoxetine Hydrochloride | Atomoxetine hydrochloride 10 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-100 |
| Atomoxetine Hydrochloride | Atomoxetine hydrochloride 18 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-101 |
| Atomoxetine Hydrochloride | Atomoxetine hydrochloride 25 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-102 |
| Atomoxetine Hydrochloride | Atomoxetine hydrochloride 100 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-106 |
| Atomoxetine Hydrochloride | Atomoxetine hydrochloride 60 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-104 |
| Atomoxetine Hydrochloride | Atomoxetine hydrochloride 80 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-105 |
| Atomoxetine Hydrochloride | Atomoxetine hydrochloride 25 mg/1 | CapsuleOral | AvPAK | 50268-057 |
| Atomoxetine Hydrochloride | Atomoxetine hydrochloride 40 mg/1 | CapsuleOral | AvPAK | 50268-058 |
| Atomoxetine Hydrochloride | Atomoxetine hydrochloride 60 mg/1 | CapsuleOral | AvPAK | 50268-059 |
| Atomoxetine Hydrochloride | Atomoxetine hydrochloride 10 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4313 |