Prescription drug · ANDA
Atomoxetine NDC 65862-239
Atomoxetine hydrochloride 18 mg/1 · Capsule · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-239-22 | 6586202392265862023922 | 2000 CAPSULE in 1 BOTTLE (65862-239-22)Marketed from May 30, 2017 | |
| 65862-239-30 | 6586202393065862023930 | 30 CAPSULE in 1 BOTTLE (65862-239-30)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 — 18 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 65862
- 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 65862-239_22c52934-6506-4069-92ea-a150ee078741SPL ID 22c52934-6506-4069-92ea-a150ee078741SPL set ID 6f6bea0c-297b-43ff-8960-ecc11243e06eRxCUI 349591, 349592, 349593, 349594, 349595, 608139, 608143UNII 57WVB6I2W0UPC 0365862239303, 0365862238306, 0365862240309, 0365862242303, 0365862241306
- 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
N465862023922followed by a unit qualifier and the quantityPackage 65862-0239-22. 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.
About NDC 65862-239
- What is NDC 65862-239?
- 65862-239 is the product NDC for Atomoxetine, Atomoxetine hydrochloride 18 mg/1 capsule, listed with the FDA by Aurobindo Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Atomoxetine.
- What is the active ingredient?
- Atomoxetine hydrochloride.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Atomoxetine?
- 108 other product NDCs are listed under this name. See all Atomoxetine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Atomoxetine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Atomoxetine | Atomoxetine hydrochloride 100 mg/1 | CapsuleOral | Creekwood Pharmaceuticals LLC | 82619-121 | 82619-0121-0182619-0121-02 |
| Atomoxetine | Atomoxetine hydrochloride 60 mg/1 | CapsuleOral | Creekwood Pharmaceuticals LLC | 82619-119 | 82619-0119-0182619-0119-02 |
| Atomoxetine | Atomoxetine hydrochloride 80 mg/1 | CapsuleOral | Creekwood Pharmaceuticals LLC | 82619-120 | 82619-0120-0182619-0120-02 |
| Atomoxetine | Atomoxetine hydrochloride 40 mg/1 | CapsuleOral | Creekwood Pharmaceuticals LLC | 82619-118 | 82619-0118-0182619-0118-02 |
| Atomoxetine | Atomoxetine hydrochloride 10 mg/1 | CapsuleOral | Creekwood Pharmaceuticals LLC | 82619-115 | 82619-0115-0182619-0115-02 |
| Atomoxetine | Atomoxetine hydrochloride 18 mg/1 | CapsuleOral | Creekwood Pharmaceuticals LLC | 82619-116 | 82619-0116-0182619-0116-02 |
| Atomoxetine | Atomoxetine hydrochloride 25 mg/1 | CapsuleOral | Creekwood Pharmaceuticals LLC | 82619-117 | 82619-0117-0182619-0117-02 |
| Atomoxetine | Atomoxetine hydrochloride 25 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-437 | 72603-0437-01 |
| Atomoxetine | Atomoxetine hydrochloride 10 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-435 | 72603-0435-01 |
| Atomoxetine | Atomoxetine hydrochloride 18 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-436 | 72603-0436-01 |
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 60 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6444 |
| Atomoxetine | Atomoxetine hydrochloride 40 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6513 |
| Atomoxetine | Atomoxetine hydrochloride 25 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6703 |
| Atomoxetine | Atomoxetine hydrochloride 40 mg/1 | CapsuleOral | American Health Packaging | 60687-326 |
| Atomoxetine | Atomoxetine hydrochloride 25 mg/1 | CapsuleOral | American Health Packaging | 60687-567 |
| Atomoxetine | Atomoxetine hydrochloride 10 mg/1 | CapsuleOral | Rising Pharma Holdings, Inc. | 64980-373 |
| 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 40 mg/1 | CapsuleOral | Rising Pharma Holdings, Inc. | 64980-376 |
| Atomoxetine | Atomoxetine hydrochloride 60 mg/1 | CapsuleOral | Rising Pharma Holdings, Inc. | 64980-377 |
| 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 |
| Atomoxetine | Atomoxetine hydrochloride 25 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-240 |
| Atomoxetine | Atomoxetine hydrochloride 40 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-241 |
| Atomoxetine | Atomoxetine hydrochloride 80 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-243 |
| Atomoxetine | Atomoxetine hydrochloride 40 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2162 |
| Atomoxetine | Atomoxetine hydrochloride 60 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-9702 |