Prescription drug · ANDA

Atomoxetine NDC 42291-065

Atomoxetine hydrochloride 18 mg/1 · Capsule · Oral · AvKARE

NDC codes

FDA NDC Directory
Product NDC (as listed)42291-065Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42291-0065Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
42291-065-30422910065304229100653030 CAPSULE in 1 BOTTLE (42291-065-30)Marketed from Apr 12, 2022

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
AvKARENDC labeler code 42291
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 079022
Marketing start
Listing expires
Other FDA classes
Norepinephrine Uptake Inhibitors (Mechanism)
Identifiers
Product ID 42291-065_485b5018-57ec-90d7-e063-6294a90ae5e2SPL ID 485b5018-57ec-90d7-e063-6294a90ae5e2SPL set ID dc7ba02c-bdbb-5136-e053-2995a90ac545RxCUI 349591, 349592, 349593, 349594, 349595, 608139, 608143UNII 57WVB6I2W0UPC 0342291066304, 0342291069305, 0342291068308, 0342291064300, 0342291070301, 0342291067301
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

N442291006530 followed by a unit qualifier and the quantity

Package 42291-0065-30. 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 capsules are 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-impuls…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42291-065

What is NDC 42291-065?
42291-065 is the product NDC for Atomoxetine, Atomoxetine hydrochloride 18 mg/1 capsule, listed with the FDA by AvKARE. It has 1 package NDC, 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?
AvKARE, NDC labeler code 42291. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Atomoxetine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
AtomoxetineAtomoxetine hydrochloride 100 mg/1CapsuleOralCreekwood Pharmaceuticals LLC82619-12182619-0121-0182619-0121-02
AtomoxetineAtomoxetine hydrochloride 60 mg/1CapsuleOralCreekwood Pharmaceuticals LLC82619-11982619-0119-0182619-0119-02
AtomoxetineAtomoxetine hydrochloride 80 mg/1CapsuleOralCreekwood Pharmaceuticals LLC82619-12082619-0120-0182619-0120-02
AtomoxetineAtomoxetine hydrochloride 40 mg/1CapsuleOralCreekwood Pharmaceuticals LLC82619-11882619-0118-0182619-0118-02
AtomoxetineAtomoxetine hydrochloride 10 mg/1CapsuleOralCreekwood Pharmaceuticals LLC82619-11582619-0115-0182619-0115-02
AtomoxetineAtomoxetine hydrochloride 18 mg/1CapsuleOralCreekwood Pharmaceuticals LLC82619-11682619-0116-0182619-0116-02
AtomoxetineAtomoxetine hydrochloride 25 mg/1CapsuleOralCreekwood Pharmaceuticals LLC82619-11782619-0117-0182619-0117-02
AtomoxetineAtomoxetine hydrochloride 25 mg/1CapsuleOralNorthStar RxLLC72603-43772603-0437-01
AtomoxetineAtomoxetine hydrochloride 10 mg/1CapsuleOralNorthStar RxLLC72603-43572603-0435-01
AtomoxetineAtomoxetine hydrochloride 18 mg/1CapsuleOralNorthStar RxLLC72603-43672603-0436-01

All 109 Atomoxetine NDCs

Other NDCs under ANDA 079022

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 079022
ProductStrengthForm · routeLabelerProduct NDC
AtomoxetineAtomoxetine hydrochloride 10 mg/1CapsuleOralTeva Pharmaceuticals USA, Inc.0093-3542
AtomoxetineAtomoxetine hydrochloride 18 mg/1CapsuleOralTeva Pharmaceuticals USA, Inc.0093-3543
AtomoxetineAtomoxetine hydrochloride 25 mg/1CapsuleOralTeva Pharmaceuticals USA, Inc.0093-3544
AtomoxetineAtomoxetine hydrochloride 80 mg/1CapsuleOralA-S Medication Solutions50090-6511
AtomoxetineAtomoxetine hydrochloride 25 mg/1CapsuleOralA-S Medication Solutions50090-6512
AtomoxetineAtomoxetine hydrochloride 40 mg/1CapsuleOralTeva Pharmaceuticals USA, Inc.0093-3545
AtomoxetineAtomoxetine hydrochloride 60 mg/1CapsuleOralTeva Pharmaceuticals USA, Inc.0093-3546
AtomoxetineAtomoxetine hydrochloride 80 mg/1CapsuleOralTeva Pharmaceuticals USA, Inc.0093-3547
AtomoxetineAtomoxetine hydrochloride 100 mg/1CapsuleOralTeva Pharmaceuticals USA, Inc.0093-3548
AtomoxetineAtomoxetine hydrochloride 10 mg/1CapsuleOralAvKARE42291-064
AtomoxetineAtomoxetine hydrochloride 60 mg/1CapsuleOralA-S Medication Solutions50090-6254
AtomoxetineAtomoxetine hydrochloride 25 mg/1CapsuleOralAvKARE42291-066
AtomoxetineAtomoxetine hydrochloride 100 mg/1CapsuleOralAvKARE42291-070
AtomoxetineAtomoxetine hydrochloride 40 mg/1CapsuleOralAvKARE42291-067
AtomoxetineAtomoxetine hydrochloride 60 mg/1CapsuleOralAvKARE42291-068
AtomoxetineAtomoxetine hydrochloride 80 mg/1CapsuleOralAvKARE42291-069
AtomoxetineAtomoxetine hydrochloride 40 mg/1CapsuleOralA-S Medication Solutions50090-6289

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in