Prescription drug · ANDA

Atomoxetine NDC 50090-6143

Atomoxetine hydrochloride 40 mg/1 · Capsule · Oral · A-S Medication Solutions

NDC codes

FDA NDC Directory
Product NDC (as listed)50090-6143Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-6143Add 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
50090-6143-0500906143005009061430030 CAPSULE in 1 BOTTLE (50090-6143-0)Marketed from Oct 4, 2022

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
Generic name (nonproprietary)
atomoxetine
Active ingredients
Atomoxetine hydrochloride — 40 mg/1
Dosage form
Capsule
Route
Oral
Labeler
A-S Medication SolutionsNDC labeler code 50090
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202682
Marketing start
Listing expires
Other FDA classes
Norepinephrine Uptake Inhibitors (Mechanism)
Identifiers
Product ID 50090-6143_a726ffd7-e7bd-4005-8b8a-b4d9bb58b67fSPL ID a726ffd7-e7bd-4005-8b8a-b4d9bb58b67fSPL set ID 0782204e-56a3-4439-9fb8-194da9487049RxCUI 349594UNII 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

N450090614300 followed by a unit qualifier and the quantity

Package 50090-6143-00. 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 capsule 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 capsule is 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-impulsive or…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50090-6143

What is NDC 50090-6143?
50090-6143 is the product NDC for Atomoxetine, Atomoxetine hydrochloride 40 mg/1 capsule, listed with the FDA by A-S Medication Solutions. 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?
A-S Medication Solutions, NDC labeler code 50090. 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 202682

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

FDA NDC Directory listings under ANDA 202682
ProductStrengthForm · routeLabelerProduct NDC
AtomoxetineAtomoxetine hydrochloride 60 mg/1CapsuleOralNorthStar RxLLC72603-439
AtomoxetineAtomoxetine hydrochloride 80 mg/1CapsuleOralNorthStar RxLLC72603-440
AtomoxetineAtomoxetine hydrochloride 100 mg/1CapsuleOralNorthStar RxLLC72603-441
AtomoxetineAtomoxetine hydrochloride 80 mg/1CapsuleOralA-S Medication Solutions50090-6127
AtomoxetineAtomoxetine hydrochloride 100 mg/1CapsuleOralA-S Medication Solutions50090-6144
AtomoxetineAtomoxetine hydrochloride 10 mg/1CapsuleOralCamber Pharmaceuticals, Inc.31722-714
AtomoxetineAtomoxetine hydrochloride 60 mg/1CapsuleOralCamber Pharmaceuticals, Inc.31722-718
AtomoxetineAtomoxetine hydrochloride 18 mg/1CapsuleOralCamber Pharmaceuticals, Inc.31722-715
AtomoxetineAtomoxetine hydrochloride 25 mg/1CapsuleOralCamber Pharmaceuticals, Inc.31722-716
AtomoxetineAtomoxetine hydrochloride 40 mg/1CapsuleOralCamber Pharmaceuticals, Inc.31722-717
AtomoxetineAtomoxetine hydrochloride 80 mg/1CapsuleOralCamber Pharmaceuticals, Inc.31722-719
AtomoxetineAtomoxetine hydrochloride 100 mg/1CapsuleOralCamber Pharmaceuticals, Inc.31722-720
AtomoxetineAtomoxetine hydrochloride 40 mg/1CapsuleOralNorthStar RxLLC72603-438
AtomoxetineAtomoxetine hydrochloride 10 mg/1CapsuleOralNorthStar RxLLC72603-435
AtomoxetineAtomoxetine hydrochloride 18 mg/1CapsuleOralNorthStar RxLLC72603-436
AtomoxetineAtomoxetine hydrochloride 25 mg/1CapsuleOralNorthStar RxLLC72603-437

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