Prescription drug · ANDA

Atomoxetine Hydrochloride NDC 50268-057

Atomoxetine hydrochloride 25 mg/1 · Capsule · Oral · AvPAK

NDC codes

FDA NDC Directory
Product NDC (as listed)50268-057Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50268-0057Add 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
50268-057-135026800571330 BLISTER PACK in 1 BOX (50268-057-13) / 1 CAPSULE in 1 BLISTER PACK (50268-057-11)Marketed from Feb 13, 2020

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 Hydrochloride
Generic name (nonproprietary)
atomoxetine hydrochloride
Active ingredients
Atomoxetine hydrochloride — 25 mg/1
Dosage form
Capsule
Route
Oral
Labeler
AvPAK
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 50268-057_47e225fb-3d2a-4f80-e063-6394a90aff85SPL ID 47e225fb-3d2a-4f80-e063-6394a90aff85SPL set ID 9e787cc2-5d0f-f231-e053-2a95a90ae99aRxCUI 349593, 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

N450268005713 followed by a unit qualifier and the quantity

Package 50268-0057-13. 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 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 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-impulsive or inat…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078983

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

FDA NDC Directory listings under ANDA 078983
ProductStrengthForm · routeLabelerProduct NDC
Atomoxetine HydrochlorideAtomoxetine hydrochloride 40 mg/1CapsuleOralA-S Medication Solutions50090-4236
Atomoxetine HydrochlorideAtomoxetine hydrochloride 25 mg/1CapsuleOralApotex Corp.60505-2832
Atomoxetine HydrochlorideAtomoxetine hydrochloride 10 mg/1CapsuleOralApotex Corp.60505-2830
Atomoxetine HydrochlorideAtomoxetine hydrochloride 18 mg/1CapsuleOralApotex Corp.60505-2831
Atomoxetine HydrochlorideAtomoxetine hydrochloride 80 mg/1CapsuleOralApotex Corp.60505-2835
Atomoxetine HydrochlorideAtomoxetine hydrochloride 40 mg/1CapsuleOralApotex Corp.60505-2833
Atomoxetine HydrochlorideAtomoxetine hydrochloride 60 mg/1CapsuleOralApotex Corp.60505-2834
Atomoxetine HydrochlorideAtomoxetine hydrochloride 100 mg/1CapsuleOralApotex Corp.60505-2836
Atomoxetine HydrochlorideAtomoxetine hydrochloride 40 mg/1CapsuleOralGolden State Medical Supply, Inc.51407-103
Atomoxetine HydrochlorideAtomoxetine hydrochloride 10 mg/1CapsuleOralGolden State Medical Supply, Inc.51407-100
Atomoxetine HydrochlorideAtomoxetine hydrochloride 18 mg/1CapsuleOralGolden State Medical Supply, Inc.51407-101
Atomoxetine HydrochlorideAtomoxetine hydrochloride 25 mg/1CapsuleOralGolden State Medical Supply, Inc.51407-102
Atomoxetine HydrochlorideAtomoxetine hydrochloride 100 mg/1CapsuleOralGolden State Medical Supply, Inc.51407-106
Atomoxetine HydrochlorideAtomoxetine hydrochloride 60 mg/1CapsuleOralGolden State Medical Supply, Inc.51407-104
Atomoxetine HydrochlorideAtomoxetine hydrochloride 80 mg/1CapsuleOralGolden State Medical Supply, Inc.51407-105
Atomoxetine HydrochlorideAtomoxetine hydrochloride 40 mg/1CapsuleOralAvPAK50268-058
Atomoxetine HydrochlorideAtomoxetine hydrochloride 60 mg/1CapsuleOralAvPAK50268-059
Atomoxetine HydrochlorideAtomoxetine hydrochloride 10 mg/1CapsuleOralREMEDYREPACK INC.70518-4313

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Atomoxetine Hydrochloride NDC 50268-057 | Med-Code