Prescription drug · ANDA

atomoxetine NDC 68462-267

Atomoxetine hydrochloride 25 mg/1 · Capsule · Oral · Glenmark Pharmaceuticals Inc., USA

NDC codes

FDA NDC Directory
Product NDC (as listed)68462-267Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68462-0267Add 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
68462-267-23684620267232000 CAPSULE in 1 BOTTLE (68462-267-23)Marketed from May 30, 2017
68462-267-306846202673030 CAPSULE in 1 BOTTLE (68462-267-30)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 — 25 mg/1
Dosage form
Capsule
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 079019
Marketing start
Listing expires
Other FDA classes
Norepinephrine Uptake Inhibitors (Mechanism)
Identifiers
Product ID 68462-267_26737ed3-c979-48ee-b5b3-843939c09ff4SPL ID 26737ed3-c979-48ee-b5b3-843939c09ff4SPL set ID 0ab8d905-e890-4e91-a730-3e5d12f5c23fRxCUI 349591, 349592, 349593, 349594, 349595, 608139, 608143UNII 57WVB6I2W0UPC 0368462265307, 0368462270301, 0368462267301, 0368462271308, 0368462268308, 0368462269305, 0368462266304
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

N468462026723 followed by a unit qualifier and the quantity

Package 68462-0267-23. 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 is 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 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 079019

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

FDA NDC Directory listings under ANDA 079019
ProductStrengthForm · routeLabelerProduct NDC
atomoxetineAtomoxetine hydrochloride 25 mg/1CapsuleOralA-S Medication Solutions50090-7342
atomoxetineAtomoxetine hydrochloride 60 mg/1CapsuleOralBryant Ranch Prepack71335-2361
atomoxetineAtomoxetine hydrochloride 40 mg/1CapsuleOralNorthstar Rx LLC16714-758
atomoxetineAtomoxetine hydrochloride 10 mg/1CapsuleOralNorthstar Rx LLC16714-755
atomoxetineAtomoxetine hydrochloride 18 mg/1CapsuleOralNorthstar Rx LLC16714-756
atomoxetineAtomoxetine hydrochloride 25 mg/1CapsuleOralNorthstar Rx LLC16714-757
atomoxetineAtomoxetine hydrochloride 100 mg/1CapsuleOralNorthstar Rx LLC16714-761
atomoxetineAtomoxetine hydrochloride 60 mg/1CapsuleOralNorthstar Rx LLC16714-759
atomoxetineAtomoxetine hydrochloride 80 mg/1CapsuleOralNorthstar Rx LLC16714-760
atomoxetineAtomoxetine hydrochloride 60 mg/1CapsuleOralA-S Medication Solutions50090-7397
atomoxetineAtomoxetine hydrochloride 40 mg/1CapsuleOralA-S Medication Solutions50090-7462
atomoxetineAtomoxetine hydrochloride 100 mg/1CapsuleOralA-S Medication Solutions50090-7463
atomoxetineAtomoxetine hydrochloride 18 mg/1CapsuleOralGlenmark Pharmaceuticals Inc., USA68462-266
atomoxetineAtomoxetine hydrochloride 10 mg/1CapsuleOralGlenmark Pharmaceuticals Inc., USA68462-265
atomoxetineAtomoxetine hydrochloride 80 mg/1CapsuleOralGlenmark Pharmaceuticals Inc., USA68462-270
atomoxetineAtomoxetine hydrochloride 40 mg/1CapsuleOralGlenmark Pharmaceuticals Inc., USA68462-268
atomoxetineAtomoxetine hydrochloride 60 mg/1CapsuleOralGlenmark Pharmaceuticals Inc., USA68462-269
atomoxetineAtomoxetine hydrochloride 100 mg/1CapsuleOralGlenmark Pharmaceuticals Inc., USA68462-271

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atomoxetine NDC 68462-267 | Med-Code