atomoxetine NDC 68382-218

NDC codes

FDA NDC Directory

Product NDC (as listed)68382-218Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68382-0218Add 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 NDC	11-digit (billing)	Package
68382-218-02	68382021802	2000 CAPSULE in 1 BOTTLE (68382-218-02)Marketed from Jun 12, 2017
68382-218-06	68382021806	30 CAPSULE in 1 BOTTLE (68382-218-06)Marketed from Jun 12, 2017
68382-218-10	68382021810	1000 CAPSULE in 1 BOTTLE (68382-218-10)Marketed from Jun 12, 2017
68382-218-14	68382021814	60 CAPSULE in 1 BOTTLE (68382-218-14)Marketed from Jun 12, 2017
68382-218-16	68382021816	90 CAPSULE in 1 BOTTLE (68382-218-16)Marketed from Jun 12, 2017
68382-218-77	68382021877	10 BLISTER PACK in 1 CARTON (68382-218-77) / 10 CAPSULE in 1 BLISTER PACK (68382-218-30)Marketed from Jun 12, 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 — 40 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Zydus Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 079017
Marketing start: Jun 12, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Norepinephrine Uptake Inhibitors (Mechanism)
Identifiers: Product ID 68382-218_8e543a65-7611-4362-94ba-0b3f929c776cSPL ID 8e543a65-7611-4362-94ba-0b3f929c776cSPL set ID 5f89c7c9-4c25-4ba2-ad90-5aeadb48f214RxCUI 349591, 349592, 349593, 349594, 349595, 608139, 608143UNII 57WVB6I2W0UPC 0368382215161
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

N468382021802 followed by a unit qualifier and the quantity

Package 68382-0218-02. 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 Mar 21, 2025. 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)