Prescription drug · ANDA

Atomoxetine NDC 64380-477

Atomoxetine hydrochloride 80 mg/1 · Capsule · Oral · Strides Pharma Science Limited

NDC codes

FDA NDC Directory
Product NDC (as listed)64380-477Labeler and product segments. Claims need a package NDC.
Product NDC at billing width64380-0477Add 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
64380-477-01643800477016438004770130 CAPSULE in 1 BOTTLE, PLASTIC (64380-477-01)Marketed from Jul 1, 2025
64380-477-056438004770564380047705500 CAPSULE in 1 BOTTLE, PLASTIC (64380-477-05)Marketed from Jul 1, 2025

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 — 80 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Strides Pharma Science LimitedNDC labeler code 64380
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 079021
Marketing start
Listing expires
Other FDA classes
Norepinephrine Uptake Inhibitors (Mechanism)
Identifiers
Product ID 64380-477_94ef88bd-e176-4c16-9340-ae0168422053SPL ID 94ef88bd-e176-4c16-9340-ae0168422053SPL set ID 2614df7e-0b16-4b03-883e-141d4ec34b35RxCUI 349591, 349592, 349593, 349594, 349595, 608139, 608143UNII 57WVB6I2W0UPC 0364380475019, 0364380478010, 0364380476016, 0364380477013
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

N464380047701 followed by a unit qualifier and the quantity

Package 64380-0477-01. 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 selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1) 1.1 Attention-Deficit/Hyperactivity Disorder (ADHD) Atomoxetine is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). The efficacy of atomoxetine is 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 inattentive symptoms that cause…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 64380-477

What is NDC 64380-477?
64380-477 is the product NDC for Atomoxetine, Atomoxetine hydrochloride 80 mg/1 capsule, listed with the FDA by Strides Pharma Science Limited. It has 2 package NDCs, 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?
Strides Pharma Science Limited, NDC labeler code 64380. 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 079021

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

FDA NDC Directory listings under ANDA 079021
ProductStrengthForm · routeLabelerProduct NDC
AtomoxetineAtomoxetine hydrochloride 80 mg/1CapsuleOralBryant Ranch Prepack72162-2546
AtomoxetineAtomoxetine hydrochloride 100 mg/1CapsuleOralBryant Ranch Prepack72162-2547
AtomoxetineAtomoxetine hydrochloride 10 mg/1CapsuleOralBryant Ranch Prepack72162-2541
AtomoxetineAtomoxetine hydrochloride 18 mg/1CapsuleOralBryant Ranch Prepack72162-2542
AtomoxetineAtomoxetine hydrochloride 25 mg/1CapsuleOralBryant Ranch Prepack72162-2543
AtomoxetineAtomoxetine hydrochloride 40 mg/1CapsuleOralBryant Ranch Prepack72162-2544
AtomoxetineAtomoxetine hydrochloride 60 mg/1CapsuleOralBryant Ranch Prepack72162-2545
AtomoxetineAtomoxetine hydrochloride 10 mg/1CapsuleOralStrides Pharma Science Limited64380-472
AtomoxetineAtomoxetine hydrochloride 18 mg/1CapsuleOralStrides Pharma Science Limited64380-473
AtomoxetineAtomoxetine hydrochloride 25 mg/1CapsuleOralStrides Pharma Science Limited64380-474
AtomoxetineAtomoxetine hydrochloride 40 mg/1CapsuleOralStrides Pharma Science Limited64380-475
AtomoxetineAtomoxetine hydrochloride 60 mg/1CapsuleOralStrides Pharma Science Limited64380-476
AtomoxetineAtomoxetine hydrochloride 100 mg/1CapsuleOralStrides Pharma Science Limited64380-478
AtomoxetineAtomoxetine hydrochloride 40 mg/1CapsuleOralBryant Ranch Prepack71335-3033

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