NDC codes

FDA NDC Directory
Product NDC (as listed)64980-379Labeler and product segments. Claims need a package NDC.
Product NDC at billing width64980-0379Add 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
64980-379-03649800379036498003790330 CAPSULE in 1 BOTTLE (64980-379-03)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 — 100 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Rising Pharma Holdings, Inc.NDC labeler code 64980
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 079016
Marketing start
Listing expires
Other FDA classes
Norepinephrine Uptake Inhibitors (Mechanism)
Identifiers
Product ID 64980-379_64643df1-f14e-4f1d-a422-9d7efc2995e2SPL ID 64643df1-f14e-4f1d-a422-9d7efc2995e2SPL set ID 1cceab35-dc4a-40bc-a245-10b64820e217RxCUI 349591, 349592, 349593, 349594, 349595, 608139, 608143UNII 57WVB6I2W0UPC 0364980374033, 0364980373036, 0364980379038, 0364980378031, 0364980375030, 0364980377034, 0364980376037
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

N464980037903 followed by a unit qualifier and the quantity

Package 64980-0379-03. 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 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 64980-379

What is NDC 64980-379?
64980-379 is the product NDC for Atomoxetine, Atomoxetine hydrochloride 100 mg/1 capsule, listed with the FDA by Rising Pharma Holdings, Inc.. 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?
Rising Pharma Holdings, Inc., NDC labeler code 64980. 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 079016

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

FDA NDC Directory listings under ANDA 079016
ProductStrengthForm · routeLabelerProduct NDC
AtomoxetineAtomoxetine hydrochloride 60 mg/1CapsuleOralA-S Medication Solutions50090-6444
AtomoxetineAtomoxetine hydrochloride 40 mg/1CapsuleOralA-S Medication Solutions50090-6513
AtomoxetineAtomoxetine hydrochloride 25 mg/1CapsuleOralA-S Medication Solutions50090-6703
AtomoxetineAtomoxetine hydrochloride 40 mg/1CapsuleOralAmerican Health Packaging60687-326
AtomoxetineAtomoxetine hydrochloride 25 mg/1CapsuleOralAmerican Health Packaging60687-567
AtomoxetineAtomoxetine hydrochloride 10 mg/1CapsuleOralRising Pharma Holdings, Inc.64980-373
AtomoxetineAtomoxetine hydrochloride 18 mg/1CapsuleOralRising Pharma Holdings, Inc.64980-374
AtomoxetineAtomoxetine hydrochloride 25 mg/1CapsuleOralRising Pharma Holdings, Inc.64980-375
AtomoxetineAtomoxetine hydrochloride 40 mg/1CapsuleOralRising Pharma Holdings, Inc.64980-376
AtomoxetineAtomoxetine hydrochloride 60 mg/1CapsuleOralRising Pharma Holdings, Inc.64980-377
AtomoxetineAtomoxetine hydrochloride 80 mg/1CapsuleOralRising Pharma Holdings, Inc.64980-378
AtomoxetineAtomoxetine hydrochloride 18 mg/1CapsuleOralAurobindo Pharma Limited65862-239
AtomoxetineAtomoxetine hydrochloride 25 mg/1CapsuleOralAurobindo Pharma Limited65862-240
AtomoxetineAtomoxetine hydrochloride 40 mg/1CapsuleOralAurobindo Pharma Limited65862-241
AtomoxetineAtomoxetine hydrochloride 80 mg/1CapsuleOralAurobindo Pharma Limited65862-243
AtomoxetineAtomoxetine hydrochloride 40 mg/1CapsuleOralBryant Ranch Prepack71335-2162
AtomoxetineAtomoxetine hydrochloride 60 mg/1CapsuleOralBryant Ranch Prepack71335-9702

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in