NDC codes

FDA NDC Directory
Product NDC (as listed)0904-6908Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00904-6908Add 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
0904-6908-04009046908040090469080430 BLISTER PACK in 1 CARTON (0904-6908-04) / 1 CAPSULE in 1 BLISTER PACKMarketed from Feb 23, 2018

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
Major PharmaceuticalsNDC labeler code 0904
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090609
Marketing start
Listing expires
Other FDA classes
Norepinephrine Uptake Inhibitors (Mechanism)
Identifiers
Product ID 0904-6908_e4c4122b-6772-46a0-aaaa-3815e6a9736fSPL ID e4c4122b-6772-46a0-aaaa-3815e6a9736fSPL set ID f98c3424-1c43-43e4-8bca-2e3430f50c63RxCUI 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

N400904690804 followed by a unit qualifier and the quantity

Package 00904-6908-04. 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 hydrochloride 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-impulsi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0904-6908

What is NDC 0904-6908?
0904-6908 is the product NDC for Atomoxetine, Atomoxetine hydrochloride 40 mg/1 capsule, listed with the FDA by Major Pharmaceuticals. 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?
Major Pharmaceuticals, NDC labeler code 0904. 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 090609

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

FDA NDC Directory listings under ANDA 090609
ProductStrengthForm · routeLabelerProduct NDC
AtomoxetineAtomoxetine hydrochloride 100 mg/1CapsuleOralREMEDYREPACK INC.70518-4337
AtomoxetineAtomoxetine hydrochloride 40 mg/1CapsuleOralDr. Reddy's Laboratories Limited55111-521
AtomoxetineAtomoxetine hydrochloride 10 mg/1CapsuleOralDr. Reddy's Laboratories Limited55111-519
AtomoxetineAtomoxetine hydrochloride 40 mg/1CapsuleOralBryant Ranch Prepack63629-9427
AtomoxetineAtomoxetine hydrochloride 18 mg/1CapsuleOralDr. Reddy's Laboratories Limited55111-520
AtomoxetineAtomoxetine hydrochloride 60 mg/1CapsuleOralBryant Ranch Prepack63629-9428
AtomoxetineAtomoxetine hydrochloride 60 mg/1CapsuleOralDr. Reddy's Laboratories Limited55111-522
AtomoxetineAtomoxetine hydrochloride 25 mg/1CapsuleOralDr. Reddy's Laboratories Limited55111-528
AtomoxetineAtomoxetine hydrochloride 100 mg/1CapsuleOralDr. Reddy's Laboratories Limited55111-564
AtomoxetineAtomoxetine hydrochloride 80 mg/1CapsuleOralDr. Reddy's Laboratories Limited55111-563

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