Prescription drug · ANDA

Atomoxetine NDC 0093-3542

Atomoxetine hydrochloride 10 mg/1 · Capsule · Oral · Teva Pharmaceuticals USA, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)0093-3542Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00093-3542Add 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
0093-3542-56000933542560009335425630 CAPSULE in 1 BOTTLE (0093-3542-56)Marketed from May 30, 2017

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 — 10 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Teva Pharmaceuticals USA, Inc.NDC labeler code 0093
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 079022
Marketing start
Listing expires
Other FDA classes
Norepinephrine Uptake Inhibitors (Mechanism)
Identifiers
Product ID 0093-3542_8f789887-a198-4965-8582-e973d4da3994SPL ID 8f789887-a198-4965-8582-e973d4da3994
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

N400093354256 followed by a unit qualifier and the quantity

Package 00093-3542-56. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 0093-3542

What is NDC 0093-3542?
0093-3542 is the product NDC for Atomoxetine, Atomoxetine hydrochloride 10 mg/1 capsule, listed with the FDA by Teva Pharmaceuticals USA, 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?
Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. 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 079022

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

FDA NDC Directory listings under ANDA 079022
ProductStrengthForm · routeLabelerProduct NDC
AtomoxetineAtomoxetine hydrochloride 18 mg/1CapsuleOralTeva Pharmaceuticals USA, Inc.0093-3543
AtomoxetineAtomoxetine hydrochloride 25 mg/1CapsuleOralTeva Pharmaceuticals USA, Inc.0093-3544
AtomoxetineAtomoxetine hydrochloride 80 mg/1CapsuleOralA-S Medication Solutions50090-6511
AtomoxetineAtomoxetine hydrochloride 25 mg/1CapsuleOralA-S Medication Solutions50090-6512
AtomoxetineAtomoxetine hydrochloride 40 mg/1CapsuleOralTeva Pharmaceuticals USA, Inc.0093-3545
AtomoxetineAtomoxetine hydrochloride 60 mg/1CapsuleOralTeva Pharmaceuticals USA, Inc.0093-3546
AtomoxetineAtomoxetine hydrochloride 80 mg/1CapsuleOralTeva Pharmaceuticals USA, Inc.0093-3547
AtomoxetineAtomoxetine hydrochloride 100 mg/1CapsuleOralTeva Pharmaceuticals USA, Inc.0093-3548
AtomoxetineAtomoxetine hydrochloride 10 mg/1CapsuleOralAvKARE42291-064
AtomoxetineAtomoxetine hydrochloride 60 mg/1CapsuleOralA-S Medication Solutions50090-6254
AtomoxetineAtomoxetine hydrochloride 18 mg/1CapsuleOralAvKARE42291-065
AtomoxetineAtomoxetine hydrochloride 25 mg/1CapsuleOralAvKARE42291-066
AtomoxetineAtomoxetine hydrochloride 100 mg/1CapsuleOralAvKARE42291-070
AtomoxetineAtomoxetine hydrochloride 40 mg/1CapsuleOralAvKARE42291-067
AtomoxetineAtomoxetine hydrochloride 60 mg/1CapsuleOralAvKARE42291-068
AtomoxetineAtomoxetine hydrochloride 80 mg/1CapsuleOralAvKARE42291-069
AtomoxetineAtomoxetine hydrochloride 40 mg/1CapsuleOralA-S Medication Solutions50090-6289

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