Prescription drug · ANDA

atomoxetine NDC 68462-271

Atomoxetine hydrochloride 100 mg/1 · Capsule · Oral · Glenmark Pharmaceuticals Inc., USA

NDC codes

FDA NDC Directory
Product NDC (as listed)68462-271Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68462-0271Add 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
68462-271-30684620271306846202713030 CAPSULE in 1 BOTTLE (68462-271-30)Marketed from May 30, 2017
68462-271-5168462027151684620271511500 CAPSULE in 1 BOTTLE (68462-271-51)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
Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 079019
Marketing start
Listing expires
Other FDA classes
Norepinephrine Uptake Inhibitors (Mechanism)
Identifiers
Product ID 68462-271_fd4eecf4-6fe9-4af5-9aa6-0affa7bd5be7SPL ID fd4eecf4-6fe9-4af5-9aa6-0affa7bd5be7
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

N468462027130 followed by a unit qualifier and the quantity

Package 68462-0271-30. 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 68462-271

What is NDC 68462-271?
68462-271 is the product NDC for atomoxetine, Atomoxetine hydrochloride 100 mg/1 capsule, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. 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?
Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. 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 079019

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

FDA NDC Directory listings under ANDA 079019
ProductStrengthForm · routeLabelerProduct NDC
atomoxetineAtomoxetine hydrochloride 60 mg/1CapsuleOralA-S Medication Solutions50090-7397
atomoxetineAtomoxetine hydrochloride 40 mg/1CapsuleOralA-S Medication Solutions50090-7462
atomoxetineAtomoxetine hydrochloride 100 mg/1CapsuleOralA-S Medication Solutions50090-7463
atomoxetineAtomoxetine hydrochloride 60 mg/1CapsuleOralBryant Ranch Prepack71335-2361
atomoxetineAtomoxetine hydrochloride 18 mg/1CapsuleOralNorthstar Rx LLC16714-756
atomoxetineAtomoxetine hydrochloride 10 mg/1CapsuleOralNorthstar Rx LLC16714-755
atomoxetineAtomoxetine hydrochloride 80 mg/1CapsuleOralNorthstar Rx LLC16714-760
atomoxetineAtomoxetine hydrochloride 25 mg/1CapsuleOralGlenmark Pharmaceuticals Inc., USA68462-267
atomoxetineAtomoxetine hydrochloride 25 mg/1CapsuleOralNorthstar Rx LLC16714-757
atomoxetineAtomoxetine hydrochloride 10 mg/1CapsuleOralGlenmark Pharmaceuticals Inc., USA68462-265
atomoxetineAtomoxetine hydrochloride 40 mg/1CapsuleOralNorthstar Rx LLC16714-758
atomoxetineAtomoxetine hydrochloride 18 mg/1CapsuleOralGlenmark Pharmaceuticals Inc., USA68462-266
atomoxetineAtomoxetine hydrochloride 60 mg/1CapsuleOralNorthstar Rx LLC16714-759
atomoxetineAtomoxetine hydrochloride 100 mg/1CapsuleOralNorthstar Rx LLC16714-761
atomoxetineAtomoxetine hydrochloride 40 mg/1CapsuleOralGlenmark Pharmaceuticals Inc., USA68462-268
atomoxetineAtomoxetine hydrochloride 60 mg/1CapsuleOralGlenmark Pharmaceuticals Inc., USA68462-269
atomoxetineAtomoxetine hydrochloride 80 mg/1CapsuleOralGlenmark Pharmaceuticals Inc., USA68462-270
atomoxetineAtomoxetine hydrochloride 25 mg/1CapsuleOralA-S Medication Solutions50090-7342

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