Prescription drug · ANDA

atomoxetine NDC 16714-758

Atomoxetine hydrochloride 40 mg/1 · Capsule · Oral · Northstar Rx LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)16714-758Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16714-0758Add 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
16714-758-01167140758011671407580130 CAPSULE in 1 BOTTLE (16714-758-01)Marketed from Jun 1, 2018

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 — 40 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Northstar Rx LLCNDC labeler code 16714
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 16714-758_a0f55e56-0899-430c-b25d-475d713f3a93SPL ID a0f55e56-0899-430c-b25d-475d713f3a93SPL set ID 133a4b65-762b-4712-baba-2442546f0379RxCUI 349591, 349592, 349593, 349594, 349595, 608139, 608143UNII 57WVB6I2W0UPC 0316714760018, 0316714755014, 0316714756011, 0316714761015, 0316714757018
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

N416714075801 followed by a unit qualifier and the quantity

Package 16714-0758-01. 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 capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. Atomoxetine capsules is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD Atomoxetine capsules are selective norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of ADHD in adults and pediatric patients 6 years of age and older. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16714-758

What is NDC 16714-758?
16714-758 is the product NDC for atomoxetine, Atomoxetine hydrochloride 40 mg/1 capsule, listed with the FDA by Northstar Rx LLC. 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?
Northstar Rx LLC, NDC labeler code 16714. 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 18 mg/1CapsuleOralGlenmark Pharmaceuticals Inc., USA68462-266
atomoxetineAtomoxetine hydrochloride 60 mg/1CapsuleOralNorthstar Rx LLC16714-759
atomoxetineAtomoxetine hydrochloride 100 mg/1CapsuleOralGlenmark Pharmaceuticals Inc., USA68462-271
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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