What is NDC 55111-522?

55111-522 is the product NDC for Atomoxetine, Atomoxetine hydrochloride 60 mg/1 capsule, listed with the FDA by Dr. Reddy's Laboratories Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.

Dr. Reddy's Laboratories Limited, NDC labeler code 55111. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Atomoxetine NDC 55111-522 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)55111-522Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55111-0522Add 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 NDC	11-digit (billing)	Package
55111-522-05	5511105220555111052205	500 CAPSULE in 1 BOTTLE (55111-522-05)Marketed from Feb 23, 2018
55111-522-30	5511105223055111052230	30 CAPSULE in 1 BOTTLE (55111-522-30)Marketed from Feb 23, 2018
55111-522-78	5511105227855111052278	100 BLISTER PACK in 1 CARTON (55111-522-78) / 10 CAPSULE in 1 BLISTER PACK (55111-522-79)Marketed from Feb 23, 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 — 60 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Dr. Reddy's Laboratories LimitedNDC labeler code 55111
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090609
Marketing start: Feb 23, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Norepinephrine Uptake Inhibitors (Mechanism)
Identifiers: Product ID 55111-522_d266ad8b-af60-8e42-149b-e881323543a5SPL ID d266ad8b-af60-8e42-149b-e881323543a5SPL set ID 973bdc9b-6421-7e00-e2b6-3cce036d363eRxCUI 349591, 349592, 349593, 349594, 349595, 608139, 608143UNII 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

N455111052205 followed by a unit qualifier and the quantity

Package 55111-0522-05. 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 Jan 24, 2022. 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 55111-522

What is NDC 55111-522?: 55111-522 is the product NDC for Atomoxetine, Atomoxetine hydrochloride 60 mg/1 capsule, listed with the FDA by Dr. Reddy's Laboratories Limited. It has 3 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?: Dr. Reddy's Laboratories Limited, NDC labeler code 55111. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Atomoxetine	Atomoxetine hydrochloride 100 mg/1	CapsuleOral	Creekwood Pharmaceuticals LLC	82619-121	82619-0121-0182619-0121-02
Atomoxetine	Atomoxetine hydrochloride 60 mg/1	CapsuleOral	Creekwood Pharmaceuticals LLC	82619-119	82619-0119-0182619-0119-02
Atomoxetine	Atomoxetine hydrochloride 80 mg/1	CapsuleOral	Creekwood Pharmaceuticals LLC	82619-120	82619-0120-0182619-0120-02
Atomoxetine	Atomoxetine hydrochloride 40 mg/1	CapsuleOral	Creekwood Pharmaceuticals LLC	82619-118	82619-0118-0182619-0118-02
Atomoxetine	Atomoxetine hydrochloride 10 mg/1	CapsuleOral	Creekwood Pharmaceuticals LLC	82619-115	82619-0115-0182619-0115-02
Atomoxetine	Atomoxetine hydrochloride 18 mg/1	CapsuleOral	Creekwood Pharmaceuticals LLC	82619-116	82619-0116-0182619-0116-02
Atomoxetine	Atomoxetine hydrochloride 25 mg/1	CapsuleOral	Creekwood Pharmaceuticals LLC	82619-117	82619-0117-0182619-0117-02
Atomoxetine	Atomoxetine hydrochloride 25 mg/1	CapsuleOral	NorthStar RxLLC	72603-437	72603-0437-01
Atomoxetine	Atomoxetine hydrochloride 10 mg/1	CapsuleOral	NorthStar RxLLC	72603-435	72603-0435-01
Atomoxetine	Atomoxetine hydrochloride 18 mg/1	CapsuleOral	NorthStar RxLLC	72603-436	72603-0436-01

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
Product	Strength	Form · route	Labeler	Product NDC
Atomoxetine	Atomoxetine hydrochloride 40 mg/1	CapsuleOral	Major Pharmaceuticals	0904-6908
Atomoxetine	Atomoxetine hydrochloride 100 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4337
Atomoxetine	Atomoxetine hydrochloride 40 mg/1	CapsuleOral	Dr. Reddy's Laboratories Limited	55111-521
Atomoxetine	Atomoxetine hydrochloride 10 mg/1	CapsuleOral	Dr. Reddy's Laboratories Limited	55111-519
Atomoxetine	Atomoxetine hydrochloride 40 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-9427
Atomoxetine	Atomoxetine hydrochloride 18 mg/1	CapsuleOral	Dr. Reddy's Laboratories Limited	55111-520
Atomoxetine	Atomoxetine hydrochloride 60 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-9428
Atomoxetine	Atomoxetine hydrochloride 25 mg/1	CapsuleOral	Dr. Reddy's Laboratories Limited	55111-528
Atomoxetine	Atomoxetine hydrochloride 100 mg/1	CapsuleOral	Dr. Reddy's Laboratories Limited	55111-564
Atomoxetine	Atomoxetine hydrochloride 80 mg/1	CapsuleOral	Dr. Reddy's Laboratories Limited	55111-563