Clonidine Hydrochloride NDC 0228-4241

NDC codes

FDA NDC Directory

Product NDC (as listed)0228-4241Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00228-4241Add 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	Copy
0228-4241-06	00228424106	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0228-4241-06)Marketed from Jun 17, 2015

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): Clonidine Hydrochloride
Generic name (nonproprietary): clonidine hydrochloride
Active ingredients: Clonidine hydrochloride — .1 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Actavis Pharma, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203320
Marketing start: Jun 17, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha2-Agonists (Mechanism)
Identifiers: Product ID 0228-4241_5082cfd3-e748-4c4b-81ba-0957f02244a5SPL ID 5082cfd3-e748-4c4b-81ba-0957f02244a5SPL set ID 0100c70d-7fde-46a1-8374-940550a27e43RxCUI 1013930UNII W76I6XXF06
Pharmacologic class: Central alpha-2 Adrenergic Agonist

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

N400228424106 followed by a unit qualifier and the quantity

Package 00228-4241-06. 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 Oct 1, 2023.

Indications (excerpt from the label)

Clonidine hydrochloride extended-release tablets are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications [see Clinical Studies (14) ] . Clonidine hydrochloride extended-release tablets are a centrally acting alpha 2 -adrenergic agonist indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy to stimulant medications. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)