guanfacine NDC 0228-2855

NDC codes

FDA NDC Directory

Product NDC (as listed)0228-2855Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00228-2855Add 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
0228-2855-11	00228285511	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0228-2855-11)Marketed from Dec 1, 2014

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): guanfacine
Generic name (nonproprietary): guanfacine
Active ingredients: Guanfacine hydrochloride — 4 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 200881
Marketing start: Dec 1, 2014
Marketing end: Nov 30, 2026
Other FDA classes: Adrenergic alpha2-Agonists (Mechanism)
Identifiers: Product ID 0228-2855_00143252-2b74-4b11-86ed-9b864635f129SPL ID 00143252-2b74-4b11-86ed-9b864635f129SPL set ID 3a171942-37af-430d-8b9d-bb678ca2be4bRxCUI 862006, 862013, 862019, 862025UNII PML56A160OUPC 0302282853115, 0302282851111, 0302282850114
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

N400228285511 followed by a unit qualifier and the quantity

Package 00228-2855-11. 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 31, 2020.

Indications (excerpt from the label)

Guanfacine 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 )] . Guanfacine extended-release is a central alpha 2A -adrenergic receptor agonist indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications ( 1 , 14 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 200881

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

FDA NDC Directory listings under ANDA 200881
Product	Strength	Form · route	Labeler	Product NDC
guanfacine	Guanfacine hydrochloride 1 mg/1	Tablet, Extended releaseOral	Actavis Pharma, Inc.	0228-2850
guanfacine	Guanfacine hydrochloride 2 mg/1	Tablet, Extended releaseOral	Actavis Pharma, Inc.	0228-2851
guanfacine	Guanfacine hydrochloride 3 mg/1	Tablet, Extended releaseOral	Actavis Pharma, Inc.	0228-2853