Intuniv (guanfacine) NDC 54092-515

NDC codes

FDA NDC Directory

Product NDC (as listed)54092-515Labeler and product segments. Claims need a package NDC.

Product NDC at billing width54092-0515Add 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
54092-515-02	54092051502	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (54092-515-02)Marketed from Sep 2, 2009

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): Intuniv
Generic name (nonproprietary): guanfacine
Active ingredients: Guanfacine hydrochloride — 2 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Takeda Pharmaceuticals America, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022037
Marketing start: Sep 2, 2009
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha2-Agonists (Mechanism)
Identifiers: Product ID 54092-515_448b4d80-7441-4a2f-839f-c61052d6e83aSPL ID 448b4d80-7441-4a2f-839f-c61052d6e83aSPL set ID b972af81-3a37-40be-9fe1-3ddf59852528RxCUI 862006, 862010, 862013, 862015, 862019, 862021, 862025, 862027, 1092566, 1092567UNII PML56A160OUPC 0354092513024, 0354092519026, 0354092515028, 0354092517022
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

N454092051502 followed by a unit qualifier and the quantity

Package 54092-0515-02. 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 Jun 23, 2025.

Indications (excerpt from the label)

INTUNIV ® is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications [see Clinical Studies (14) ]. INTUNIV 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 NDA 022037

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

FDA NDC Directory listings under NDA 022037
Product	Strength	Form · route	Labeler	Product NDC
Intunivguanfacine	Guanfacine hydrochloride 1 mg/1	Tablet, Extended releaseOral	Takeda Pharmaceuticals America, Inc.	54092-513
Intunivguanfacine	Guanfacine hydrochloride 3 mg/1	Tablet, Extended releaseOral	Takeda Pharmaceuticals America, Inc.	54092-517
Intunivguanfacine	Guanfacine hydrochloride 4 mg/1	Tablet, Extended releaseOral	Takeda Pharmaceuticals America, Inc.	54092-519