What is NDC 72189-469?

72189-469 is the product NDC for Guanfacine ER, Guanfacine hydrochloride 1 mg/1 tablet, extended release, listed with the FDA by Direct_Rx. It has 1 package NDC, shown above in 10- and 11-digit form.

Direct_Rx, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Guanfacine ER?

2 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Guanfacine ER NDC 72189-469 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-469Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0469Add 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
72189-469-30	7218904693072189046930	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-469-30)Marketed from May 4, 2023

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): Guanfacine ER
Generic name (nonproprietary): guanfacine er
Active ingredients: Guanfacine hydrochloride — 1 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Direct_RxNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205430
Marketing start: May 4, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha2-Agonists (Mechanism)
Identifiers: Product ID 72189-469_2c4def88-252f-7c8b-e063-6294a90aeb94SPL ID 2c4def88-252f-7c8b-e063-6294a90aeb94SPL set ID fae2df3c-2298-a3e1-e053-6294a90aeac4RxCUI 862006UNII PML56A160O
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

N472189046930 followed by a unit qualifier and the quantity

Package 72189-0469-30. 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 22, 2025.

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)].

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-469

What is NDC 72189-469?: 72189-469 is the product NDC for Guanfacine ER, Guanfacine hydrochloride 1 mg/1 tablet, extended release, listed with the FDA by Direct_Rx. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Guanfacine ER.
What is the active ingredient?: Guanfacine hydrochloride.
Who is the labeler?: Direct_Rx, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Guanfacine ER?: 2 other product NDCs are listed under this name. See all Guanfacine ER 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 Guanfacine ER NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Guanfacine ERguanfacine	Guanfacine hydrochloride 1 mg/1	Tablet, Extended releaseOral	Direct_Rx	72189-693	72189-0693-30
Guanfacine ER	Guanfacine hydrochloride 1 mg/1	Tablet, Extended releaseOral	Direct_rx	72189-597	72189-0597-30

Other NDCs under ANDA 205430

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

FDA NDC Directory listings under ANDA 205430
Product	Strength	Form · route	Labeler	Product NDC
Guanfacine extended-releaseguanfacine	Guanfacine hydrochloride 3 mg/1	Tablet, Extended releaseOral	A-S Medication Solutions	50090-6493
Guanfacine extended-releaseguanfacine	Guanfacine hydrochloride 1 mg/1	Tablet, Extended releaseOral	Apotex Corp.	60505-3927
Guanfacine extended-releaseguanfacine	Guanfacine hydrochloride 2 mg/1	Tablet, Extended releaseOral	Apotex Corp.	60505-3928
Guanfacine extended-releaseguanfacine	Guanfacine hydrochloride 3 mg/1	Tablet, Extended releaseOral	Apotex Corp.	60505-3929
Guanfacine extended-releaseguanfacine	Guanfacine hydrochloride 4 mg/1	Tablet, Extended releaseOral	Apotex Corp.	60505-3930
Guanfacine extended-releaseguanfacine	Guanfacine hydrochloride 2 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4266
Guanfacine extended-releaseguanfacine	Guanfacine hydrochloride 2 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	71335-2852
Guanfacine extended-releaseguanfacine	Guanfacine hydrochloride 4 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	71335-3005
Guanfacine extended-releaseguanfacine	Guanfacine hydrochloride 1 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	71335-3078
Guanfacine extended-releaseguanfacine	Guanfacine hydrochloride 2 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	71335-9750