What is NDC 72603-269?

72603-269 is the product NDC for Guanfacine Hydrochloride, Guanfacine hydrochloride 2 mg/1 tablet, listed with the FDA by NORTHSTAR RX LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

NORTHSTAR RX LLC, NDC labeler code 72603. 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 Hydrochloride?

18 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Guanfacine Hydrochloride NDC 72603-269

NDC codes

FDA NDC Directory

Product NDC (as listed)72603-269Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72603-0269Add 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
72603-269-01	7260302690172603026901	100 TABLET in 1 BOTTLE (72603-269-01)Marketed from Jul 15, 2024

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 Hydrochloride
Generic name (nonproprietary): guanfacine hydrochloride
Active ingredients: Guanfacine hydrochloride — 2 mg/1
Dosage form: Tablet
Route: Oral
Labeler: NORTHSTAR RX LLCNDC labeler code 72603
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218326
Marketing start: Jul 15, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha2-Agonists (Mechanism)
Identifiers: Product ID 72603-269_34444967-f5f1-a36d-a394-95e01c65eb8fSPL ID 34444967-f5f1-a36d-a394-95e01c65eb8fSPL set ID 83d0739b-46fd-6228-e85c-089611067a35RxCUI 197745, 197746UNII PML56A160OUPC 0372603268010
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

N472603026901 followed by a unit qualifier and the quantity

Package 72603-0269-01. 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 Jul 15, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Guanfacine tablets are indicated in the management of hypertension. Guanfacine may be given alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72603-269

What is NDC 72603-269?: 72603-269 is the product NDC for Guanfacine Hydrochloride, Guanfacine hydrochloride 2 mg/1 tablet, listed with the FDA by NORTHSTAR RX LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Guanfacine Hydrochloride.
What is the active ingredient?: Guanfacine hydrochloride.
Who is the labeler?: NORTHSTAR RX LLC, NDC labeler code 72603. 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 Hydrochloride?: 18 other product NDCs are listed under this name. See all Guanfacine Hydrochloride 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 Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Guanfacine Hydrochloride	Guanfacine hydrochloride 1 mg/1	TabletOral	NORTHSTAR RX LLC	72603-268	72603-0268-01
Guanfacine Hydrochloride	Guanfacine hydrochloride 1 mg/1	TabletOral	XIROMED, LLC	70700-301	70700-0301-0170700-0301-30
Guanfacine Hydrochloride	Guanfacine hydrochloride 2 mg/1	TabletOral	XIROMED, LLC	70700-302	70700-0302-0170700-0302-0570700-0302-30
Guanfacine Hydrochloride	Guanfacine 1 mg/1	TabletOral	American Health Packaging	60687-710	60687-0710-21
Guanfacine Hydrochlorideguanfacine	Guanfacine hydrochloride 1 mg/1	TabletOral	Precision Dose, Inc.	68094-065	68094-0065-62
Guanfacine Hydrochloride	Guanfacine 2 mg/1	TabletOral	REMEDYREPACK INC.	70518-3516	70518-3516-00
Guanfacine Hydrochlorideguanfacine	Guanfacine hydrochloride 1 mg/1	TabletOral	TWi Pharmaceuticals, Inc.	24979-198	24979-0198-01
Guanfacine Hydrochlorideguanfacine	Guanfacine hydrochloride 2 mg/1	TabletOral	TWi Pharmaceuticals, Inc.	24979-199	24979-0199-01
Guanfacine Hydrochlorideguanfacine	Guanfacine hydrochloride 1 mg/1	TabletOral	Chartwell RX, LLC	62135-727	62135-0727-90
Guanfacine Hydrochlorideguanfacine	Guanfacine hydrochloride 2 mg/1	TabletOral	Chartwell RX, LLC	62135-728	62135-0728-90

All 19 Guanfacine Hydrochloride NDCs

Other NDCs under ANDA 218326

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

FDA NDC Directory listings under ANDA 218326
Product	Strength	Form · route	Labeler	Product NDC
Guanfacine Hydrochloride	Guanfacine hydrochloride 1 mg/1	TabletOral	XIROMED, LLC	70700-301
Guanfacine Hydrochloride	Guanfacine hydrochloride 2 mg/1	TabletOral	XIROMED, LLC	70700-302
Guanfacine Hydrochloride	Guanfacine hydrochloride 1 mg/1	TabletOral	NORTHSTAR RX LLC	72603-268