Guanfacine Hydrochloride (guanfacine) NDC 65162-713

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-713Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0713Add 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
65162-713-03	65162071303	30 TABLET in 1 BOTTLE (65162-713-03)Marketed from Nov 25, 1998
65162-713-10	65162071310	100 TABLET in 1 BOTTLE (65162-713-10)Marketed from Nov 25, 1998
65162-713-50	65162071350	500 TABLET in 1 BOTTLE (65162-713-50)Marketed from Nov 25, 1998

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
Active ingredients: Guanfacine hydrochloride — 2 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Amneal Pharmaceuticals LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075109
Marketing start: Nov 25, 1998
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha2-Agonists (Mechanism)
Identifiers: Product ID 65162-713_2742ab0e-0dcc-4be7-8356-ea7ba8dfe6a7SPL ID 2742ab0e-0dcc-4be7-8356-ea7ba8dfe6a7SPL set ID d9fdc4b4-5b00-46dd-8700-6e36ceaafb0eRxCUI 197745, 197746UNII PML56A160OUPC 0365162713039, 0365162711035
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

N465162071303 followed by a unit qualifier and the quantity

Package 65162-0713-03. 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 25, 2024.

Indications (excerpt from the label)

INDICATIONS & USAGE Guanfacine tablets, USP 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)

Other NDCs under ANDA 075109

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

FDA NDC Directory listings under ANDA 075109
Product	Strength	Form · route	Labeler	Product NDC
Guanfacine Hydrochlorideguanfacine	Guanfacine hydrochloride 2 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-713
Guanfacine Hydrochlorideguanfacine	Guanfacine hydrochloride 2 mg/1	TabletOral	AvPAK	50268-374
Guanfacine Hydrochlorideguanfacine	Guanfacine hydrochloride 1 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-711
Guanfacine Hydrochlorideguanfacine	Guanfacine hydrochloride 1 mg/1	TabletOral	A-S Medication Solutions	50090-6073
Guanfacine Hydrochlorideguanfacine	Guanfacine hydrochloride 1 mg/1	TabletOral	Precision Dose, Inc.	68094-065
Guanfacine Hydrochlorideguanfacine	Guanfacine hydrochloride 1 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-711