Guanfacine Hydrochloride (guanfacine) NDC 53746-711

NDC codes

FDA NDC Directory

Product NDC (as listed)53746-711Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53746-0711Add 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
53746-711-01	53746071101	100 TABLET in 1 BOTTLE (53746-711-01)Marketed from Apr 15, 2022

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 — 1 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Amneal Pharmaceuticals of New York LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075109
Marketing start: Apr 15, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic alpha2-Agonists (Mechanism)
Identifiers: Product ID 53746-711_98111f92-dc41-4939-b554-65b3f97a3e19SPL ID 98111f92-dc41-4939-b554-65b3f97a3e19SPL set ID 73d50917-c807-4213-8efe-aea209845936RxCUI 197745, 197746UNII PML56A160OUPC 0353746711014, 0353746713018
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

N453746071101 followed by a unit qualifier and the quantity

Package 53746-0711-01. 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 Apr 14, 2026.

Indications (excerpt from the label)

INDICATIONS & 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)

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 2 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-713
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