Guanfacine NDC 0591-0453

NDC codes

FDA NDC Directory

Product NDC (as listed)0591-0453Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00591-0453Add 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
0591-0453-01	00591045301	100 TABLET in 1 BOTTLE (0591-0453-01)Marketed from Oct 17, 1995

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
Generic name (nonproprietary): guanfacine
Active ingredients: Guanfacine hydrochloride — 2 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Actavis Pharma, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 074145
Marketing start: Oct 17, 1995
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha2-Agonists (Mechanism)
Identifiers: Product ID 0591-0453_3ed0b0fa-4fd2-494b-ba55-52fcf77bc9d6SPL ID 3ed0b0fa-4fd2-494b-ba55-52fcf77bc9d6SPL set ID a81b956b-f004-4426-ba20-375ccf21eb71RxCUI 197745, 197746UNII PML56A160OUPC 0305910453015, 0305910444013
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

N400591045301 followed by a unit qualifier and the quantity

Package 00591-0453-01. 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 Oct 10, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE Guanfacine tablets, USP are indicated in the management of hypertension. Guanfacine tablets, USP 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 074145

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

FDA NDC Directory listings under ANDA 074145
Product	Strength	Form · route	Labeler	Product NDC
Guanfacine	Guanfacine hydrochloride 1 mg/1	TabletOral	Actavis Pharma, Inc.	0591-0444