Guanfacine NDC 42806-048

NDC codes

FDA NDC Directory

Product NDC (as listed)42806-048Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42806-0048Add 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
42806-048-01	42806004801	100 TABLET in 1 BOTTLE (42806-048-01)Marketed from Dec 2, 2013

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
Generic name (nonproprietary): guanfacine
Active ingredients: Guanfacine hydrochloride — 1 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Epic Pharma, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 074673
Marketing start: Dec 2, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha2-Agonists (Mechanism)
Identifiers: Product ID 42806-048_d0ca35de-12e8-4154-825a-c82eed36efd7SPL ID d0ca35de-12e8-4154-825a-c82eed36efd7SPL set ID fac4a4c2-f5f0-46ef-b76b-315abe9136faRxCUI 197745, 197746UNII 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

N442806004801 followed by a unit qualifier and the quantity

Package 42806-0048-01. 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 Nov 8, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE Guanfacine hydrochloride 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 074673

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

FDA NDC Directory listings under ANDA 074673
Product	Strength	Form · route	Labeler	Product NDC
Guanfacine	Guanfacine hydrochloride 2 mg/1	TabletOral	Epic Pharma, LLC	42806-296
Guanfacine	Guanfacine hydrochloride 1 mg/1	TabletOral	Proficient Rx LP	63187-302
Guanfacine	Guanfacine hydrochloride 1 mg/1	TabletOral	Major Pharmaceuticals	0904-7140
Guanfacine	Guanfacine hydrochloride 1 mg/1	TabletOral	PuraCap Laboratories LLC dba Blu Pharmaceuticals	24658-730