Guanfacine Hydrochloride NDC 70518-3516

NDC codes

FDA NDC Directory

Product NDC (as listed)70518-3516Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70518-3516Add 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
70518-3516-0	70518351600	30 TABLET in 1 BLISTER PACK (70518-3516-0)Marketed from Sep 13, 2022

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 2 mg/1
Dosage form: Tablet
Route: Oral
Labeler: REMEDYREPACK INC.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214689
Marketing start: Sep 13, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic alpha2-Agonists (Mechanism)
Identifiers: Product ID 70518-3516_4f1ff1f7-c445-fc56-e063-6294a90a1d7fSPL ID 4f1ff1f7-c445-fc56-e063-6294a90a1d7fSPL set ID 1b1063ba-fee3-4540-9139-db4b915f82e2RxCUI 197746UNII 30OMY4G3MK
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

N470518351600 followed by a unit qualifier and the quantity

Package 70518-3516-00. 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 10, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Guanfacine tablets are indicated in the management of hypertension. Guanfacine tablets 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 214689

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

FDA NDC Directory listings under ANDA 214689
Product	Strength	Form · route	Labeler	Product NDC
Guanfacine Hydrochloride	Guanfacine 2 mg/1	TabletOral	Unichem Pharmaceuticals (USA), Inc.	29300-459
Guanfacine Hydrochloride	Guanfacine 1 mg/1	TabletOral	American Health Packaging	60687-710
Guanfacine Hydrochloride	Guanfacine 1 mg/1	TabletOral	Unichem Pharmaceuticals (USA), Inc.	29300-458