Guanfacine Hydrochloride NDC 29300-459

NDC codes

FDA NDC Directory

Product NDC (as listed)29300-459Labeler and product segments. Claims need a package NDC.

Product NDC at billing width29300-0459Add 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
29300-459-01	29300045901	100 TABLET in 1 BOTTLE (29300-459-01)Marketed from Apr 5, 2021

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 hydrochloride
Active ingredients: Guanfacine — 2 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Unichem Pharmaceuticals (USA), Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214689
Marketing start: Mar 3, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha2-Agonists (Mechanism)
Identifiers: Product ID 29300-459_9df9e7f8-a9b3-4919-94f9-07c81ff7c8b3SPL ID 9df9e7f8-a9b3-4919-94f9-07c81ff7c8b3SPL set ID 14146031-8d56-469b-8de8-fe3cf1712e78RxCUI 197745, 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

N429300045901 followed by a unit qualifier and the quantity

Package 29300-0459-01. 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 Mar 30, 2021.

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 1 mg/1	TabletOral	American Health Packaging	60687-710
Guanfacine Hydrochloride	Guanfacine 2 mg/1	TabletOral	REMEDYREPACK INC.	70518-3516
Guanfacine Hydrochloride	Guanfacine 1 mg/1	TabletOral	Unichem Pharmaceuticals (USA), Inc.	29300-458