Guanfacine extended-release

Product NDC: 71335-3005
11-digit product format: 713353005
Labeler code: 71335
Product ID: 71335-3005_900c2e9f-b4cf-4e80-85a1-ddd42584e3aa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: guanfacine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA205430
Marketing category: ANDA
Marketing start: 2018-10-03
Substance: GUANFACINE HYDROCHLORIDE
Active strength: 4 mg/1
Pharmacologic classes: Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 71335-3005_900c2e9f-b4cf-4e80-85a1-ddd42584e3aa
SPL ID: 900c2e9f-b4cf-4e80-85a1-ddd42584e3aa
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: Guanfacine extended-release
Generic name: guanfacine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Marketing start: 2018-10-03
Marketing category: ANDA
Application number: ANDA205430
Pharmacologic classes: Adrenergic alpha2-Agonists [MoA]; Central alpha-2 Adrenergic Agonist [EPC]
Listing expiration: 2026-12-31

Ingredient	Strength
GUANFACINE HYDROCHLORIDE	4 mg/1

Package NDC	Description	Marketing start	Sample
71335-3005-1	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-3005-1)	2025-11-05	No

UNII	Preferred term	Registry number	Matched term
PML56A160O	GUANFACINE HYDROCHLORIDE	29110-48-3	GUANFACINE HYDROCHLORIDE
30OMY4G3MK	GUANFACINE	29110-47-2	guanfacine

Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71335-3005-1	71335300501	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-3005-1)	2025-11-05	No	No	Historical

Title	Manufacturer	Effective date	Type	Version
Guanfacine extended-release	Bryant Ranch Prepack	2025-11-05	HUMAN PRESCRIPTION DRUG LABEL	100