Quick answers
- What is Guanfacine used for?
- The FDA-approved label (Intuniv, Takeda Pharmaceuticals America, Inc., June 23, 2025) says: “INTUNIV ® is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications […]. INTUNIV is a central alpha 2A -adrenergic receptor agonist indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications ( 1, 14 ).” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Guanfacine have a boxed warning?
- No. None of the 57 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Guanfacine?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated November 13, 2025). Ask your pharmacist about alternatives.
- Has Guanfacine been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started March 31, 2021 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Guanfacine?
- 36 companies list prescription products of Guanfacine in the FDA NDC Directory, including Bryant Ranch Prepack, Remedyrepack Inc. and Golden State Medical Supply, Inc..
What Guanfacine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
INTUNIV ® is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications […]. INTUNIV is a central alpha 2A -adrenergic receptor agonist indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications ( 1, 14 ).
— FDA label: Intuniv, Takeda Pharmaceuticals America, Inc., effective June 23, 2025. Read the full label on DailyMed →
The FDA has 57 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 57 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, extended release · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 119 in the FDA NDC Directory |
| Brand names | Intuniv |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| guanfacine 1 mg tablet | Generic | $0.1544 per tablet |
| guanfacine 1 mg tablet, extended release | Generic | $0.1323 per tablet |
| guanfacine 2 mg tablet | Generic | $0.2742 per tablet |
| guanfacine 2 mg tablet, extended release | Generic | $0.1486 per tablet |
| guanfacine 3 mg tablet, extended release | Generic | $0.1756 per tablet |
| guanfacine 4 mg tablet, extended release | Generic | $0.1816 per tablet |
| guanfacine hydrochloride 1 mg tablet | Generic | $0.1544 per tablet |
| guanfacine hydrochloride 1 mg tablet, extended release | Generic | $0.1323 per tablet |
| guanfacine hydrochloride 1 mg tablet, extended release | Brand: Intuniv | $9.35 per tablet |
| guanfacine hydrochloride 2 mg tablet | Generic | $0.2742 per tablet |
| guanfacine hydrochloride 2 mg tablet, extended release | Generic | $0.1486 per tablet |
| guanfacine hydrochloride 2 mg tablet, extended release | Brand: Intuniv | $9.26 per tablet |
| guanfacine hydrochloride 3 mg tablet, extended release | Generic | $0.1756 per tablet |
| guanfacine hydrochloride 3 mg tablet, extended release | Brand: Intuniv | $9.29 per tablet |
| guanfacine hydrochloride 4 mg tablet, extended release | Generic | $0.1816 per tablet |
| guanfacine hydrochloride 4 mg tablet, extended release | Brand: Intuniv | $9.29 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack10 products
- Remedyrepack Inc.9 products
- Golden State Medical Supply, Inc.8 products
- Actavis Pharma, Inc.6 products
- Unichem Pharmaceuticals (USA), Inc.6 products
- Proficient Rx LP5 products
- A-S Medication Solutions4 products
- Alembic Pharmaceuticals Inc.4 products
- Slate Run Pharmaceuticals, LLC4 products
- Takeda Pharmaceuticals America, Inc.4 products
- Apotex Corp.4 products
- Fosun Pharma USA Inc.4 products
- Advagen Pharma Limited4 products
- NorthStar RxLLC4 products
- Alembic Pharmaceuticals Limited4 products
- Upsher-Smith Laboratories, LLC4 products
- Direct_Rx3 products
- i3 Pharmaceuticals, LLC2 products
- Xiromed, LLC2 products
- NorthStar Rx LLC2 products
- Amneal Pharmaceuticals of New York LLC2 products
- TWi Pharmaceuticals, Inc.2 products
- Ajanta Pharma USA Inc.2 products
- Epic Pharma, LLC2 products
- Amneal Pharmaceuticals LLC2 products
- Coupler LLC2 products
- Advagen Pharma Ltd2 products
- Aurobindo Pharma Limited2 products
- A2A Integrated Pharmaceuticals2 products
- Chartwell RX, LLC2 products
- Puracap Laboratories LLC dba Blu Pharmaceuticals1 product
- Precision Dose, Inc.1 product
- Major Pharmaceuticals1 product
- St. Mary's Medical Park Pharmacy1 product
- AvPAK1 product
- American Health Packaging1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022037 INTUNIV | Takeda Pharms USA | September 2, 2009 | 11, latest December 27, 2019 2019: Labeling · 2019: Labeling · 2018: Labeling |
Generic approvals (19)
- ANDA074145Watson Labs · October 17, 1995
- ANDA074796Aurobindo Pharma USA · January 27, 1997
- ANDA074673Epic Pharma LLC · February 28, 1997
- ANDA075109Amneal Pharm · November 25, 1998
- ANDA200881Actavis Elizabeth · October 5, 2012
- ANDA201408Twi Pharms · June 2, 2015
- ANDA205689Sun Pharm · November 16, 2017
- ANDA205430Apotex · July 25, 2018
- ANDA213428Yichang Humanwell · November 25, 2020
- ANDA214689Unichem · March 3, 2021
- ANDA216399Aiping Pharm Inc · June 8, 2022
- ANDA217293Ajanta Pharma Ltd · April 27, 2023
- ANDA217269Alembic · August 7, 2023
- ANDA216828Pharmazone · October 5, 2023
- ANDA216762Rubicon Research · October 17, 2023
- ANDA218326Xiromed · February 23, 2024
- ANDA217638Fosun Wanbang · June 12, 2024
- ANDA219033Unichem · November 19, 2024
- ANDA219689Rubicon Research · April 15, 2025
Shortage status
To be discontinued · updated November 13, 2025 · first posted November 13, 2025
| Product | Guanfacine Hydrochloride, Tablet, Extended Release, 3 mg (NDC 0228-2853-11) |
|---|---|
| Company | Actavis Pharma, Inc. |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
March 31, 2021 · Class II · Ongoing · D-0324-2021
Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate
Guanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326, NDC 60505-3928-1, UPC 3 60505 39281 — Apotex Corp.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Intuniv, Takeda Pharmaceuticals America, Inc., effective June 23, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →