Prescription drug · ANDA

Guanfacine NDC 63304-924

Guanfacine hydrochloride 1 mg/1 · Tablet, Extended release · Oral · Sun Pharmaceutical Industries, Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)63304-924Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63304-0924Add 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 NDC11-digit (billing)PackageCopy
63304-924-0563304092405500 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-924-05)Marketed from Aug 17, 2018
63304-924-306330409243030 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-924-30)Marketed from Aug 17, 2018

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, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205689
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha2-Agonists (Mechanism)
Identifiers
Product ID 63304-924_536beff7-ed52-290c-e063-6294a90a0b2eSPL ID 536beff7-ed52-290c-e063-6294a90a0b2eSPL set ID 2d0a0f8e-5098-4ee2-a4ee-d026789923e2RxCUI 862006, 862013, 862019, 862025UNII PML56A160OUPC 0363304925012, 0363304926019, 0363304927016, 0363304924015
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

N463304092405 followed by a unit qualifier and the quantity

Package 63304-0924-05. 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 .

Indications (excerpt from the label)

Guanfacine extended-release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications [see Clinical Studies (14)] . Guanfacine extended-release tablets are 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).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 205689

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

FDA NDC Directory listings under ANDA 205689
ProductStrengthForm · routeLabelerProduct NDC
GuanfacineGuanfacine hydrochloride 1 mg/1Tablet, Extended releaseOralBryant Ranch Prepack63629-8161
GuanfacineGuanfacine hydrochloride 2 mg/1Tablet, Extended releaseOralBryant Ranch Prepack63629-8203
GuanfacineGuanfacine hydrochloride 2 mg/1Tablet, Extended releaseOralBryant Ranch Prepack72162-1799
GuanfacineGuanfacine hydrochloride 1 mg/1Tablet, Extended releaseOralBryant Ranch Prepack72162-1798
GuanfacineGuanfacine hydrochloride 4 mg/1Tablet, Extended releaseOralBryant Ranch Prepack72162-1801
GuanfacineGuanfacine hydrochloride 1 mg/1Tablet, Extended releaseOralNORTHSTAR RXLLC16714-190
GuanfacineGuanfacine hydrochloride 2 mg/1Tablet, Extended releaseOralNORTHSTAR RXLLC16714-191
GuanfacineGuanfacine hydrochloride 3 mg/1Tablet, Extended releaseOralNORTHSTAR RXLLC16714-192
GuanfacineGuanfacine hydrochloride 4 mg/1Tablet, Extended releaseOralNORTHSTAR RXLLC16714-193
GuanfacineGuanfacine hydrochloride 3 mg/1Tablet, Extended releaseOralSun Pharmaceutical Industries, Inc63304-926
GuanfacineGuanfacine hydrochloride 2 mg/1Tablet, Extended releaseOralSun Pharmaceutical Industries, Inc63304-925
GuanfacineGuanfacine hydrochloride 4 mg/1Tablet, Extended releaseOralSun Pharmaceutical Industries, Inc63304-927

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Guanfacine NDC 63304-924 | Med-Code