Prescription drug · ANDA

Guanfacine Extended-Release (guanfacine) NDC 60429-963

Guanfacine 4 mg/1 · Tablet, Extended release · Oral · Golden State Medical Supply, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)60429-963Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60429-0963Add 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
60429-963-0160429096301100 TABLET, EXTENDED RELEASE in 1 BOTTLE (60429-963-01)Marketed from Oct 6, 2017

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 Extended-ReleaseSuffix: Extended-Release
Generic name (nonproprietary)
guanfacine
Active ingredients
Guanfacine — 4 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 201408
Marketing start
Marketing end
Other FDA classes
Adrenergic alpha2-Agonists (Mechanism)
Identifiers
Product ID 60429-963_52d4ad1f-7382-4944-e063-6294a90a004bSPL ID 52d4ad1f-7382-4944-e063-6294a90a004bSPL set ID 6006df06-0448-462d-b81e-7add50a6d71bRxCUI 862006, 862013, 862019, 862025UNII 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

N460429096301 followed by a unit qualifier and the quantity

Package 60429-0963-01. 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 .

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 central alpha 2A -adrenergic receptor agonist indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapyand 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 201408

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

FDA NDC Directory listings under ANDA 201408
ProductStrengthForm · routeLabelerProduct NDC
Guanfacine Extended-ReleaseguanfacineGuanfacine 1 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-2771
Guanfacine Extended-ReleaseguanfacineGuanfacine 2 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-3809
Guanfacine Extended-ReleaseguanfacineGuanfacine 3 mg/1Tablet, Extended releaseOralUpsher-Smith Laboratories, LLC24979-536
Guanfacine Extended-ReleaseguanfacineGuanfacine 1 mg/1Tablet, Extended releaseOralUpsher-Smith Laboratories, LLC24979-533
Guanfacine Extended-ReleaseguanfacineGuanfacine 2 mg/1Tablet, Extended releaseOralUpsher-Smith Laboratories, LLC24979-534
Guanfacine Extended-ReleaseguanfacineGuanfacine 4 mg/1Tablet, Extended releaseOralUpsher-Smith Laboratories, LLC24979-538
Guanfacine Extended-ReleaseguanfacineGuanfacine 2 mg/1Tablet, Extended releaseOralProficient Rx LP71205-945
Guanfacine Extended-ReleaseguanfacineGuanfacine 1 mg/1Tablet, Extended releaseOralProficient Rx LP71205-944
Guanfacine Extended-ReleaseguanfacineGuanfacine 3 mg/1Tablet, Extended releaseOralProficient Rx LP71205-946
Guanfacine Extended-ReleaseguanfacineGuanfacine 4 mg/1Tablet, Extended releaseOralProficient Rx LP71205-947
Guanfacine Extended-ReleaseguanfacineGuanfacine 1 mg/1Tablet, Extended releaseOralGolden State Medical Supply, Inc.60429-960
Guanfacine Extended-ReleaseguanfacineGuanfacine 2 mg/1Tablet, Extended releaseOralGolden State Medical Supply, Inc.60429-961
Guanfacine Extended-ReleaseguanfacineGuanfacine 3 mg/1Tablet, Extended releaseOralGolden State Medical Supply, Inc.60429-962

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Guanfacine Extended-Release (guanfacine) NDC 60429-963 | Med-Code