Prescription drug · ANDA

Guanfacine Extended-Release (Guanfacine) NDC 70518-3809

Guanfacine 2 mg/1 · Tablet, Extended release · Oral · REMEDYREPACK INC.

NDC codes

FDA NDC Directory
Product NDC (as listed)70518-3809Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-3809Add 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
70518-3809-0705183809007051838090030 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-3809-0)Marketed from Jul 29, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 2 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Labeler
REMEDYREPACK INC.NDC labeler code 70518
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 201408
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha2-Agonists (Mechanism)
Identifiers
Product ID 70518-3809_53c05b19-a005-532e-e063-6294a90a3a74SPL ID 53c05b19-a005-532e-e063-6294a90a3a74SPL set ID 3ec4fed6-cafc-49a0-9540-8d70ac435769RxCUI 862013UNII 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

N470518380900 followed by a unit qualifier and the quantity

Package 70518-3809-00. 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)

About NDC 70518-3809

What is NDC 70518-3809?
70518-3809 is the product NDC for Guanfacine Extended-Release (guanfacine), Guanfacine 2 mg/1 tablet, extended release, listed with the FDA by REMEDYREPACK INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Guanfacine Extended-Release (Guanfacine).
What is the active ingredient?
Guanfacine.
Who is the labeler?
REMEDYREPACK INC., NDC labeler code 70518. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Guanfacine Extended-Release?
22 other product NDCs are listed under this name. See all Guanfacine Extended-Release NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Guanfacine Extended-Release NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Guanfacine extended-releaseguanfacineGuanfacine hydrochloride 2 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-426670518-4266-00
Guanfacine Extended-ReleaseguanfacineGuanfacine 1 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-277170518-2771-0070518-2771-01
Guanfacine extended-releaseguanfacineGuanfacine hydrochloride 3 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-649350090-6493-00
Guanfacine extended-releaseguanfacineGuanfacine hydrochloride 1 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-307871335-3078-01
Guanfacine extended-releaseguanfacineGuanfacine hydrochloride 2 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-285271335-2852-01
Guanfacine extended-releaseguanfacineGuanfacine hydrochloride 2 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-975071335-9750-0171335-9750-02
Guanfacine extended-releaseguanfacineGuanfacine hydrochloride 4 mg/1Tablet, Extended releaseOralApotex Corp.60505-393060505-3930-01
Guanfacine extended-releaseguanfacineGuanfacine hydrochloride 1 mg/1Tablet, Extended releaseOralApotex Corp.60505-392760505-3927-01
Guanfacine extended-releaseguanfacineGuanfacine hydrochloride 2 mg/1Tablet, Extended releaseOralApotex Corp.60505-392860505-3928-01
Guanfacine extended-releaseguanfacineGuanfacine hydrochloride 3 mg/1Tablet, Extended releaseOralApotex Corp.60505-392960505-3929-01

All 23 Guanfacine Extended-Release NDCs

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 releaseOralUpsher-Smith Laboratories, LLC24979-533
Guanfacine Extended-ReleaseguanfacineGuanfacine 2 mg/1Tablet, Extended releaseOralUpsher-Smith Laboratories, LLC24979-534
Guanfacine Extended-ReleaseguanfacineGuanfacine 3 mg/1Tablet, Extended releaseOralUpsher-Smith Laboratories, LLC24979-536
Guanfacine Extended-ReleaseguanfacineGuanfacine 4 mg/1Tablet, Extended releaseOralUpsher-Smith Laboratories, LLC24979-538
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
Guanfacine Extended-ReleaseguanfacineGuanfacine 4 mg/1Tablet, Extended releaseOralGolden State Medical Supply, Inc.60429-963
Guanfacine Extended-ReleaseguanfacineGuanfacine 1 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-2771
Guanfacine Extended-ReleaseguanfacineGuanfacine 1 mg/1Tablet, Extended releaseOralProficient Rx LP71205-944
Guanfacine Extended-ReleaseguanfacineGuanfacine 2 mg/1Tablet, Extended releaseOralProficient Rx LP71205-945
Guanfacine Extended-ReleaseguanfacineGuanfacine 3 mg/1Tablet, Extended releaseOralProficient Rx LP71205-946
Guanfacine Extended-ReleaseguanfacineGuanfacine 4 mg/1Tablet, Extended releaseOralProficient Rx LP71205-947

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