Prescription drug · ANDA

Guanfacine Extended-Release (Guanfacine) NDC 24979-538

Guanfacine 4 mg/1 · Tablet, Extended release · Oral · Upsher-Smith Laboratories, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)24979-538Labeler and product segments. Claims need a package NDC.
Product NDC at billing width24979-0538Add 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
24979-538-002497905380024979053800100000 TABLET, EXTENDED RELEASE in 1 DRUM (24979-538-00)Marketed from Jul 1, 2024
24979-538-012497905380124979053801100 TABLET, EXTENDED RELEASE in 1 BOTTLE (24979-538-01)Marketed from Jul 7, 2017
24979-538-1024979053810249790538101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (24979-538-10)Marketed from Jul 7, 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
Labeler
Upsher-Smith Laboratories, LLCNDC labeler code 24979
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 24979-538_df08cb67-1047-48bc-9f16-d3a40c2358deSPL ID df08cb67-1047-48bc-9f16-d3a40c2358de
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

N424979053800 followed by a unit qualifier and the quantity

Package 24979-0538-00. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 24979-538

What is NDC 24979-538?
24979-538 is the product NDC for Guanfacine Extended-Release (guanfacine), Guanfacine 4 mg/1 tablet, extended release, listed with the FDA by Upsher-Smith Laboratories, LLC. It has 3 package NDCs, 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?
Upsher-Smith Laboratories, LLC, NDC labeler code 24979. 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 2 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-380970518-3809-00
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

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 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 2 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-3809
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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