NDC codes

FDA NDC Directory
Product NDC (as listed)42806-296Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42806-0296Add 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
42806-296-014280602960142806029601100 TABLET in 1 BOTTLE (42806-296-01)Marketed from May 30, 2019

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 — 2 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Epic Pharma, LLCNDC labeler code 42806
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 074673
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha2-Agonists (Mechanism)
Identifiers
Product ID 42806-296_d0ca35de-12e8-4154-825a-c82eed36efd7SPL ID d0ca35de-12e8-4154-825a-c82eed36efd7SPL set ID fac4a4c2-f5f0-46ef-b76b-315abe9136faRxCUI 197745, 197746UNII PML56A160O
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

N442806029601 followed by a unit qualifier and the quantity

Package 42806-0296-01. 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)

INDICATIONS AND USAGE Guanfacine hydrochloride tablets are indicated in the management of hypertension. Guanfacine may be given alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42806-296

What is NDC 42806-296?
42806-296 is the product NDC for Guanfacine, Guanfacine hydrochloride 2 mg/1 tablet, listed with the FDA by Epic Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Guanfacine.
What is the active ingredient?
Guanfacine hydrochloride.
Who is the labeler?
Epic Pharma, LLC, NDC labeler code 42806. 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?
71 other product NDCs are listed under this name. See all Guanfacine 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 NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
GuanfacineGuanfacine hydrochloride 2 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-467570518-4675-00
GuanfacineGuanfacine hydrochloride 4 mg/1Tablet, Extended releaseOralFosun Pharma USA, Inc72266-25872266-0258-55
GuanfacinegaunfacineGuanfacine hydrochloride 2 mg/1TabletOralREMEDYREPACK INC.70518-456470518-4564-00
GuanfacineGuanfacine hydrochloride 2 mg/1TabletOralCoupler LLC67046-165567046-1655-03
GuanfacineGuanfacine hydrochloride 1 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-453970518-4539-00
GuanfacineGuanfacine hydrochloride 1 mg/1Tablet, Extended releaseOralFosun Pharma USA, Inc72266-25572266-0255-55
GuanfacineGuanfacine hydrochloride 2 mg/1Tablet, Extended releaseOralFosun Pharma USA, Inc72266-25672266-0256-55
GuanfacineGuanfacine hydrochloride 3 mg/1Tablet, Extended releaseOralFosun Pharma USA, Inc72266-25772266-0257-55
GuanfacineGuanfacine hydrochloride 2 mg/1TabletOralREMEDYREPACK INC.70518-448870518-4488-00
GuanfacineGuanfacine hydrochloride 1 mg/1Tablet, Extended releaseOralSt. Mary's Medical Park Pharmacy60760-86360760-0863-30

All 72 Guanfacine NDCs

Other NDCs under ANDA 074673

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

FDA NDC Directory listings under ANDA 074673
ProductStrengthForm · routeLabelerProduct NDC
GuanfacineGuanfacine hydrochloride 1 mg/1TabletOralMajor Pharmaceuticals0904-7140
GuanfacineGuanfacine hydrochloride 1 mg/1TabletOralPuraCap Laboratories LLC dba Blu Pharmaceuticals24658-730
GuanfacineGuanfacine hydrochloride 1 mg/1TabletOralEpic Pharma, LLC42806-048
GuanfacineGuanfacine hydrochloride 1 mg/1TabletOralProficient Rx LP63187-302

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