Unfinished product

This listing is a drug for further processing, not a finished drug product dispensed or administered to patients. It is not normally billed.

NDC codes

FDA NDC Directory
Product NDC (as listed)0591-0444Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00591-0444Add 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
0591-0444-00005910444000059104440077000 TABLET in 1 BAG (0591-0444-00)Marketed from 17-OCT-95
0591-0444-77005910444770059104447792304 TABLET in 1 CONTAINER (0591-0444-77)Marketed from 30-JUN-24

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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

Generic name (nonproprietary)
guanfacine
Active ingredients
Guanfacine hydrochloride — 1 mg/1
Dosage form
Tablet
Labeler
Actavis Pharma, Inc.NDC labeler code 0591
Product type
Drug for further processing
Marketing category
Drug for further processing
Marketing start
Listing expires
Identifiers
Product ID 0591-0444_788cfc7d-4261-437f-a939-c156ecf778c1SPL ID 788cfc7d-4261-437f-a939-c156ecf778c1

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N400591044400 followed by a unit qualifier and the quantity

Package 00591-0444-00. 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 0591-0444

What is NDC 0591-0444?
0591-0444 is the product NDC for Guanfacine, Guanfacine hydrochloride 1 mg/1 tablet, listed with the FDA by Actavis Pharma, Inc.. It has 2 package NDCs, 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?
Actavis Pharma, Inc., NDC labeler code 0591. 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

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