NDC codes

FDA NDC Directory
Product NDC (as listed)70518-4333Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-4333Add 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
70518-4333-0705184333007051843330030 TABLET in 1 BLISTER PACK (70518-4333-0)Marketed from Apr 25, 2025

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
Generic name (nonproprietary)
guanfacine
Active ingredients
Guanfacine hydrochloride — 1 mg/1
Dosage form
Tablet
Route
Oral
Labeler
REMEDYREPACK INC.NDC labeler code 70518
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 217293
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha2-Agonists (Mechanism)
Identifiers
Product ID 70518-4333_5aacb003-7345-9416-e063-6294a90ae94cSPL ID 5aacb003-7345-9416-e063-6294a90ae94cSPL set ID 04a3bd2d-9a9c-43e8-a0e2-280e02265f16RxCUI 197745UNII 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

N470518433300 followed by a unit qualifier and the quantity

Package 70518-4333-00. 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)

INDICATIONS AND USAGE Guanfacine tablets, USP are indicated in the management of hypertension. Guanfacine tablets, USP 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 70518-4333

What is NDC 70518-4333?
70518-4333 is the product NDC for Guanfacine, Guanfacine hydrochloride 1 mg/1 tablet, 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.
What is the active ingredient?
Guanfacine hydrochloride.
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?
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 217293

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

FDA NDC Directory listings under ANDA 217293
ProductStrengthForm · routeLabelerProduct NDC
GuanfacineGuanfacine hydrochloride 1 mg/1TabletOralAjanta Pharma USA Inc.27241-242
GuanfacineGuanfacine hydrochloride 2 mg/1TabletOralAjanta Pharma USA Inc.27241-243
GuanfacineGuanfacine hydrochloride 1 mg/1TabletOralCoupler LLC67046-1433
GuanfacineGuanfacine hydrochloride 2 mg/1TabletOralCoupler LLC67046-1655
GuanfacineGuanfacine hydrochloride 2 mg/1TabletOralREMEDYREPACK INC.70518-4488

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