NDC codes

FDA NDC Directory
Product NDC (as listed)60687-462Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60687-0462Add 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
60687-462-21606870462216068704622130 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-462-21) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (60687-462-11)Marketed from Dec 17, 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)
Clonidine hydrochloride
Generic name (nonproprietary)
clonidine hydrochloride
Active ingredients
Clonidine hydrochloride — .1 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Labeler
American Health PackagingNDC labeler code 60687
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209686
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha2-Agonists (Mechanism)
Identifiers
Product ID 60687-462_1a9e9967-92e8-a001-e063-6394a90a0204SPL ID 1a9e9967-92e8-a001-e063-6394a90a0204SPL set ID 95b390cc-0578-4cb0-9c08-4853388b2ec9RxCUI 1013930UNII W76I6XXF06
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

N460687046221 followed by a unit qualifier and the quantity

Package 60687-0462-21. 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)

Clonidine hydrochloride extended-release is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications [ see Clinical Studies (14) ]. Clonidine hydrochloride extended-release tablets are a centrally acting alpha 2 -adrenergic agonist indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy to stimulant medications. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 60687-462

What is NDC 60687-462?
60687-462 is the product NDC for Clonidine hydrochloride, Clonidine hydrochloride .1 mg/1 tablet, extended release, listed with the FDA by American Health Packaging. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Clonidine hydrochloride.
What is the active ingredient?
Clonidine hydrochloride.
Who is the labeler?
American Health Packaging, NDC labeler code 60687. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Clonidine hydrochloride?
140 other product NDCs are listed under this name. See all Clonidine hydrochloride 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 Clonidine hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
clonidine hydrochlorideClonidine hydrochloride .05 mg/1TabletOralAlembic Pharmaceuticals Inc.62332-16962332-0169-1062332-0169-3062332-0169-31+3 more
clonidine hydrochlorideClonidine hydrochloride .3 mg/1TabletOralCoupler LLC67046-064667046-0646-03
Clonidine HydrochlorideClonidine hydrochloride .2 mg/1TabletOralUnit Dose Solutions, Inc.87441-02487441-0024-01
Clonidine hydrochlorideClonidine hydrochloride .1 mg/1TabletOralUnit Dose Solutions, Inc.87441-02387441-0023-01
Clonidine hydrochlorideClonidine hydrochloride .05 mg/1TabletOralTruPharma, LLC52817-18352817-0183-10
Clonidine HydrochlorideClonidine hydrochloride .2 mg/1TabletOralMajor Pharmaceuticals0904-744300904-7443-61
Clonidine HydrochlorideClonidine hydrochloride .1 mg/1TabletOralCardinal Health 107, LLC55154-018955154-0189-00
Clonidine HydrochlorideClonidine hydrochloride .3 mg/1TabletOralREMEDYREPACK INC.70518-437970518-4379-00
Clonidine HydrochlorideClonidine hydrochloride .2 mg/1TabletOralREMEDYREPACK INC.70518-435770518-4357-00
Clonidine HydrochlorideClonidine hydrochloride .1 mg/1TabletOralREMEDYREPACK INC.70518-434270518-4342-0070518-4342-01

All 141 Clonidine hydrochloride NDCs

Other NDCs under ANDA 209686

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

FDA NDC Directory listings under ANDA 209686
ProductStrengthForm · routeLabelerProduct NDC
Clonidine hydrochlorideClonidine hydrochloride .1 mg/1Tablet, Extended releaseOralAjanta Pharma USA Inc.27241-108
Clonidine hydrochlorideClonidine hydrochloride .1 mg/1Tablet, Extended releaseOralBluePoint Laboratories68001-568

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