What is NDC 68134-603?

68134-603 is the product NDC for Clonidine, Clonidine .17 mg/1 tablet, extended release, listed with the FDA by PALMETTO PHARMACEUTICALS INC.. It has 1 package NDC, shown above in 10- and 11-digit form.

PALMETTO PHARMACEUTICALS INC., NDC labeler code 68134. 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?

11 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Clonidine NDC 68134-603 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68134-603Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68134-0603Add 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 NDC	11-digit (billing)	Package	Copy
68134-603-30	6813406033068134060330	30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (68134-603-30)Marketed from Mar 1, 2022

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
Generic name (nonproprietary): clonidine
Active ingredients: Clonidine — .17 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: PALMETTO PHARMACEUTICALS INC.NDC labeler code 68134
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 022500
Marketing start: Mar 1, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha2-Agonists (Mechanism)
Identifiers: Product ID 68134-603_0eb6eb87-c779-3b79-e063-6294a90a5944SPL ID 0eb6eb87-c779-3b79-e063-6294a90a5944SPL set ID e93324f1-ad83-7bbe-e053-2995a90a8c9eRxCUI 885880UNII MN3L5RMN02UPC 0368134603307
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

N468134060330 followed by a unit qualifier and the quantity

Package 68134-0603-30. 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 Jan 11, 2024.

Indications (excerpt from the label)

Clonidine extended-release tablets are indicated in the treatment of hypertension. Clonidine extended-release tablets may be employed alone or concomitantly with other antihypertensive agents. Clonidine extended-release tablets are a central alpha-adrenergic agonist indicated for: Treatment of hypertension ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68134-603

What is NDC 68134-603?: 68134-603 is the product NDC for Clonidine, Clonidine .17 mg/1 tablet, extended release, listed with the FDA by PALMETTO PHARMACEUTICALS INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Clonidine.
What is the active ingredient?: Clonidine.
Who is the labeler?: PALMETTO PHARMACEUTICALS INC., NDC labeler code 68134. 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?: 11 other product NDCs are listed under this name. See all Clonidine 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 NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Clonidine	Clonidine .1 mg/24h	Patch, Extended releaseTransdermal	Dr. Reddy's Labratories Inc.	75907-023	75907-0023-48
Clonidine	Clonidine .2 mg/24h	Patch, Extended releaseTransdermal	Dr. Reddy's Labratories Inc.	75907-024	75907-0024-48
Clonidine	Clonidine .3 mg/24h	Patch, Extended releaseTransdermal	Dr. Reddy's Labratories Inc.	75907-025	75907-0025-48
Clonidine	Clonidine .17 mg/1	Tablet, Extended releaseOral	TruPharma, LLC	52817-375	52817-0375-30
Clonidine	Clonidine hydrochloride .1 mg/1	Tablet, Extended releaseOral	Ingenus Pharmaceuticals, LLC	50742-247	50742-0247-0550742-0247-3050742-0247-60
Clonidine	Clonidine .3 mg/24h	Patch, Extended releaseTransdermal	Mayne Pharma Inc.	51862-455	—
Clonidine	Clonidine hydrochloride 100 ug/mL	Injection, SolutionEpidural	XGen Pharmaceuticals DJB, Inc.	39822-2000	39822-2000-01
Clonidine	Clonidine hydrochloride 500 ug/mL	Injection, SolutionEpidural	XGen Pharmaceuticals DJB, Inc.	39822-2010	39822-2010-01
Clonidine	Clonidine .2 mg/d	PatchTransdermal	Mylan Pharmaceuticals Inc.	0378-0872	00378-0872-99
Clonidine	Clonidine .3 mg/d	PatchTransdermal	Mylan Pharmaceuticals Inc.	0378-0873	00378-0873-99

All 12 Clonidine NDCs

Other NDCs under NDA 022500

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

FDA NDC Directory listings under NDA 022500
Product	Strength	Form · route	Labeler	Product NDC
Clonidine	Clonidine .17 mg/1	Tablet, Extended releaseOral	TruPharma, LLC	52817-375
Nexiclon XRclonidine	Clonidine .17 mg/1	Tablet, Extended releaseOral	Rosemont Pharmaceuticals LLC	71511-503