What is NDC 43353-316?

43353-316 is the product NDC for Clonidine Hydrochloride, Clonidine hydrochloride .3 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 43353. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Clonidine Hydrochloride NDC 43353-316

NDC codes

FDA NDC Directory

Product NDC (as listed)43353-316Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43353-0316Add 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
43353-316-09	4335303160943353031609	9000 TABLET in 1 BOTTLE (43353-316-09)Marketed from May 3, 2017

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 — .3 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 43353
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 070976
Marketing start: Jan 3, 1995
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha2-Agonists (Mechanism)
Identifiers: Product ID 43353-316_2bf1938a-b415-4fb4-bb25-c3fc89ed1462SPL ID 2bf1938a-b415-4fb4-bb25-c3fc89ed1462SPL set ID e9b22c56-a3fc-46df-b745-11c4ac309a91RxCUI 884189UNII 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

N443353031609 followed by a unit qualifier and the quantity

Package 43353-0316-09. 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 May 3, 2017.

Indications (excerpt from the label)

INDICATIONS AND USAGE Clonidine hydrochloride tablets, USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets may be employed alone or concomitantly with other antihypertensive agents.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43353-316

What is NDC 43353-316?: 43353-316 is the product NDC for Clonidine Hydrochloride, Clonidine hydrochloride .3 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. 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?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 43353. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
clonidine hydrochloride	Clonidine hydrochloride .05 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-169	62332-0169-1062332-0169-3062332-0169-31+3 more
clonidine hydrochloride	Clonidine hydrochloride .3 mg/1	TabletOral	Coupler LLC	67046-0646	67046-0646-03
Clonidine Hydrochloride	Clonidine hydrochloride .2 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-024	87441-0024-01
Clonidine hydrochloride	Clonidine hydrochloride .1 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-023	87441-0023-01
Clonidine hydrochloride	Clonidine hydrochloride .05 mg/1	TabletOral	TruPharma, LLC	52817-183	52817-0183-10
Clonidine Hydrochloride	Clonidine hydrochloride .2 mg/1	TabletOral	Major Pharmaceuticals	0904-7443	00904-7443-61
Clonidine Hydrochloride	Clonidine hydrochloride .1 mg/1	TabletOral	Cardinal Health 107, LLC	55154-0189	55154-0189-00
Clonidine Hydrochloride	Clonidine hydrochloride .3 mg/1	TabletOral	REMEDYREPACK INC.	70518-4379	70518-4379-00
Clonidine Hydrochloride	Clonidine hydrochloride .2 mg/1	TabletOral	REMEDYREPACK INC.	70518-4357	70518-4357-00
Clonidine Hydrochloride	Clonidine hydrochloride .1 mg/1	TabletOral	REMEDYREPACK INC.	70518-4342	70518-4342-0070518-4342-01

All 141 Clonidine Hydrochloride NDCs

Other NDCs under ANDA 070976

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

FDA NDC Directory listings under ANDA 070976
Product	Strength	Form · route	Labeler	Product NDC
Clonidine Hydrochloride	Clonidine hydrochloride .3 mg/1	TabletOral	Actavis Pharma, Inc.	0228-2129
Clonidine Hydrochloride	Clonidine hydrochloride .3 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-2574
Clonidine Hydrochloride	Clonidine hydrochloride .3 mg/1	TabletOral	BluePoint Laboratories	68001-239