What is NDC 71034-001?

71034-001 is the product NDC for Clonidine Hydrochloride, Clonidine hydrochloride .1 mg/1 tablet, extended release, listed with the FDA by Xiamen LP Pharmaceutical Co., Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.

Xiamen LP Pharmaceutical Co., Ltd., NDC labeler code 71034. 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 71034-001

NDC codes

FDA NDC Directory

Product NDC (as listed)71034-001Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71034-0001Add 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
71034-001-60	7103400016071034000160	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71034-001-60)Marketed from Dec 1, 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 — .1 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Xiamen LP Pharmaceutical Co., Ltd.NDC labeler code 71034
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209757
Marketing start: Dec 1, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha2-Agonists (Mechanism)
Identifiers: Product ID 71034-001_b2b1f979-6a18-ad41-e053-2995a90ad14aSPL ID b2b1f979-6a18-ad41-e053-2995a90ad14aSPL set ID 7676af27-4d8f-49c4-a50f-6b0892e73c8fRxCUI 1013930UNII W76I6XXF06UPC 0371034001609
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

N471034000160 followed by a unit qualifier and the quantity

Package 71034-0001-60. 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 Oct 27, 2020.

Indications (excerpt from the label)

Clonidine hydrochloride extended-release tablets are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications [see C linical 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 71034-001

What is NDC 71034-001?: 71034-001 is the product NDC for Clonidine Hydrochloride, Clonidine hydrochloride .1 mg/1 tablet, extended release, listed with the FDA by Xiamen LP Pharmaceutical Co., Ltd.. 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?: Xiamen LP Pharmaceutical Co., Ltd., NDC labeler code 71034. 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 209757

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

FDA NDC Directory listings under ANDA 209757
Product	Strength	Form · route	Labeler	Product NDC
Clonidine Hydrochloride	Clonidine hydrochloride .1 mg/1	Tablet, Extended releaseOral	Solco Healthcare LLC	43547-435
Clonidine Hydrochloride	Clonidine hydrochloride .1 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	72162-1367