Clonidine NDC 39822-2010

NDC codes

FDA NDC Directory

Product NDC (as listed)39822-2010Labeler and product segments. Claims need a package NDC.

Product NDC at billing width39822-2010Add 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
39822-2010-1	39822201001	10 mL in 1 VIAL, SINGLE-DOSE (39822-2010-1)Marketed from Oct 29, 2013

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): Clonidine
Generic name (nonproprietary): clonidine
Active ingredients: Clonidine hydrochloride — 500 ug/mL
Dosage form: Injection, Solution
Route: Epidural
Labeler: XGen Pharmaceuticals DJB, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203167
Marketing start: Oct 29, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha2-Agonists (Mechanism)
Identifiers: Product ID 39822-2010_103027a7-2f0d-8d8c-e063-6294a90aedc7SPL ID 103027a7-2f0d-8d8c-e063-6294a90aedc7SPL set ID ada02f1f-ae78-4435-879e-492ae862d504RxCUI 884221, 884225UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N439822201001 followed by a unit qualifier and the quantity

Package 39822-2010-01. 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 30, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Clonidine hydrochloride injection is indicated in combination with opiates for the treatment of severe pain in cancer patients that is not adequately relieved by opioid analgesics alone. Epidural clonidine is more likely to be effective in patients with neuropathic pain than somatic or visceral pain (see Clinical Trials ). The safety of this drug product has only been established in a highly selected group of cancer patients, and only after an adequate trial of opioid analgesia. Other use is of unproven safety and is not recommended. In a rare patient, the potential benefits may outweigh the known risks (see WARNINGS ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203167

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

FDA NDC Directory listings under ANDA 203167
Product	Strength	Form · route	Labeler	Product NDC
Clonidine	Clonidine hydrochloride 100 ug/mL	Injection, SolutionEpidural	XGen Pharmaceuticals DJB, Inc.	39822-2000