Duraclon (clonidine hydrochloride) NDC 67457-218

NDC codes

FDA NDC Directory

Product NDC (as listed)67457-218Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67457-0218Add 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
67457-218-10	67457021810	1 VIAL in 1 CARTON (67457-218-10) / 10 mL in 1 VIALMarketed from Jan 26, 1997

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): Duraclon
Generic name (nonproprietary): clonidine hydrochloride
Active ingredients: Clonidine hydrochloride — .1 mg/mL
Dosage form: Injection, Solution
Route: Epidural
Labeler: Mylan Institutional LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 020615
Marketing start: Jan 26, 1997
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha2-Agonists (Mechanism)
Identifiers: Product ID 67457-218_671a0224-c38b-4f2e-a132-fa38aa1a0797SPL ID 671a0224-c38b-4f2e-a132-fa38aa1a0797SPL set ID 8c126bb8-732a-4949-8754-2f50b5543638RxCUI 884221, 884223UNII 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

N467457021810 followed by a unit qualifier and the quantity

Package 67457-0218-10. 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 Mar 17, 2021. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Duraclon 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)