Prescription drug · NDA
Qlonilik (Clonidine hydrochloride) NDC 46287-085
Clonidine hydrochloride .05 mg/mL · Solution · Oral · CMP Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46287-085-04 | 4628700850446287008504 | 120 mL in 1 BOTTLE (46287-085-04)Marketed from Aug 28, 2026 |
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)
- Qlonilik
- Generic name (nonproprietary)
- clonidine hydrochloride
- Active ingredients
- Clonidine hydrochloride — .05 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- CMP Pharma, Inc.NDC labeler code 46287
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 221094
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 46287-085_9d9a0953-57dd-439d-a354-826284f56725SPL ID 9d9a0953-57dd-439d-a354-826284f56725SPL set ID 826de1dc-378e-4c90-86d1-e33f7a4248cdRxCUI 2750198, 2750205UNII W76I6XXF06UPC 0346287085041
- 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
N446287008504followed by a unit qualifier and the quantityPackage 46287-0085-04. 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 .
Indications (excerpt from the label)
QLONILIK TM (clonidine hydrochloride) oral solution is indicated for the treatment of hypertension, to lower blood pressure in adults. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to ach…
Excerpt only. Read the full label for complete information.
About NDC 46287-085
- What is NDC 46287-085?
- 46287-085 is the product NDC for Qlonilik (clonidine hydrochloride), Clonidine hydrochloride .05 mg/mL solution, listed with the FDA by CMP Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Qlonilik (Clonidine hydrochloride).
- What is the active ingredient?
- Clonidine hydrochloride.
- Who is the labeler?
- CMP Pharma, Inc., NDC labeler code 46287. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Qlonilik?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.