Prescription drug · NDA
Nexiclon XR (Clonidine) NDC 71511-503
Clonidine .17 mg/1 · Tablet, Extended release · Oral · Rosemont Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71511-503-30 | 7151105033071511050330 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71511-503-30)Marketed from Mar 1, 2022 |
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)
- Nexiclon XR
- Generic name (nonproprietary)
- clonidine
- Active ingredients
- Clonidine — .17 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Rosemont Pharmaceuticals LLCNDC labeler code 71511
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022500
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 71511-503_4f83c93a-721f-ca2f-e063-6394a90aa789SPL ID 4f83c93a-721f-ca2f-e063-6394a90aa789SPL set ID dad35a6f-d57e-f302-e053-2995a90a9efbRxCUI 885880, 1050338UNII MN3L5RMN02
- 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
N471511050330followed by a unit qualifier and the quantityPackage 71511-0503-30. 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)
NEXICLON XR is indicated in the treatment of hypertension. NEXICLON XR may be employed alone or concomitantly with other antihypertensive agents. NEXICLON XR is a central alpha-adrenergic agonist indicated for: Treatment of hypertension ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 71511-503
- What is NDC 71511-503?
- 71511-503 is the product NDC for Nexiclon XR (clonidine), Clonidine .17 mg/1 tablet, extended release, listed with the FDA by Rosemont Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nexiclon XR (Clonidine).
- What is the active ingredient?
- Clonidine.
- Who is the labeler?
- Rosemont Pharmaceuticals LLC, NDC labeler code 71511. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nexiclon XR?
- 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.
Other NDCs under NDA 022500
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Clonidine | Clonidine .17 mg/1 | Tablet, Extended releaseOral | TruPharma, LLC | 52817-375 |
| Clonidine | Clonidine .17 mg/1 | Tablet, Extended releaseOral | PALMETTO PHARMACEUTICALS INC. | 68134-603 |