Prescription drug · ANDA
Clonidine hydrochloride NDC 68001-568
Clonidine hydrochloride .1 mg/1 · Tablet, Extended release · Oral · BluePoint Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68001-568-06 | 6800105680668001056806 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-568-06)Marketed from Aug 24, 2023 |
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
- BluePoint LaboratoriesNDC labeler code 68001
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209686
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 68001-568_3c4f16d2-af44-ddf6-e063-6294a90aae36SPL ID 3c4f16d2-af44-ddf6-e063-6294a90aae36SPL set ID f34ae077-4ace-4e0a-bc87-d559b1c5bf2fRxCUI 1013930UNII W76I6XXF06UPC 0368001568067
- 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
N468001056806followed by a unit qualifier and the quantityPackage 68001-0568-06. 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)
Clonidine hydrochloride extended-release is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications [see Clinical 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.
About NDC 68001-568
- What is NDC 68001-568?
- 68001-568 is the product NDC for Clonidine hydrochloride, Clonidine hydrochloride .1 mg/1 tablet, extended release, listed with the FDA by BluePoint Laboratories. 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?
- BluePoint Laboratories, NDC labeler code 68001. 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.
Related NDCs: other Clonidine hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 |
Other NDCs under ANDA 209686
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 hydrochloride | Clonidine hydrochloride .1 mg/1 | Tablet, Extended releaseOral | Ajanta Pharma USA Inc. | 27241-108 |
| Clonidine hydrochloride | Clonidine hydrochloride .1 mg/1 | Tablet, Extended releaseOral | American Health Packaging | 60687-462 |