Prescription drug · ANDA
Clonidine Hydrochloride NDC 67046-1000
Clonidine hydrochloride .2 mg/1 · Tablet · Oral · Coupler LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67046-1000-3 | 67046100003 | 30 TABLET in 1 BLISTER PACK (67046-1000-3)Marketed from Nov 8, 2024 |
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 Hydrochloride
- Generic name (nonproprietary)
- clonidine hydrochloride
- Active ingredients
- Clonidine hydrochloride — .2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Coupler LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 070975
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 67046-1000_513d0ac1-12b9-13bb-e063-6294a90ace8bSPL ID 513d0ac1-12b9-13bb-e063-6294a90ace8bSPL set ID 266af0b1-ce85-6699-e063-6394a90acb4dRxCUI 884185UNII 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 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
N467046100003followed by a unit qualifier and the quantityPackage 67046-1000-03. 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)
INDICATIONS AND USAGE Clonidine hydrochloride tablets are indicated in the treatment of hypertension. Clonidine hydrochloride tablets may be employed alone or concomitantly with other antihypertensive agents.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 070975
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 .2 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-024 |
| Clonidine Hydrochloride | Clonidine hydrochloride .2 mg/1 | TabletOral | American Health Packaging | 60687-124 |
| Clonidine Hydrochloride | Clonidine hydrochloride .2 mg/1 | TabletOral | Actavis Pharma, Inc. | 0228-2128 |
| Clonidine Hydrochloride | Clonidine hydrochloride .2 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8272 |
| Clonidine Hydrochloride | Clonidine hydrochloride .2 mg/1 | TabletOral | BluePoint Laboratories | 68001-238 |
| Clonidine Hydrochloride | Clonidine hydrochloride .2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4357 |
| Clonidine Hydrochloride | Clonidine hydrochloride .2 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-362 |
| Clonidine Hydrochloride | Clonidine hydrochloride .2 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-2577 |