Prescription drug · ANDA
Clonidine hydrochloride NDC 52817-182
Clonidine hydrochloride .3 mg/1 · Tablet · Oral · TruPharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52817-182-00 | 52817018200 | 1000 TABLET in 1 BOTTLE (52817-182-00)Marketed from Jun 1, 2017 | |
| 52817-182-10 | 52817018210 | 100 TABLET in 1 BOTTLE (52817-182-10)Marketed from Jun 1, 2017 | |
| 52817-182-50 | 52817018250 | 500 TABLET in 1 BOTTLE (52817-182-50)Marketed from Jun 1, 2017 |
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 — .3 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- TruPharma, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 070923
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 52817-182_50b257d2-56a5-412b-e063-6394a90acae1SPL ID 50b257d2-56a5-412b-e063-6394a90acae1SPL set ID c83e4e4f-bd0e-449d-958a-dc0d570a01baRxCUI 884173, 884185, 884189, 2740803UNII W76I6XXF06UPC 0352817181107, 0352817183101, 0352817182005, 0352817182104
- 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
N452817018200followed by a unit qualifier and the quantityPackage 52817-0182-00. 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 USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets USP may be employed alone or concomitantly with other antihypertensive agents.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 070923
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 | TabletOral | Unit Dose Solutions, Inc. | 87441-023 |
| Clonidine hydrochloride | Clonidine hydrochloride .3 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-286 |
| Clonidine hydrochloride | Clonidine hydrochloride .1 mg/1 | TabletOral | TruPharma, LLC | 52817-180 |
| Clonidine hydrochloride | Clonidine hydrochloride .2 mg/1 | TabletOral | TruPharma, LLC | 52817-181 |
| Clonidine hydrochloride | Clonidine hydrochloride .05 mg/1 | TabletOral | TruPharma, LLC | 52817-183 |
| Clonidine hydrochloride | Clonidine hydrochloride .3 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1624 |
| Clonidine hydrochloride | Clonidine hydrochloride .3 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-449 |
| Clonidine hydrochloride | Clonidine hydrochloride .3 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-451 |