Prescription drug · ANDA
Clonidine Hydrochloride NDC 72162-1367
Clonidine hydrochloride .1 mg/1 · Tablet, Extended release · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-1367-6 | 72162136706 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-1367-6)Marketed from Jul 16, 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 — .1 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209757
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 72162-1367_2c7b0581-f1a8-45ae-97ea-8cb4bf6b7403SPL ID 2c7b0581-f1a8-45ae-97ea-8cb4bf6b7403SPL set ID 36bd0f0e-5569-466a-ab1b-90eb39efdd68RxCUI 1013930UNII 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
N472162136706followed by a unit qualifier and the quantityPackage 72162-1367-06. 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 tablets 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 is a centrally acting alpha2-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.
Other NDCs under ANDA 209757
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 | Solco Healthcare LLC | 43547-435 |
| Clonidine Hydrochloride | Clonidine hydrochloride .1 mg/1 | Tablet, Extended releaseOral | Xiamen LP Pharmaceutical Co., Ltd. | 71034-001 |