Prescription drug · ANDA
Guanfacine Hydrochloride (guanfacine) NDC 65162-713
Guanfacine hydrochloride 2 mg/1 · Tablet · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-713-03 | 65162071303 | 30 TABLET in 1 BOTTLE (65162-713-03)Marketed from Nov 25, 1998 | |
| 65162-713-10 | 65162071310 | 100 TABLET in 1 BOTTLE (65162-713-10)Marketed from Nov 25, 1998 | |
| 65162-713-50 | 65162071350 | 500 TABLET in 1 BOTTLE (65162-713-50)Marketed from Nov 25, 1998 |
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)
- Guanfacine Hydrochloride
- Generic name (nonproprietary)
- guanfacine
- Active ingredients
- Guanfacine hydrochloride — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075109
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 65162-713_2742ab0e-0dcc-4be7-8356-ea7ba8dfe6a7SPL ID 2742ab0e-0dcc-4be7-8356-ea7ba8dfe6a7SPL set ID d9fdc4b4-5b00-46dd-8700-6e36ceaafb0eRxCUI 197745, 197746UNII PML56A160OUPC 0365162713039, 0365162711035
- 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
N465162071303followed by a unit qualifier and the quantityPackage 65162-0713-03. 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 & USAGE Guanfacine tablets, USP are indicated in the management of hypertension. Guanfacine may be given alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075109
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 |
|---|---|---|---|---|
| Guanfacine Hydrochlorideguanfacine | Guanfacine hydrochloride 2 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-713 |
| Guanfacine Hydrochlorideguanfacine | Guanfacine hydrochloride 2 mg/1 | TabletOral | AvPAK | 50268-374 |
| Guanfacine Hydrochlorideguanfacine | Guanfacine hydrochloride 1 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-711 |
| Guanfacine Hydrochlorideguanfacine | Guanfacine hydrochloride 1 mg/1 | TabletOral | A-S Medication Solutions | 50090-6073 |
| Guanfacine Hydrochlorideguanfacine | Guanfacine hydrochloride 1 mg/1 | TabletOral | Precision Dose, Inc. | 68094-065 |
| Guanfacine Hydrochlorideguanfacine | Guanfacine hydrochloride 1 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-711 |