Prescription drug · ANDA
Guanfacine NDC 42806-296
Guanfacine hydrochloride 2 mg/1 · Tablet · Oral · Epic Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42806-296-01 | 42806029601 | 100 TABLET in 1 BOTTLE (42806-296-01)Marketed from May 30, 2019 |
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
- Generic name (nonproprietary)
- guanfacine
- Active ingredients
- Guanfacine hydrochloride — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Epic Pharma, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074673
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 42806-296_d0ca35de-12e8-4154-825a-c82eed36efd7SPL ID d0ca35de-12e8-4154-825a-c82eed36efd7SPL set ID fac4a4c2-f5f0-46ef-b76b-315abe9136faRxCUI 197745, 197746UNII PML56A160O
- 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
N442806029601followed by a unit qualifier and the quantityPackage 42806-0296-01. 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 Guanfacine hydrochloride tablets 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 074673
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 | Guanfacine hydrochloride 1 mg/1 | TabletOral | Proficient Rx LP | 63187-302 |
| Guanfacine | Guanfacine hydrochloride 1 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7140 |
| Guanfacine | Guanfacine hydrochloride 1 mg/1 | TabletOral | PuraCap Laboratories LLC dba Blu Pharmaceuticals | 24658-730 |
| Guanfacine | Guanfacine hydrochloride 1 mg/1 | TabletOral | Epic Pharma, LLC | 42806-048 |