Prescription drug · ANDA
Guanfacine (gaunfacine) NDC 70518-4564
Guanfacine hydrochloride 2 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4564-0 | 70518456400 | 30 TABLET in 1 BLISTER PACK (70518-4564-0)Marketed from Feb 3, 2026 |
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)
- Guanfacine
- Generic name (nonproprietary)
- gaunfacine
- Active ingredients
- Guanfacine hydrochloride — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216828
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 70518-4564_49ee625b-ae00-dde3-e063-6294a90a87e8SPL ID 49ee625b-ae00-dde3-e063-6294a90a87e8SPL set ID 46dcdeaa-ec2a-48d6-b315-fcc3dd71c5e0RxCUI 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
N470518456400followed by a unit qualifier and the quantityPackage 70518-4564-00. 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 Guanfacine Tablets, USP are indicated in the management of hypertension. Guanfacine hydrochloride 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 216828
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 |
|---|---|---|---|---|
| Guanfacinegaunfacine | Guanfacine hydrochloride 1 mg/1 | TabletOral | A2A Integrated Pharmaceuticals | 73141-018 |
| Guanfacinegaunfacine | Guanfacine hydrochloride 2 mg/1 | TabletOral | A2A Integrated Pharmaceuticals | 73141-019 |
| Guanfacinegaunfacine | Guanfacine hydrochloride 1 mg/1 | TabletOral | i3 Pharmaceuticals, LLC | 72319-018 |
| Guanfacinegaunfacine | Guanfacine hydrochloride 2 mg/1 | TabletOral | i3 Pharmaceuticals, LLC | 72319-019 |