Prescription drug · ANDA
Guanfacine NDC 67046-1655
Guanfacine hydrochloride 2 mg/1 · Tablet · Oral · Coupler LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67046-1655-3 | 67046165503 | 30 TABLET in 1 BLISTER PACK (67046-1655-3)Marketed from Jan 28, 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)
- guanfacine
- Active ingredients
- Guanfacine hydrochloride — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Coupler LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217293
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 67046-1655_4973ca2b-3a76-d8d0-e063-6394a90a9d0eSPL ID 4973ca2b-3a76-d8d0-e063-6394a90a9d0eSPL set ID 4973deb3-57ec-1ef3-e063-6294a90aa035RxCUI 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
N467046165503followed by a unit qualifier and the quantityPackage 67046-1655-03. 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 AND USAGE Guanfacine tablets, USP are indicated in the management of hypertension. Guanfacine tablets, USP 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 217293
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 | Coupler LLC | 67046-1433 |
| Guanfacine | Guanfacine hydrochloride 2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4488 |
| Guanfacine | Guanfacine hydrochloride 1 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-242 |
| Guanfacine | Guanfacine hydrochloride 2 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-243 |
| Guanfacine | Guanfacine hydrochloride 1 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4333 |