Prescription drug · ANDA
Guanfacine Hydrochloride (guanfacine) NDC 62135-727
Guanfacine hydrochloride 1 mg/1 · Tablet · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-727-90 | 62135072790 | 90 TABLET in 1 BOTTLE (62135-727-90)Marketed from Jul 12, 2023 |
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 — 1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Chartwell RX, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216399
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 62135-727_459cdf6c-19fa-c506-e063-6394a90a7393SPL ID 459cdf6c-19fa-c506-e063-6394a90a7393SPL set ID fa7ae501-ee34-4e50-9052-7952e36bbd0eRxCUI 197745, 197746UNII PML56A160OUPC 0362135728908, 0362135727901
- 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
N462135072790followed by a unit qualifier and the quantityPackage 62135-0727-90. 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 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 216399
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 | Chartwell RX, LLC | 62135-728 |
| Guanfacine Hydrochlorideguanfacine | Guanfacine hydrochloride 1 mg/1 | TabletOral | TWi Pharmaceuticals, Inc. | 24979-198 |
| Guanfacine Hydrochlorideguanfacine | Guanfacine hydrochloride 2 mg/1 | TabletOral | TWi Pharmaceuticals, Inc. | 24979-199 |