Prescription drug · ANDA
Guanfacine extended-release (guanfacine) NDC 50090-6493
Guanfacine hydrochloride 3 mg/1 · Tablet, Extended release · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-6493-0 | 50090649300 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6493-0)Marketed from May 22, 2023 |
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 extended-release
- Generic name (nonproprietary)
- guanfacine
- Active ingredients
- Guanfacine hydrochloride — 3 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205430
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 50090-6493_22450f1d-9d74-467c-96a8-a8a3d6a59e68SPL ID 22450f1d-9d74-467c-96a8-a8a3d6a59e68SPL set ID 07797c4a-a799-436b-a77c-a2861a811a99RxCUI 862019UNII 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
N450090649300followed by a unit qualifier and the quantityPackage 50090-6493-00. 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)
Guanfacine extended-release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications [see Clinical Studies (14 )] . Guanfacine extended-release tablets are a central alpha 2A -adrenergic receptor agonist indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications ( 1 , 1 4 ).
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205430
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 extended-releaseguanfacine | Guanfacine hydrochloride 2 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-9750 |
| Guanfacine extended-releaseguanfacine | Guanfacine hydrochloride 2 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2852 |
| Guanfacine extended-releaseguanfacine | Guanfacine hydrochloride 2 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4266 |
| Guanfacine ER | Guanfacine hydrochloride 1 mg/1 | Tablet, Extended releaseOral | Direct_Rx | 72189-469 |
| Guanfacine extended-releaseguanfacine | Guanfacine hydrochloride 3 mg/1 | Tablet, Extended releaseOral | Apotex Corp. | 60505-3929 |
| Guanfacine extended-releaseguanfacine | Guanfacine hydrochloride 1 mg/1 | Tablet, Extended releaseOral | Apotex Corp. | 60505-3927 |
| Guanfacine extended-releaseguanfacine | Guanfacine hydrochloride 2 mg/1 | Tablet, Extended releaseOral | Apotex Corp. | 60505-3928 |
| Guanfacine extended-releaseguanfacine | Guanfacine hydrochloride 4 mg/1 | Tablet, Extended releaseOral | Apotex Corp. | 60505-3930 |
| Guanfacine extended-releaseguanfacine | Guanfacine hydrochloride 1 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-3078 |
| Guanfacine extended-releaseguanfacine | Guanfacine hydrochloride 4 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-3005 |