Prescription drug · ANDA
Guanfacine extended-release (Guanfacine) NDC 60505-3929
Guanfacine hydrochloride 3 mg/1 · Tablet, Extended release · Oral · Apotex Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-3929-1 | 6050539290160505392901 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-3929-1)Marketed from Oct 3, 2018 |
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
- Apotex Corp.NDC labeler code 60505
- 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 60505-3929_be71bf36-161d-d944-6044-1bbe8d133d28SPL ID be71bf36-161d-d944-6044-1bbe8d133d28SPL set ID 1c492e87-3406-ddb8-aaf2-e609c2ded503RxCUI 862006, 862013, 862019, 862025UNII 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
N460505392901followed by a unit qualifier and the quantityPackage 60505-3929-01. 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)
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.
About NDC 60505-3929
- What is NDC 60505-3929?
- 60505-3929 is the product NDC for Guanfacine extended-release (guanfacine), Guanfacine hydrochloride 3 mg/1 tablet, extended release, listed with the FDA by Apotex Corp.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Guanfacine extended-release (Guanfacine).
- What is the active ingredient?
- Guanfacine hydrochloride.
- Who is the labeler?
- Apotex Corp., NDC labeler code 60505. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Guanfacine extended-release?
- 22 other product NDCs are listed under this name. See all Guanfacine extended-release NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Guanfacine extended-release products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Guanfacine extended-releaseguanfacine | Guanfacine hydrochloride 2 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4266 | 70518-4266-00 |
| Guanfacine Extended-Releaseguanfacine | Guanfacine 2 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-3809 | 70518-3809-00 |
| Guanfacine Extended-Releaseguanfacine | Guanfacine 1 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-2771 | 70518-2771-0070518-2771-01 |
| Guanfacine extended-releaseguanfacine | Guanfacine hydrochloride 3 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-6493 | 50090-6493-00 |
| Guanfacine extended-releaseguanfacine | Guanfacine hydrochloride 1 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-3078 | 71335-3078-01 |
| Guanfacine extended-releaseguanfacine | Guanfacine hydrochloride 2 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2852 | 71335-2852-01 |
| Guanfacine extended-releaseguanfacine | Guanfacine hydrochloride 2 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-9750 | 71335-9750-0171335-9750-02 |
| Guanfacine extended-releaseguanfacine | Guanfacine hydrochloride 4 mg/1 | Tablet, Extended releaseOral | Apotex Corp. | 60505-3930 | 60505-3930-01 |
| Guanfacine extended-releaseguanfacine | Guanfacine hydrochloride 1 mg/1 | Tablet, Extended releaseOral | Apotex Corp. | 60505-3927 | 60505-3927-01 |
| Guanfacine extended-releaseguanfacine | Guanfacine hydrochloride 2 mg/1 | Tablet, Extended releaseOral | Apotex Corp. | 60505-3928 | 60505-3928-01 |
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 ER | Guanfacine hydrochloride 1 mg/1 | Tablet, Extended releaseOral | Direct_Rx | 72189-469 |
| Guanfacine extended-releaseguanfacine | Guanfacine hydrochloride 3 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-6493 |
| 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 2 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4266 |
| Guanfacine extended-releaseguanfacine | Guanfacine hydrochloride 2 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2852 |
| Guanfacine extended-releaseguanfacine | Guanfacine hydrochloride 4 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-3005 |
| Guanfacine extended-releaseguanfacine | Guanfacine hydrochloride 1 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-3078 |
| Guanfacine extended-releaseguanfacine | Guanfacine hydrochloride 2 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-9750 |