Prescription drug · ANDA
Guanfacine NDC 63629-8161
Guanfacine hydrochloride 1 mg/1 · Tablet, Extended release · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8161-1 | 6362981610163629816101 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-8161-1)Marketed from Jul 2, 2019 |
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 — 1 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205689
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 63629-8161_a56ba9c2-6013-480b-9f1c-66bcc201040cSPL ID a56ba9c2-6013-480b-9f1c-66bcc201040cSPL set ID f070a54a-2738-4ef2-a98a-f9e7a7a56f55RxCUI 862006UNII 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
N463629816101followed by a unit qualifier and the quantityPackage 63629-8161-01. 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, 14).
Excerpt only. Read the full label for complete information.
About NDC 63629-8161
- What is NDC 63629-8161?
- 63629-8161 is the product NDC for Guanfacine, Guanfacine hydrochloride 1 mg/1 tablet, extended release, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Guanfacine.
- What is the active ingredient?
- Guanfacine hydrochloride.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 63629. 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?
- 71 other product NDCs are listed under this name. See all Guanfacine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Guanfacine 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 | Guanfacine hydrochloride 2 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4675 | 70518-4675-00 |
| Guanfacine | Guanfacine hydrochloride 4 mg/1 | Tablet, Extended releaseOral | Fosun Pharma USA, Inc | 72266-258 | 72266-0258-55 |
| Guanfacinegaunfacine | Guanfacine hydrochloride 2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4564 | 70518-4564-00 |
| Guanfacine | Guanfacine hydrochloride 2 mg/1 | TabletOral | Coupler LLC | 67046-1655 | 67046-1655-03 |
| Guanfacine | Guanfacine hydrochloride 1 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4539 | 70518-4539-00 |
| Guanfacine | Guanfacine hydrochloride 1 mg/1 | Tablet, Extended releaseOral | Fosun Pharma USA, Inc | 72266-255 | 72266-0255-55 |
| Guanfacine | Guanfacine hydrochloride 2 mg/1 | Tablet, Extended releaseOral | Fosun Pharma USA, Inc | 72266-256 | 72266-0256-55 |
| Guanfacine | Guanfacine hydrochloride 3 mg/1 | Tablet, Extended releaseOral | Fosun Pharma USA, Inc | 72266-257 | 72266-0257-55 |
| Guanfacine | Guanfacine hydrochloride 2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4488 | 70518-4488-00 |
| Guanfacine | Guanfacine hydrochloride 1 mg/1 | Tablet, Extended releaseOral | St. Mary's Medical Park Pharmacy | 60760-863 | 60760-0863-30 |
Other NDCs under ANDA 205689
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 3 mg/1 | Tablet, Extended releaseOral | NORTHSTAR RXLLC | 16714-192 |
| Guanfacine | Guanfacine hydrochloride 4 mg/1 | Tablet, Extended releaseOral | NORTHSTAR RXLLC | 16714-193 |
| Guanfacine | Guanfacine hydrochloride 1 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-1798 |
| Guanfacine | Guanfacine hydrochloride 2 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-1799 |
| Guanfacine | Guanfacine hydrochloride 4 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-1801 |
| Guanfacine | Guanfacine hydrochloride 2 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 63629-8203 |
| Guanfacine | Guanfacine hydrochloride 2 mg/1 | Tablet, Extended releaseOral | NORTHSTAR RXLLC | 16714-191 |
| Guanfacine | Guanfacine hydrochloride 1 mg/1 | Tablet, Extended releaseOral | NORTHSTAR RXLLC | 16714-190 |