Prescription drug · ANDA
Guanfacine NDC 70436-039
Guanfacine hydrochloride 1 mg/1 · Tablet, Extended release · Oral · Slate Run Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70436-039-01 | 70436003901 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70436-039-01)Marketed from Aug 1, 2022 |
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
- Generic name (nonproprietary)
- guanfacine
- Active ingredients
- Guanfacine hydrochloride — 1 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213428
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 70436-039_44e07739-2e64-f744-e063-6394a90ab3acSPL ID 44e07739-2e64-f744-e063-6394a90ab3acSPL set ID ed65ca51-b9b0-43b9-9826-03a7be256a2aRxCUI 862006, 862013, 862019, 862025UNII PML56A160OUPC 0370436039012, 0370436042012, 0370436041015, 0370436040018
- 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
N470436003901followed by a unit qualifier and the quantityPackage 70436-0039-01. 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.
Other NDCs under ANDA 213428
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 | Slate Run Pharmaceuticals, LLC | 70436-041 |
| Guanfacine | Guanfacine hydrochloride 2 mg/1 | Tablet, Extended releaseOral | Slate Run Pharmaceuticals, LLC | 70436-040 |
| Guanfacine | Guanfacine hydrochloride 4 mg/1 | Tablet, Extended releaseOral | Slate Run Pharmaceuticals, LLC | 70436-042 |
| Guanfacine | Guanfacine hydrochloride 3 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-7129 |