Prescription drug · ANDA
Guanfacine NDC 62332-745
Guanfacine hydrochloride 1 mg/1 · Tablet, Extended release · Oral · Alembic Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62332-745-31 | 62332074531 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-745-31)Marketed from Aug 8, 2023 | |
| 62332-745-91 | 62332074591 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-745-91)Marketed from Aug 8, 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
- Generic name (nonproprietary)
- guanfacine
- Active ingredients
- Guanfacine hydrochloride — 1 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Alembic Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217269
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 62332-745_e4b78c34-efde-4552-ae2a-c3ce006bb477SPL ID e4b78c34-efde-4552-ae2a-c3ce006bb477SPL set ID 9db7def2-c6f9-4d7d-a403-fc615358913aRxCUI 862006, 862013, 862019, 862025UNII PML56A160OUPC 0362332748310, 0362332746316, 0362332745319
- 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
N462332074531followed by a unit qualifier and the quantityPackage 62332-0745-31. 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 tablet is 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 217269
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 | 72189-597 |
| Guanfacine | Guanfacine hydrochloride 3 mg/1 | Tablet, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-954 |
| Guanfacine | Guanfacine hydrochloride 4 mg/1 | Tablet, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-955 |
| Guanfacine | Guanfacine hydrochloride 3 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-7644 |
| Guanfacine | Guanfacine hydrochloride 1 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2379 |
| Guanfacine | Guanfacine hydrochloride 2 mg/1 | Tablet, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-953 |
| Guanfacine | Guanfacine hydrochloride 1 mg/1 | Tablet, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-952 |
| Guanfacine | Guanfacine hydrochloride 2 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Inc. | 62332-746 |
| Guanfacine | Guanfacine hydrochloride 3 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Inc. | 62332-747 |
| Guanfacine | Guanfacine hydrochloride 4 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Inc. | 62332-748 |
| Guanfacine | Guanfacine hydrochloride 1 mg/1 | Tablet, Extended releaseOral | St. Mary's Medical Park Pharmacy | 60760-863 |
| Guanfacine | Guanfacine hydrochloride 1 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-745 |
| Guanfacine | Guanfacine hydrochloride 2 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-746 |
| Guanfacine | Guanfacine hydrochloride 3 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-747 |
| Guanfacine | Guanfacine hydrochloride 4 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-748 |