Prescription drug · ANDA
Guanfacine Hydrochloride NDC 29300-458
Guanfacine 1 mg/1 · Tablet · Oral · Unichem Pharmaceuticals (USA), Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 29300-458-01 | 29300045801 | 100 TABLET in 1 BOTTLE (29300-458-01)Marketed from Apr 5, 2021 |
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 Hydrochloride
- Generic name (nonproprietary)
- guanfacine hydrochloride
- Active ingredients
- Guanfacine — 1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214689
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 29300-458_9df9e7f8-a9b3-4919-94f9-07c81ff7c8b3SPL ID 9df9e7f8-a9b3-4919-94f9-07c81ff7c8b3SPL set ID 14146031-8d56-469b-8de8-fe3cf1712e78RxCUI 197745, 197746UNII 30OMY4G3MK
- 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
N429300045801followed by a unit qualifier and the quantityPackage 29300-0458-01. 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)
INDICATIONS AND USAGE Guanfacine tablets are indicated in the management of hypertension. Guanfacine tablets may be given alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 214689
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 Hydrochloride | Guanfacine 2 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-459 |
| Guanfacine Hydrochloride | Guanfacine 1 mg/1 | TabletOral | American Health Packaging | 60687-710 |
| Guanfacine Hydrochloride | Guanfacine 2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3516 |