Prescription drug · ANDA
Guanfacine NDC 0904-7140
Guanfacine hydrochloride 1 mg/1 · Tablet · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7140-04 | 00904714004 | 30 BLISTER PACK in 1 CARTON (0904-7140-04) / 1 TABLET in 1 BLISTER PACKMarketed from Dec 2, 2013 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Route
- Oral
- Labeler
- Major Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074673
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 0904-7140_eaf671db-1fc7-4923-af07-99aea483d91aSPL ID eaf671db-1fc7-4923-af07-99aea483d91aSPL set ID 400be431-ad6c-4783-a513-ca8b47bf43eeRxCUI 197745UNII 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
N400904714004followed by a unit qualifier and the quantityPackage 00904-7140-04. 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 hydrochloride tablets are indicated in the management of hypertension. Guanfacine 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 074673
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 2 mg/1 | TabletOral | Epic Pharma, LLC | 42806-296 |
| Guanfacine | Guanfacine hydrochloride 1 mg/1 | TabletOral | Proficient Rx LP | 63187-302 |
| Guanfacine | Guanfacine hydrochloride 1 mg/1 | TabletOral | PuraCap Laboratories LLC dba Blu Pharmaceuticals | 24658-730 |
| Guanfacine | Guanfacine hydrochloride 1 mg/1 | TabletOral | Epic Pharma, LLC | 42806-048 |