Prescription drug · ANDA
Guanfacine NDC 72888-124
Guanfacine hydrochloride 2 mg/1 · Tablet · Oral · Advagen Pharma Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72888-124-00 | 7288801240072888012400 | 1000 TABLET in 1 BOTTLE (72888-124-00)Marketed from Oct 1, 2021 | |
| 72888-124-01 | 7288801240172888012401 | 100 TABLET in 1 BOTTLE (72888-124-01)Marketed from Oct 1, 2021 | |
| 72888-124-05 | 7288801240572888012405 | 500 TABLET in 1 BOTTLE (72888-124-05)Marketed from Oct 1, 2021 | |
| 72888-124-30 | 7288801243072888012430 | 30 TABLET in 1 BOTTLE (72888-124-30)Marketed from Oct 1, 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
- Generic name (nonproprietary)
- guanfacine
- Active ingredients
- Guanfacine hydrochloride — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Advagen Pharma LtdNDC labeler code 72888
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216762
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 72888-124_473ce2a5-25a3-811b-e063-6294a90a0456SPL ID 473ce2a5-25a3-811b-e063-6294a90a0456SPL set ID 87e1ad56-a7b9-431d-a5d2-d52fb64735c7RxCUI 197745, 197746UNII PML56A160OUPC 0372888124018, 0372888123059, 0372888124308, 0372888123301, 0372888123011, 0372888124001, 0372888124056, 0372888123004
- 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
N472888012400followed by a unit qualifier and the quantityPackage 72888-0124-00. 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.
About NDC 72888-124
- What is NDC 72888-124?
- 72888-124 is the product NDC for Guanfacine, Guanfacine hydrochloride 2 mg/1 tablet, listed with the FDA by Advagen Pharma Ltd. It has 4 package NDCs, 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?
- Advagen Pharma Ltd, NDC labeler code 72888. 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 216762
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 1 mg/1 | TabletOral | Advagen Pharma Ltd | 72888-123 |