Prescription drug · ANDA
Guanfacine (Gaunfacine) NDC 72319-018
Guanfacine hydrochloride 1 mg/1 · Tablet · Oral · i3 Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72319-018-04 | 7231900180472319001804 | 100 TABLET in 1 BOTTLE (72319-018-04)Marketed from Oct 31, 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)
- gaunfacine
- Active ingredients
- Guanfacine hydrochloride — 1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- i3 Pharmaceuticals, LLCNDC labeler code 72319
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216828
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 72319-018_262d9624-c761-8f3d-e063-6394a90a2640SPL ID 262d9624-c761-8f3d-e063-6394a90a2640SPL set ID 387b33dd-829d-4dab-afe4-078fd1559027RxCUI 197745, 197746UNII PML56A160OUPC 0372319019043, 0372319018046
- 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
N472319001804followed by a unit qualifier and the quantityPackage 72319-0018-04. 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 Tablets, USP are indicated in the management of hypertension. Guanfacine hydrochloride 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 72319-018
- What is NDC 72319-018?
- 72319-018 is the product NDC for Guanfacine (gaunfacine), Guanfacine hydrochloride 1 mg/1 tablet, listed with the FDA by i3 Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Guanfacine (Gaunfacine).
- What is the active ingredient?
- Guanfacine hydrochloride.
- Who is the labeler?
- i3 Pharmaceuticals, LLC, NDC labeler code 72319. 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 216828
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 |
|---|---|---|---|---|
| Guanfacinegaunfacine | Guanfacine hydrochloride 2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4564 |
| Guanfacinegaunfacine | Guanfacine hydrochloride 2 mg/1 | TabletOral | i3 Pharmaceuticals, LLC | 72319-019 |
| Guanfacinegaunfacine | Guanfacine hydrochloride 1 mg/1 | TabletOral | A2A Integrated Pharmaceuticals | 73141-018 |
| Guanfacinegaunfacine | Guanfacine hydrochloride 2 mg/1 | TabletOral | A2A Integrated Pharmaceuticals | 73141-019 |