Prescription drug · ANDA
Guanfacine Hydrochloride (Guanfacine) NDC 50090-6073
Guanfacine hydrochloride 1 mg/1 · Tablet · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-6073-0 | 5009060730050090607300 | 30 TABLET in 1 BOTTLE (50090-6073-0)Marketed from Sep 14, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Active ingredients
- Guanfacine hydrochloride — 1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- A-S Medication SolutionsNDC labeler code 50090
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075109
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 50090-6073_3c848b56-2c4b-488c-a9de-5bce07ed0260SPL ID 3c848b56-2c4b-488c-a9de-5bce07ed0260SPL set ID 9f967d68-5aff-4955-8c79-69febf7c38adRxCUI 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
N450090607300followed by a unit qualifier and the quantityPackage 50090-6073-00. 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 & USAGE Guanfacine 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.
About NDC 50090-6073
- What is NDC 50090-6073?
- 50090-6073 is the product NDC for Guanfacine Hydrochloride (guanfacine), Guanfacine hydrochloride 1 mg/1 tablet, listed with the FDA by A-S Medication Solutions. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Guanfacine Hydrochloride (Guanfacine).
- What is the active ingredient?
- Guanfacine hydrochloride.
- Who is the labeler?
- A-S Medication Solutions, NDC labeler code 50090. 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 Hydrochloride?
- 18 other product NDCs are listed under this name. See all Guanfacine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Guanfacine Hydrochloride 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 Hydrochloride | Guanfacine hydrochloride 1 mg/1 | TabletOral | NORTHSTAR RX LLC | 72603-268 | 72603-0268-01 |
| Guanfacine Hydrochloride | Guanfacine hydrochloride 2 mg/1 | TabletOral | NORTHSTAR RX LLC | 72603-269 | 72603-0269-01 |
| Guanfacine Hydrochloride | Guanfacine hydrochloride 1 mg/1 | TabletOral | XIROMED, LLC | 70700-301 | 70700-0301-0170700-0301-30 |
| Guanfacine Hydrochloride | Guanfacine hydrochloride 2 mg/1 | TabletOral | XIROMED, LLC | 70700-302 | 70700-0302-0170700-0302-0570700-0302-30 |
| Guanfacine Hydrochloride | Guanfacine 1 mg/1 | TabletOral | American Health Packaging | 60687-710 | 60687-0710-21 |
| Guanfacine Hydrochlorideguanfacine | Guanfacine hydrochloride 1 mg/1 | TabletOral | Precision Dose, Inc. | 68094-065 | 68094-0065-62 |
| Guanfacine Hydrochloride | Guanfacine 2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3516 | 70518-3516-00 |
| Guanfacine Hydrochlorideguanfacine | Guanfacine hydrochloride 1 mg/1 | TabletOral | TWi Pharmaceuticals, Inc. | 24979-198 | 24979-0198-01 |
| Guanfacine Hydrochlorideguanfacine | Guanfacine hydrochloride 2 mg/1 | TabletOral | TWi Pharmaceuticals, Inc. | 24979-199 | 24979-0199-01 |
| Guanfacine Hydrochlorideguanfacine | Guanfacine hydrochloride 1 mg/1 | TabletOral | Chartwell RX, LLC | 62135-727 | 62135-0727-90 |
Other NDCs under ANDA 075109
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 Hydrochlorideguanfacine | Guanfacine hydrochloride 2 mg/1 | TabletOral | AvPAK | 50268-374 |
| Guanfacine Hydrochlorideguanfacine | Guanfacine hydrochloride 1 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-711 |
| Guanfacine Hydrochlorideguanfacine | Guanfacine hydrochloride 2 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-713 |
| Guanfacine Hydrochlorideguanfacine | Guanfacine hydrochloride 1 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-711 |
| Guanfacine Hydrochlorideguanfacine | Guanfacine hydrochloride 2 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-713 |
| Guanfacine Hydrochlorideguanfacine | Guanfacine hydrochloride 1 mg/1 | TabletOral | Precision Dose, Inc. | 68094-065 |