Prescription drug · ANDA
Guanfacine Hydrochloride NDC 60687-710
Guanfacine 1 mg/1 · Tablet · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60687-710-21 | 6068707102160687071021 | 30 BLISTER PACK in 1 CARTON (60687-710-21) / 1 TABLET in 1 BLISTER PACK (60687-710-11)Marketed from Nov 9, 2023 |
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
- Labeler
- American Health PackagingNDC labeler code 60687
- 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 60687-710_20d4dc32-fa9a-d4dd-e063-6394a90a3861SPL ID 20d4dc32-fa9a-d4dd-e063-6394a90a3861SPL set ID c38bf26f-8a98-4baa-9abb-c83f812900a1RxCUI 197745UNII 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
N460687071021followed by a unit qualifier and the quantityPackage 60687-0710-21. 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 60687-710
- What is NDC 60687-710?
- 60687-710 is the product NDC for Guanfacine Hydrochloride, Guanfacine 1 mg/1 tablet, listed with the FDA by American Health Packaging. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Guanfacine Hydrochloride.
- What is the active ingredient?
- Guanfacine.
- Who is the labeler?
- American Health Packaging, NDC labeler code 60687. 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 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 |
| Guanfacine Hydrochlorideguanfacine | Guanfacine hydrochloride 2 mg/1 | TabletOral | Chartwell RX, LLC | 62135-728 | 62135-0728-90 |
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 1 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-458 |
| Guanfacine Hydrochloride | Guanfacine 2 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-459 |
| Guanfacine Hydrochloride | Guanfacine 2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3516 |