Prescription drug · ANDA
Guanfacine Hydrochloride (Guanfacine) NDC 24979-198
Guanfacine hydrochloride 1 mg/1 · Tablet · Oral · TWi Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 24979-198-01 | 2497901980124979019801 | 100 TABLET in 1 BOTTLE (24979-198-01)Marketed from Sep 1, 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 Hydrochloride
- Generic name (nonproprietary)
- guanfacine
- Active ingredients
- Guanfacine hydrochloride — 1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- TWi Pharmaceuticals, Inc.NDC labeler code 24979
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216399
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 24979-198_ef3592ef-2184-43de-9f37-062bd24079d6SPL ID ef3592ef-2184-43de-9f37-062bd24079d6SPL set ID a0c2d95d-805c-4c7d-9733-52073a65218aRxCUI 197745, 197746UNII PML56A160OUPC 0324979199016, 0324979198019
- 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
N424979019801followed by a unit qualifier and the quantityPackage 24979-0198-01. 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, USP 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 24979-198
- What is NDC 24979-198?
- 24979-198 is the product NDC for Guanfacine Hydrochloride (guanfacine), Guanfacine hydrochloride 1 mg/1 tablet, listed with the FDA by TWi Pharmaceuticals, Inc.. 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?
- TWi Pharmaceuticals, Inc., NDC labeler code 24979. 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 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 216399
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 | TWi Pharmaceuticals, Inc. | 24979-199 |
| Guanfacine Hydrochlorideguanfacine | Guanfacine hydrochloride 1 mg/1 | TabletOral | Chartwell RX, LLC | 62135-727 |
| Guanfacine Hydrochlorideguanfacine | Guanfacine hydrochloride 2 mg/1 | TabletOral | Chartwell RX, LLC | 62135-728 |