Prescription drug · ANDA
Guanfacine Hydrochloride NDC 70700-302
Guanfacine hydrochloride 2 mg/1 · Tablet · Oral · XIROMED, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70700-302-01 | 70700030201 | 100 TABLET in 1 BOTTLE (70700-302-01)Marketed from Feb 24, 2024 | |
| 70700-302-05 | 70700030205 | 500 TABLET in 1 BOTTLE (70700-302-05)Marketed from Feb 24, 2024 | |
| 70700-302-30 | 70700030230 | 30 TABLET in 1 BOTTLE (70700-302-30)Marketed from Feb 24, 2024 |
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 hydrochloride — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- XIROMED, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218326
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 70700-302_23ee7a86-0dc4-c845-93ff-f02aab00ce8fSPL ID 23ee7a86-0dc4-c845-93ff-f02aab00ce8fSPL set ID 4f1e668a-37dd-44f4-ae99-3a1f6dba3eeaRxCUI 197745, 197746UNII PML56A160OUPC 0370700302057, 0370700301012, 0370700302309, 0370700301302, 0370700302019
- 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
N470700030201followed by a unit qualifier and the quantityPackage 70700-0302-01. 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 AND 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.
Other NDCs under ANDA 218326
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 hydrochloride 1 mg/1 | TabletOral | NORTHSTAR RX LLC | 72603-268 |
| Guanfacine Hydrochloride | Guanfacine hydrochloride 2 mg/1 | TabletOral | NORTHSTAR RX LLC | 72603-269 |
| Guanfacine Hydrochloride | Guanfacine hydrochloride 1 mg/1 | TabletOral | XIROMED, LLC | 70700-301 |