Prescription drug · ANDA

Guanfacine Hydrochloride NDC 70700-301

Guanfacine hydrochloride 1 mg/1 · Tablet · Oral · XIROMED, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)70700-301Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70700-0301Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
70700-301-0170700030101100 TABLET in 1 BOTTLE (70700-301-01)Marketed from Feb 24, 2024
70700-301-307070003013030 TABLET in 1 BOTTLE (70700-301-30)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 — 1 mg/1
Dosage form
Tablet
Route
Oral
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 70700-301_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

N470700030101 followed by a unit qualifier and the quantity

Package 70700-0301-01. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 218326

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 218326
ProductStrengthForm · routeLabelerProduct NDC
Guanfacine HydrochlorideGuanfacine hydrochloride 1 mg/1TabletOralNORTHSTAR RX LLC72603-268
Guanfacine HydrochlorideGuanfacine hydrochloride 2 mg/1TabletOralNORTHSTAR RX LLC72603-269
Guanfacine HydrochlorideGuanfacine hydrochloride 2 mg/1TabletOralXIROMED, LLC70700-302

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Guanfacine Hydrochloride NDC 70700-301 | Med-Code