What is NDC 70700-301?

70700-301 is the product NDC for Guanfacine Hydrochloride, Guanfacine hydrochloride 1 mg/1 tablet, listed with the FDA by XIROMED, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

XIROMED, LLC, NDC labeler code 70700. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Guanfacine Hydrochloride NDC 70700-301

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 NDC	11-digit (billing)	Package	Copy
70700-301-01	7070003010170700030101	100 TABLET in 1 BOTTLE (70700-301-01)Marketed from Feb 24, 2024
70700-301-30	7070003013070700030130	30 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
Labeler: XIROMED, LLCNDC labeler code 70700
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218326
Marketing start: Feb 24, 2024
Listing expires: Dec 31, 2026
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 Feb 24, 2024.

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)

About NDC 70700-301

What is NDC 70700-301?: 70700-301 is the product NDC for Guanfacine Hydrochloride, Guanfacine hydrochloride 1 mg/1 tablet, listed with the FDA by XIROMED, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Guanfacine Hydrochloride.
What is the active ingredient?: Guanfacine hydrochloride.
Who is the labeler?: XIROMED, LLC, NDC labeler code 70700. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Guanfacine Hydrochloride NDCs
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 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
Guanfacine Hydrochlorideguanfacine	Guanfacine hydrochloride 2 mg/1	TabletOral	Chartwell RX, LLC	62135-728	62135-0728-90

All 19 Guanfacine Hydrochloride NDCs

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
Product	Strength	Form · route	Labeler	Product NDC
Guanfacine Hydrochloride	Guanfacine hydrochloride 2 mg/1	TabletOral	XIROMED, LLC	70700-302
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