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Guanfacine Hydrochloride 1 mg Tablet, 30-count — NDC 70700-0301-30 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Guanfacine Hydrochloride 1 mg Tablet, 30-count — NDC 70700-301-30 (Billing 70700-0301-30)

by XIROMED, LLC · 30 TABLET in 1 BOTTLE

This is a package of 30 tablets of Guanfacine Hydrochloride 1 mg Tablet from XIROMED, LLC, marketed since Feb 2024 and currently FDA-listed.

NDC 70700-0301-30
🏷️ FDA NDC (as labeled) 70700-301-30 billing pads the product segment with a zero
This package
Contains30-count Pack sizes2 compare ↓
Product page 70700-0301-01 Also comes in: 100 tablets 70700-301-01
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70700-301-30
Product NDC 70700-301
11-digit billing NDC 70700030130
RxCUI 197745, 197746
UNII PML56A160O
UPC 0370700302057, 0370700301012, 0370700302309, 0370700301302 +1 more
Application # ANDA218326
SPL Set ID 4f1e668a-37dd-44f4-ae99-3a1f6dba3eea
Established class (EPC) Central alpha-2 Adrenergic Agonist
Mechanism of action Adrenergic alpha2-Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-02-24
Route ORAL
Dosage form TABLET
Substance GUANFACINE HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 36201025100320
GCN Seq No 000364
GCN 32480
HICL code 000120
Ingredient (HICL) Guanfacine Hcl
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A4
Therapeutic class — intermediate (HIC2) Antihypertensives
HIC3 code A4B
Therapeutic class — specific (HIC3) Antihypertensives, Sympatholytic
AHFS code 24:24.00.00
AHFS class Central Alpha-Agonists
FDB label name GUANFACINE 1 MG TABLET
FDB brand name Guanfacine Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 000364
  • GCN: 32480
  • GPI-14 (Medi-Span): 36201025100320
  • HICL (First Databank): 000120
  • AHFS class code: 24:24.00.00
  • RxCUI (RxNorm): 197745
Why two NDCs? The FDA registers this code as 70700-301-30 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 70700-0301-30. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Central alpha-2 Adrenergic Agonist class.

Pharmacologic class Central alpha-2 Adrenergic Agonist
Drug family (ATC) Imidazoline receptor agonists
How it works Adrenergic alpha2-Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name GUANFACINE 1 MG TABLET Ingredient Guanfacine Hcl
📗 Our plain-language guide HelloPharmacist
  • It's used for both, depending on which form you have. The regular (immediate-release) tablet is prescribed for high blood pressure. The extended-release version — brand name Intuni...
  • What is guanfacine actually used for — is it for ADHD or blood pressure?
  • No, Intuniv is not a stimulant at all. It works on a different part of the brain than medications like Adderall or Ritalin. That's actually one reason it's sometimes used alongside...
  • My child takes Intuniv for ADHD — is it a stimulant?
📖 Read our full Guanfacine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
1
Nutrient depletion considerations

Guanfacine may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Guanfacine nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 100 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
70700-0301-01 70700-301-01 Main listing 100 TABLET in 1 BOTTLE $0.1466 / ea $14.66 2024-02-24 — Active
70700-0301-30 You're viewing this 30 TABLET in 1 BOTTLE — — 2024-02-24 — Active

You're viewing the smallest of 2 pack sizes for this product.

This pack shows little to no recent Medicaid volume — the 100 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 30-count package — 30 tablet in 1 bottle.
How does this package differ from NDC 70700-0301-01?
Both are Guanfacine Hydrochloride 1 mg Tablet — the drug itself is identical. This page's package is the 30-count one, while NDC 70700-0301-01 is the 100 tablets package.
What NDC number is used to bill for this package of Guanfacine Hydrochloride 1 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Guanfacine 1 mg 00591-0444-01 Actavis 100 tablets $0.147 — Availability likely —
Guanfacine 1 mg 00904-7140-04 Major 30 tablets $0.147 AB Availability likely —
Guanfacine Hydrochloride 1 mg 24979-0198-01 TWi 100 tablets $0.147 AB Availability likely —
Guanfacine 1 mg 27241-0242-01 Ajanta 100 tablets $0.147 AB Availability likely —
Guanfacine Hydrochloride 1 mg 29300-0458-01 Unichem 100 tablets $0.147 AB Availability likely —
Guanfacine 1 mg 42806-0048-01 Epic 100 tablets $0.147 AB Availability likely —
Guanfacine Hydrochloride 1 mg 53746-0711-01 Amneal 100 tablets $0.147 AB Availability likely —
Guanfacine 1 mg 59651-0840-01 Aurobindo 100 tablets $0.147 AB Availability likely —
Guanfacine Hydrochloride 1 mg 60687-0710-21 American 30 tablets $0.147 AB Availability likely —
Guanfacine Hydrochloride 1 mg 62135-0727-90 Chartwell 90 tablets $0.147 AB Availability likely —
Guanfacine Hydrochloride 1 mg 68094-0065-62 Precision 30 tablets $0.147 AB Availability likely —
Guanfacine 1 mg 72319-0018-04 i3 100 tablets $0.147 AB Availability likely —
Guanfacine 1 mg 24658-0730-01 PuraCap 100 tablets — AB FDA listed —
Guanfacine Hydrochloride 1 mg 50090-6073-00 A-S 30 tablets — AB FDA listed —
Guanfacine 1 mg 63187-0302-30 Proficient 30 tablets — AB FDA listed —
Guanfacine Hydrochloride 1 mg 65162-0711-03 Amneal 30 tablets — AB FDA listed —
Guanfacine 1 mg 67046-1433-03 Coupler 30 tablets — AB FDA listed —
Guanfacine 1 mg 70518-4333-00 REMEDYREPACK 30 tablets — AB FDA listed —
Guanfacine Hydrochloride 1 mgthis 70700-0301-30 XIROMED, 30 tablets — AB FDA listed —
Guanfacine Hydrochloride 1 mg 72603-0268-01 NORTHSTAR 100 tablets — AB FDA listed —
Guanfacine 1 mg 72888-0123-00 Advagen 1000 tablets — AB FDA listed —
Guanfacine 1 mg 73141-0018-04 A2A 100 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2024
On the market since
Feb 2024
📍
2026
Currently FDA-listed
2 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color white
ShapeOval
ImprintXI;131
Size11 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerXIROMED, LLC
Application holderXIROMED PHARMA ESPANA SL
FDA applicationANDA218326 (ANDA)
Labeler code70700
First marketedFeb 2024
Product typeHuman Prescription Drug
Portfolio42 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 27 words ▾

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.

⏱️ Dosage and Administration 147 words ▾

DOSAGE AND ADMINISTRATION The recommended initial dose of guanfacine tablets when given alone or in combination with another antihypertensive drug is 1 mg daily given at bedtime to minimize somnolence. If after 3 to 4 weeks of therapy 1 mg does not give a satisfactory result, a dose of 2 mg may be given, although most of the effect of guanfacine is seen at 1 mg (see CLINICAL PHARMACOLOGY ). Higher daily doses have been used, but adverse reactions increase significantly with doses above 3 mg/day.

The frequency of rebound hypertension is low, but it can occur. When rebound occurs, it does so after 2 - 4 days, which is delayed compared with clonidine hydrochloride. This is consistent with the longer half-life of guanfacine.

In most cases, after abrupt withdrawal of guanfacine, blood pressure returns to pretreatment levels slowly (within 2 - 4 days) without ill effects.

⛔ Contraindications 13 words ▾

CONTRAINDICATIONS Guanfacine tablets are contraindicated in patients with known hypersensitivity to guanfacine hydrochloride.

🤒 Adverse Reactions ~3 min read ▾

ADVERSE REACTIONS Adverse reactions noted with guanfacine hydrochloride are similar to those of other drugs of the central α 2 -adrenoreceptor agonist class: dry mouth, sedation (somnolence), weakness (asthenia), dizziness, constipation, and impotence. While the reactions are common, most are mild and tend to disappear on continued dosing. Skin rash with exfoliation has been reported in a few cases; although clear cause and effect relationships to guanfacine could not be established, should a rash occur, guanfacine should be discontinued and the patient monitored appropriately.

In the dose-response monotherapy study described under CLINICAL PHARMACOLOGY , the frequency of the most commonly observed adverse reactions showed a dose relationship from 0.5 to 3 mg as follows: Adverse Reaction Placebo n=59 0.5 mg n=60 1 mg n=61 2 mg n=60 3 mg n=59 Dry Mouth 0% 10% 10% 42% 54% Somnolence 8% 5% 10% 13% 39% Asthenia 0% 2% 3% 7% 3% Dizziness 8% 12% 2% 8% 15% Headache 8% 13% 7% 5% 3% Impotence 0% 0% 0% 7% 3% Constipation 0% 2% 0% 5% 15% Fatigue 2% 2% 5% 8% 10% The percent of patients who dropped out because of adverse reactions are shown below for each dosage group.

Placebo 0.5 mg 1 mg 2 mg 3 mg Percent dropouts 0% 2% 5% 13% 32% The most common reasons for dropouts among patients who received guanfacine were dry mouth, somnolence, dizziness, fatigue, weakness, and constipation. In the 12-week, placebo-controlled, dose-response study of guanfacine administered with 25 mg chlorthalidone at bedtime, the frequency of the most commonly observed adverse reactions showed a clear dose relationship from 0.5 to 3 mg as follows: Adverse Reactions Placebo n=73 0.5 mg n=72 1 mg n=72 2 mg n=72 3 mg n=72 Dry Mouth 5 (7%) 4 (5%) 6 (8%) 8 (11%) 20 (28%) Somnolence 1 (1%) 3 (4%) 0 (0%) 1 (1%) 10 (14%) Asthenia 0 (0%) 2 (3%) 0 (0%) 2 (2%) 7 (10%) Dizziness 2 (2%) 1 (1%) 3 (4%) 6 (8%) 3 (4%) Headache 3 (4%) 4 (3%) 3 (4%) 1 (1%) 2 (2%) Impotence 1 (1%) 1 (0%) 0 (0%) 1 (1%) 3 (4%) Constipation 0 (0%) 0 (0%) 0 (0%) 1 (1%) 1 (1%) Fatigue 3 (3%) 2 (3%) 2 (3%) 5 (6%) 3 (4%) There were 41 premature terminations because of adverse reactions in this study.

The percent of patients who dropped out and the dose at which the dropout occurred were as follows: Dose Placebo 0.5 mg 1 mg 2 mg 3 mg Percent dropouts 6.9% 4.2% 3.2% 6.9% 8.3% Reasons for dropouts among patients who received guanfacine were: somnolence, headache, weakness, dry mouth, dizziness, impotence, insomnia, constipation, syncope, urinary incontinence, conjunctivitis, paresthesia, and dermatitis. In a second 12-week placebo-controlled combination therapy study in which the dose could be adjusted upward to 3 mg per day in 1-mg increments at 3-week intervals, i.e., a setting more similar to ordinary clinical use, the most commonly recorded reactions were: dry mouth, 47%; constipation, 16%; fatigue, 12%; somnolence, 10%; asthenia, 6%; dizziness, 6%; headache, 4%; and insomnia, 4%.

Reasons for dropouts among patients who received guanfacine were: somnolence, dry mouth, dizziness, impotence, constipation, confusion, depression, and palpitations. In the clonidine/guanfacine comparison described in CLINICAL PHARMACOLOGY , the most common adverse reactions noted were as follows: Adverse Reactions Guanfacine (n=279) Clonidine (n=278) Dry Mouth 30% 37% Somnolence 21% 35% Dizziness 11% 8% Constipation 10% 5% Fatigue 9% 8% Headache 4% 4% Insomnia 4% 3% Adverse reactions occurring in 3% or less of patients in the three controlled trials of guanfacine hydrochloride with a diuretic were: Cardiovascular- bradycardia, palpitations, substernal pain Gastrointestinal- abdominal pain, diarrhea, dyspepsia, dysphagia, nausea CNS- amnesia, confusion, depression, insomnia, libido decrease ENT disorders- rhinitis, taste perversion, tinnitus Eye disorders- conjunctivitis, iritis, vision disturbance Musculoskeletal- leg cramps, hypokinesia Respiratory- dyspnea Dermatologic- dermatitis, pruritus, purpura, sweating Urogenital- testicul…

🆘 Overdosage 177 words ▾

OVERDOSAGE Signs and Symptoms Drowsiness, lethargy, bradycardia and hypotension have been observed following overdose with guanfacine. A 25-year-old female intentionally ingested 60 mg. She presented with severe drowsiness and bradycardia of 45 beats/minute.

Gastric lavage was performed and an infusion of isoproterenol (0.8 mg in 12 hours) was administered. She recovered quickly and without sequelae. A 28-year-old female who ingested 30 - 40 mg developed only lethargy, was treated with activated charcoal and a cathartic, was monitored for 24 hours, and was discharged in good health.

A 2-year-old male weighing 12 kg who ingested up to 4 mg of guanfacine developed lethargy. Gastric lavage (followed by activated charcoal and sorbitol slurry via NG tube) removed some tablet fragments within 2 hours after ingestion, and vital signs were normal. During 24-hour observation in ICU, systolic pressure was 58 and heart rate 70 at 16 hours post-ingestion.

No intervention was required, and child was discharged fully recovered the next day. Treatment of Overdosage Gastric lavage and supportive therapy as appropriate. Guanfacine is not dialyzable in clinically significant amounts (2.4%).

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Guanfacine tablets, are an orally active antihypertensive agent whose principal mechanism of action appears to be stimulation of central α 2 -adrenergic receptors. By stimulating these receptors, guanfacine reduces sympathetic nerve impulses from the vasomotor center to the heart and blood vessels. This results in a decrease in peripheral vascular resistance and a reduction in heart rate.

The dose-response relationship for blood pressure and adverse effects of guanfacine given once a day as monotherapy has been evaluated in patients with mild to moderate hypertension. In this study patients were randomized to placebo or to 0.5 mg, 1 mg, 2 mg, 3 mg, or 5 mg of guanfacine. Results are shown in the following table.

A useful effect was not observed overall until doses of 2 mg were reached, although responses in white patients were seen at 1 mg; 24 hour effectiveness of 1 mg to 3 mg doses was documented using 24 hour ambulatory monitoring. While the 5 mg dose added an increment of effectiveness, it caused an unacceptable increase in adverse reactions. Mean Changes (mm Hg) from Baseline in Seated Systolic and Diastolic Blood Pressure for Patients Completing 4 to 8 Weeks of Treatment with Guanfacine Monotherapy Mean Change S/D* Seate d n= (range) Placebo 0.5 mg 1 mg 2 mg 3 mg 5 mg White Patients Black Patients 11 to 30 8 to 28 -1/-5 -3/-5 -6/-8 0/-2 -8/-9 -3/-5 -12/-11 -7/-7 -15/-12 -8/-9 -18/-16 -19/-15 * S/D = Systolic/diastolic blood pressure Controlled clinical trials in patients with mild to moderate hypertension who were receiving a thiazide-type diuretic have defined the dose-response relationship for blood pressure response and adverse reactions of guanfacine given at bedtime and have shown that the blood pressure response to guanfacine can persist for 24 hours after a single dose.

In the 12-week placebo-controlled dose-response study, patients were randomized to placebo or to doses of 0.5, 1, 2, and 3 mg of guanfacine, in addition to 25 mg chlorthalidone, each given at bedtime. The observed mean changes from baseline, tabulated below, indicate the similarity of response for placebo and the 0.5 mg dose. Doses of 1, 2, and 3 mg resulted in decreased blood pressure in the sitting position with no real differences among the three doses.

In the standing position, there was some increase in response with dose. Mean Decreases (mm Hg) in Seated and Standing Blood Pressure for Patients Treated with Guanfacine in Combination with Chlorthalidone Mean Change n = Placebo 63 0.5 mg 63 1 mg 64 2 mg 58 3 mg 59 S/D* Seated S/D* Standing -5/-7 -3/-5 -5/-6 -5/-4 -14/-13 -11/-9 -12/-13 -9/-10 -16/-13 -15/-12 * S/D = Systolic/diastolic blood pressure While most of the effectiveness of guanfacine in combination (and as monotherapy in white patients) was present at 1 mg, adverse reactions at this dose were not clearly distinguishable from those associated with placebo.

Adverse reactions were clearly present at 2 and 3 mg (see ADVERSE REACTIONS ). In a second 12-week placebo-controlled study of 1, 2 or 3 mg of guanfacine hydrochloride administered with 25 mg of chlorthalidone once daily, a significant decrease in blood pressure was maintained for a full 24 hours after dosing. While there was no significant difference between the 12 and 24 hour blood pressure readings, the fall in blood pressure at 24 hours was numerically smaller, suggesting possible escape of blood pressure in some patients and the need for individualization of therapy.

In a double-blind, randomized trial, either guanfacine or clonidine was given at recommended doses with 25 mg chlorthalidone for 24 weeks and then abruptly discontinued. Results showed equal degrees of blood pressure reduction with the two drugs and there was no tendency for blood pressures to increase despite maintenance of the same daily dose of the two drugs. Signs and symptoms of rebound phenomena were infrequent upon discontinuation of either drug.

Abrupt withdrawal of clonidine produced…

📦 How Supplied / Storage and Handling 140 words ▾

HOW SUPPLIED Guanfacine tablets, USP are available in 2 tablet strengths of guanfacine (as the hydrochloride salt) as follows: 1 mg: white, oval, flat-faced, beveled edge tablet with “XI” on one side and “130” on the other side. They are available as follows: Bottles of 30 with child-resistant closure: NDC 70700-301-30 Bottles of 100 with child-resistant closure: NDC 70700-301-01 2 mg: white, oval, flat-faced, beveled edge tablet with “XI” on one side and “131” on the other side. They are available as follows: Bottles of 30 with child-resistant closure: NDC 70700-302-30 Bottles of 100 with child-resistant closure: NDC 70700-302-01 Bottles of 500: NDC 70700-302-05 Store at 20º to 25 ºC (68 ºF to 77 ºF) [see USP Controlled Room Temperature].

Dispense in a tight, light-resistant container. Manufactured for: Xiromed, LLC Florham Park, NJ 07932 Made in India Rev 02/2024 PI301-00

📋 Description 100 words ▾

DESCRIPTION Guanfacine tablets, USP are centrally acting antihypertensive with α 2 -adrenoceptor agonist properties in tablet form for oral administration. The chemical name of guanfacine hydrochloride, USP is N-amidino-2-(2,6-dichlorophenyl) acetamide hydrochloride and its molecular weight is 282.56. Its structural formula is: Guanfacine hydrochloride, USP is a white to off-white powder; sparingly soluble in water and alcohol and slightly soluble in acetone.

Each tablet, for oral administration, contains guanfacine hydrochloride, USP equivalent to 1 mg or 2 mg guanfacine. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, pregelatinized starch, and stearic acid. Meets USP Dissolution Test 2.

042bf3b6-figure-01

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
100 tablets70700-0301-01 7,834 Rx · $134,071
30 tablets this page70700-0301-30 No Medicaid data
Drug total (last 4 qtrs): 7,834 Rx · 388,513 units · $134,071 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by XIROMED, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 100 tablets (70700-0301-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
XIROMED, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 70700-0290-22 · Xiromed 70700-0302-01 · XIROMED, →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.