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Orforglipron

Orforglipron is a GLP-1 receptor agonist taken by mouth to help adults with obesity or overweight lose weight and keep it off long term.

Brand name Foundayo
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 19, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 8, 2026
Orforglipron at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Foundayo (orforglipron) is a newer once-daily GLP-1 tablet, a by-mouth alternative to the GLP-1 injections, that activates GLP-1 receptors to curb appetite and food intake, used with diet and exercise for long-term weight loss in adults with obesity or overweight plus a related health condition. Most people tolerate it reasonably well, though nausea is common, along with constipation or diarrhea, mostly early on and after dose increases. It carries a boxed warning about medullary thyroid carcinoma, a rare thyroid cancer, so skip it if you or a relative has had that cancer or MEN 2 (an inherited tumor syndrome), and report a neck lump or lasting hoarseness.

Clinical pearls

  • If you take the pill, use a backup barrier method for 30 days after starting and after every dose increase.
  • Clarithromycin, ritonavir, carbamazepine and simvastatin all interact with it, so make sure every prescriber knows you take Foundayo.
  • Swallow the tablet whole, never broken, crushed or chewed, at any time of day, with or without food.
  • If stomach pain becomes severe or spreads to your back, call your doctor right away, since it can signal pancreatitis.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Foundayo carries a boxed warning about a rare type of thyroid cancer called medullary thyroid carcinoma (MTC). Some drugs in the same class have caused thyroid tumors in rats and mice. Orforglipron did not cause those tumors in rodents, but it does act on the same receptor in humans — and whether this translates to a real risk of MTC in people is not yet known. Because of this uncertainty, Foundayo must not be used by anyone with a personal or family history of MTC, or by anyone with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) — a genetic condition that raises the risk of certain hormone-related tumors. Watch for possible warning signs: a lump or mass in the neck, difficulty swallowing, shortness of breath, or a hoarse voice that does not go away. Routine blood tests or ultrasounds to screen for this cancer are not reliably helpful, so knowing the symptoms matters.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asTablet
Earliest FDA record2024
Companies listing it with the FDA1
FDA label last updatedJul 29, 2026
FDA’s strongest warning (boxed)Yes, read the warning

Patient Information Guide A plain-language walkthrough of Orforglipron, written from its FDA label.

What Orforglipron Is Used For

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Orforglipron is approved at the ingredient level for weight management in adults. The only currently supported product is Foundayo tablets.

  • Foundayo is indicated — alongside a reduced-calorie diet and increased physical activity — to reduce excess body weight and maintain that weight loss long term in adults with obesity, or in adults who are overweight and have at least one weight-related health condition (such as high blood pressure, type 2 diabetes, or abnormal cholesterol).
  • Foundayo is not recommended for use at the same time as another GLP-1 receptor agonist medication.

How Orforglipron Works

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Orforglipron is a GLP-1 receptor agonist — meaning it binds to and activates the GLP-1 receptor, a natural receptor found throughout the body, including in areas of the brain that control hunger and how much you eat. By activating this receptor, Foundayo reduces appetite and caloric intake. It also slows down how quickly food leaves the stomach (called gastric emptying), which can contribute to feeling fuller longer. Together, these effects support meaningful weight loss over time.

Orforglipron Dosage

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Foundayo is taken as an oral tablet once daily, with or without food. Your prescriber will start you at a very low dose and increase it slowly over several months — this step-up approach is specifically designed to reduce nausea and other stomach side effects. The dose is advanced no faster than every 30 days, based on how well you tolerate it and how your body responds.

  • Swallow Foundayo tablets whole — never break, crush, or chew them.
  • Take no more than one tablet per day.
  • If you miss a dose, take it as soon as you remember — but never double up on the next day's dose.
  • If you miss 7 or more doses in a row, talk to your prescriber before restarting — you may need to go back to a lower dose to avoid digestive side effects.

Dosing details from the FDA-approved label

From the Orforglipron prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Recommended dosage and administration (starting dosage and escalation)
    • Starting dosage is 0.8 mg orally once daily
    • After at least 30 days on the 0.8 mg dosage, increase to 2.5 mg once daily
    • After at least 30 days on the 2.5 mg dosage, increase to 5.5 mg once daily
    • May be increased to the next dosage level (9 mg, 14.5 mg, or 17.2 mg once daily) after at least 30 days on the current dosage, based on treatment response and tole
    • Maximum: 17.2 mg once daily
    • With or without food
  • Concomitant use with a strong CYP3A4 inhibitor
    • Maximum dosage is 9 mg once daily when used concomitantly with a strong CYP3A4 inhibitor
    • Maximum: 9 mg once daily
    • Avoid strong CYP3A4 inhibitors that also inhibit OATP1B
  • Concomitant use with moderate CYP3A4 inducers
    • Monitor effectiveness and escalate dosage as needed
    • Avoid strong CYP3A4 inducers
  • Missed dose
    • Take the dose as soon as possible
    • Do not double up the next dose
    • If 7 or more consecutive doses are missed, reinitiate dosage escalation at a lower dosage
    • Reinitiating at a lower dosage reduces the risk of gastrointestinal adverse reactions
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Take FOUNDAYO orally once daily, with or without food. ( 2.1 ) Swallow tablets whole. Do not break, crush, or chew. ( 2.1 ) Do not take more than one tablet per day. ( 2.1 ) Starting dosage is 0.8 mg once daily. After at least 30 days, increase dosage to 2.5 mg once daily. ( 2.1 ) After at least 30 days on the 2.5 mg dosage, increase dosage to 5.5 mg once daily. ( 2.1 ) Dosage may be increased to the next dosage level (9 mg, 14.5 mg, or 17.2 mg once daily) after at least 30 days on the current dosage, based on treatment response and tolerability. ( 2.1 ) Maximum dosage is 17.2 mg once daily. ( 2.1 ) 2.1 Recommended Dosage and Administration Recommended Administration Take FOUNDAYO orally once daily, with or without food. Swallow tablets whole. Do not break, crush, or chew. Do not take more than one tablet per day. Recommended Dosage Escalation Follow the FOUNDAYO starting dosage and escalation described below to reduce the risk of gastrointestinal (GI) adverse reactions [see Warnings and Precautions ( 5.3 ), Adverse Reactions ( 6 )] . The starting dosage is 0.8 mg orally once daily. After at least 30 days on the 0.8 mg dosage, increase the dosage to 2.5 mg once daily. After at least 30 days on the 2.5 mg dosage, increase the dosage to 5.5 mg once daily. The dosage may be increased to the next dosage level (9 mg, 14.5 mg, or 17.2 mg once daily) after at least 30 days on the current dosage, based on treatment response and tolerability. The maximum dosage of FOUNDAYO is 17.2 mg once daily. 2.2 Dosage Modification for Concomitant Use with CYP3A4 Inhibitors and CYP3A4 Inducers FOUNDAYO dosage modification may be required to manage interactions with some concomitant medications [see Drug Interactions ( 7.1 ), Clinical Pharmacology ( 12.3 )] . Strong CYP3A4 Inhibitors Avoid strong CYP3A4 inhibitors that also inhibit OATP1B when taking FOUNDAYO. The maximum dosage of FOUNDAYO is 9 mg once daily when used concomitantly with a strong CYP3A4 inhibitor [see Drug Interactions ( 7.1 ), Clinical Pharmacology ( 12.3 )] . Strong and Moderate CYP3A4 Inducers Avoid strong CYP3A4 inducers when taking FOUNDAYO. Monitor FOUNDAYO effectiveness when concomitantly using moderate CYP3A4 inducers and escalate FOUNDAYO dosage as needed [see Dosage and Administration ( 2.1 , 2.3 ), Drug Interactions ( 7.1 ), Clinical Pharmacology ( 12.3 )] .

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Orforglipron Side Effects

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The most common side effects of Foundayo are digestive in nature and tend to be worst when starting or increasing the dose:

Common side effects

  • Nausea (most common, especially early on)
  • Constipation
  • Diarrhea
  • Vomiting
  • Indigestion (dyspepsia)
  • Stomach pain or bloating
  • Headache
  • Hair loss
  • Belching (eructation) or gas
  • Acid reflux (gastroesophageal reflux disease)
  • Fatigue

When to get medical help

  • Call your doctor right away if you have severe or ongoing stomach pain (especially spreading to your back) — this could be pancreatitis (inflamed pancreas)
  • Seek care if you notice a lump or mass in your neck, trouble swallowing, shortness of breath, or hoarseness that won't go away — these can be signs of a thyroid tumor
  • Get help if you have signs of low blood sugar (shakiness, sweating, confusion, dizziness), especially if you also take insulin or a sulfonylurea
  • Stop the medication and seek emergency help for signs of a severe allergic reaction: swelling of the face or throat, trouble breathing, or severe rash
  • See a doctor if you have signs of dehydration or worsening kidney function (decreased urination, swelling) after episodes of nausea, vomiting, or diarrhea
  • Tell your doctor promptly about new or worsening vision problems if you have type 2 diabetes — eye complications (diabetic retinopathy) should be monitored
  • Report sudden severe abdominal pain with fever or nausea — this may signal a gallbladder problem

Orforglipron Warnings and Precautions

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  • Possible thyroid cancer risk (MTC): Foundayo must not be taken by anyone with a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Watch for a lump in the neck, difficulty swallowing, shortness of breath, or lasting hoarseness, and report these to your doctor right away.
  • Acute pancreatitis: Foundayo has been associated with inflamed pancreas, which can be serious or life-threatening. Stop taking it and seek care if you have severe, persistent stomach pain — especially if it radiates to your back.
  • Severe digestive reactions: Nausea, vomiting, and diarrhea can become severe. Foundayo is not recommended for people with severe gastroparesis (very slow stomach emptying).
  • Kidney injury from dehydration: Severe vomiting or diarrhea can lead to dehydration, which can stress the kidneys. Your doctor may monitor kidney function, especially when starting or increasing your dose.
  • Low blood sugar (hypoglycemia): If you also take insulin or a drug that stimulates insulin (like a sulfonylurea), your risk of low blood sugar goes up. Know the signs: shakiness, sweating, confusion, dizziness.
  • Gallbladder disease: Cases of gallbladder problems (cholecystitis) have been reported. Tell your doctor about new or severe upper abdominal pain.
  • Eye complications (diabetic retinopathy): If you have type 2 diabetes with existing eye disease, your doctor should monitor for progression.
  • Risk of breathing in stomach contents during anesthesia: Tell all surgical and anesthesia providers that you take Foundayo before any planned procedure.

Orforglipron Interactions

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Foundayo has several important drug interactions to be aware of:

  • Strong CYP3A4 inhibitors (e.g., clarithromycin) — raise Foundayo levels significantly, so your maximum dose will be capped lower than usual.
  • Strong CYP3A4 inhibitors that also block OATP1B (e.g., ritonavir) — should be avoided entirely with Foundayo.
  • Strong CYP3A4 inducers (e.g., carbamazepine) — greatly reduce Foundayo's effectiveness; avoid this combination.
  • Moderate CYP3A4 inducers (e.g., efavirenz) — can reduce Foundayo levels; your doctor may need to increase your dose and monitor effectiveness.
  • Simvastatin — Foundayo raises levels of simvastatin's active form two-fold; the daily simvastatin dose should be kept low while on Foundayo.
  • Insulin or sulfonylureas (insulin-stimulating diabetes pills) — combining with Foundayo increases low blood sugar risk; your doses of these medications may need to be reduced.
  • Oral hormonal contraceptives — because Foundayo slows stomach emptying, it may reduce pill absorption; use a non-oral or barrier method for 30 days after starting Foundayo and after each dose increase.
  • Other GLP-1 receptor agonists — do not use at the same time as Foundayo.

Interactions listed in the FDA-approved label

From the Orforglipron prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Strong CYP3A4 inhibitors: CYP3A4 inhibitors increase FOUNDAYO exposure, which may increase the risk of FOUNDAYO-associated adverse reactions. Maximum dosage is 9 mg once daily with a strong CYP3A4 inhibitor.
  • Strong CYP3A4 inhibitors that also inhibit OATP1B (e.g., ritonavir): Expected to significantly increase plasma concentrations of FOUNDAYO, which may increase the risk of FOUNDAYO-associated adverse reactions. Avoid concomitant use.
  • Strong CYP3A4 inducers: Induction of CYP3A4 decreases FOUNDAYO exposure, which may reduce the effectiveness of FOUNDAYO. Avoid concomitant use.
  • Moderate CYP3A4 inducers: Induction of CYP3A4 decreases FOUNDAYO exposure, which may reduce the effectiveness of FOUNDAYO. Monitor FOUNDAYO effectiveness and escalate dosage as needed.
  • Simvastatin: Use with FOUNDAYO increased exposure of the active metabolite simvastatin acid two-fold; a two-fold increase at the highest simvastatin dose could be clinically meaningful. Do not exceed simvastatin 20 mg once daily.
  • Insulin or insulin secretagogue (e.g., sulfonylurea): FOUNDAYO stimulates insulin release in the presence of elevated blood glucose concentrations, which could increase the risk for hypoglycemia. When initiating FOUNDAYO, consider reducing the dose of concomitantly administered insulin or insulin secretagogues.
  • Oral medications (general): FOUNDAYO delays gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications.
  • Oral hormonal contraceptives: FOUNDAYO delays gastric emptying and may impact absorption of oral medications; hormonal contraceptives not administered orally should not be affected. Switch to a non-oral contraceptive method or add a barrier method for 30 days after initiation and for 30 days after each dose escalation.
Read the label’s full interactions text

7 DRUG INTERACTIONS Strong CYP3A4 Inhibitors: The maximum dosage of FOUNDAYO is 9 mg once daily when used concomitantly with a strong CYP3A4 inhibitor. Avoid concomitant use with strong CYP3A4 inhibitors that also inhibit OATP1B. ( 7.1 ) CYP3A4 Inducers: Avoid concomitant use with strong CYP3A4 inducers. Monitor FOUNDAYO effectiveness and escalate dosage as needed when used concomitantly with moderate CYP3A4 inducers. ( 7.1 ) Simvastatin: Do not exceed simvastatin 20 mg once daily when used concomitantly with FOUNDAYO. ( 7.2 ) FOUNDAYO delays gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications. ( 7.3 ) 7.1 Effect of Other Drugs on FOUNDAYO Table 2 includes clinically relevant interactions where concomitant use of other drugs affects FOUNDAYO. Table 2: Clinically Relevant Effects of Other Drugs on FOUNDAYO Strong CYP3A4 Inhibitors Intervention The maximum dosage of FOUNDAYO is 9 mg once daily when used concomitantly with a strong CYP3A4 inhibitor. Avoid concomitant use of FOUNDAYO with strong CYP3A4 inhibitors that also inhibit OATP1B (e.g., ritonavir) [see Dosage and Administration ( 2.2 )] . Clinical Impact CYP3A4 inhibitors increase FOUNDAYO exposure [see Clinical Pharmacology ( 12.3 )] , which may increase the risk of FOUNDAYO-associated adverse reactions. Strong CYP3A4 inhibitors that also clinically inhibit OATP1B are expected to significantly increase plasma concentrations of FOUNDAYO, which may increase the risk of FOUNDAYO-associated adverse reactions [see Warnings and Precautions ( 5.3 ), Adverse Reactions ( 6.1 )] . Strong CYP3A4 Inducers Intervention Avoid concomitant use of FOUNDAYO with strong CYP3A4 inducers. Clinical Impact Induction of CYP3A4 decreases FOUNDAYO exposure [see Clinical Pharmacology ( 12.3 )] , which may reduce the effectiveness of FOUNDAYO.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before Taking Orforglipron

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  • Personal or family history of medullary thyroid carcinoma (MTC) or MEN 2 — Foundayo is contraindicated; do not take it.
  • Known serious allergy to orforglipron or any ingredient in Foundayo — do not take it.
  • Pancreatitis history or gallbladder disease — tell your doctor before starting.
  • Severe gastroparesis (very slow stomach emptying) — Foundayo is not recommended.
  • Severe liver disease (Child-Pugh Class C) — Foundayo is not recommended; mild or moderate liver disease is generally okay, no dose change needed.
  • Kidney disease — no dose adjustment needed, but kidney function should be monitored if you have significant dehydration from side effects.
  • Pregnancy — Foundayo may harm the fetus; stop it as soon as pregnancy is confirmed and talk to your doctor.
  • Breastfeeding — Foundayo is not recommended for nursing mothers.
  • Children and adolescents — safety and effectiveness have not been established in patients under 18.
  • Older adults (65+) — no overall difference in safety or effectiveness compared to younger adults; no special dose adjustment required.

Orforglipron Overdose

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If you or someone else takes too much Foundayo, contact Poison Control (1-800-222-1222) or seek emergency care right away. Treatment focuses on managing symptoms as they appear. Because orforglipron stays in the body for an extended period (its half-life is roughly 29 to 49 hours), symptoms from an overdose may need to be watched and treated for some time.

What Orforglipron Does in the Body

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Foundayo reduces body weight, with more of the loss coming from fat mass than from lean (muscle) mass. It decreases how much you eat, most likely by lowering appetite through its action on brain receptors. Foundayo also slows how quickly food moves from the stomach into the intestine (gastric emptying) — this effect is greatest after the first dose and diminishes over time. At the highest recommended dose, Foundayo does not meaningfully affect heart rhythm (QTc interval).

How Your Body Processes Orforglipron

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After you take Foundayo by mouth, peak levels in the blood are reached about 4 to 8 hours later, and stable levels in the body are achieved after roughly one week of daily dosing. Food does not meaningfully affect how much of the drug is absorbed, so you can take it with or without a meal. Orforglipron is broken down mainly by the liver (via an enzyme called CYP3A4), and most of the drug leaves the body through the stool, with very little exiting in urine. Its elimination half-life — the time it takes the body to clear half the drug — is approximately 29 to 49 hours, meaning it stays active in your system for a day or two after each dose.

How to Store Orforglipron

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Store FOUNDAYO at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

Orforglipron: Pharmacist Answers to Common Questions

Quick, plain-English answers to the questions patients ask most about Orforglipron — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is Foundayo, and how is it different from the GLP-1 shots I've heard about?

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Foundayo (orforglipron) works the same way as injectable GLP-1 medications — it activates the GLP-1 receptor to reduce your appetite and help you eat less — but it comes as a pill you swallow once a day rather than an injection. That's actually what makes it different: it's the first approved oral GLP-1 receptor agonist tablet for weight management in this class. You still need to pair it with a lower-calorie diet and more physical activity for it to work best.

What side effects should I expect, and will they go away?

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Nausea, constipation, diarrhea, and vomiting are the most common ones, and they tend to hit hardest when you first start or when your dose gets increased. For most people, these digestive side effects ease up over time as your body adjusts. The slow dose escalation — your doctor gradually increases your dose over several months — is specifically designed to make this easier. If they're really bothering you, let your doctor know; there's no need to just tough it out.

I've heard about a thyroid cancer warning with these types of drugs — should I be worried?

▾
This is a fair question, and the answer is nuanced. Some similar medications have caused thyroid tumors in rodents, but Foundayo did not produce those tumors in animal studies. Whether there's a real risk in humans is still not fully known. What we do know is that if you or a close family member has had a rare thyroid cancer called medullary thyroid carcinoma (MTC), or a genetic condition called MEN 2, you should not take Foundayo at all. For everyone else, just be aware of warning signs: a lump in your neck, a voice change that won't go away, trouble swallowing, or shortness of breath. Tell your doctor right away if any of those appear.

Can I take Foundayo if I also take other medications?

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Some medications do interact with Foundayo, so it's really important to give your pharmacist or doctor a full list of everything you take. A few highlights: certain antibiotics and antifungals can raise Foundayo levels, while some seizure and HIV medications can lower them — all of which may require a dose change. If you take the cholesterol drug simvastatin, your dose of that will need to be kept lower while you're on Foundayo. And if you take insulin or a sulfonylurea (a diabetes pill that stimulates insulin), watch closely for signs of low blood sugar, because combining them raises that risk. Oral birth control pills may also be less effective due to the way Foundayo slows stomach emptying — talk to your doctor about using a backup method.

Can I take Foundayo if I'm pregnant or trying to get pregnant?

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No — Foundayo is not recommended during pregnancy. Weight loss doesn't benefit a pregnant person, and there's potential for harm to the baby. If you find out you're pregnant while taking it, stop the medication and call your doctor right away. Because the drug can also affect how oral birth control pills are absorbed, your doctor will advise you to use a non-oral or backup method of contraception when you start Foundayo and whenever your dose is increased.

What should I do if I miss a dose?

▾
Take the missed dose as soon as you remember — but don't double up the next day. If you've missed 7 or more days in a row, don't just restart at your current dose. Contact your prescriber first, because you may need to go back to a lower dose temporarily. That's not a setback — it's simply the safest way to avoid a nasty wave of nausea and stomach upset that can happen when you restart at a higher level.

Is Orforglipron available over the counter?

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No. Orforglipron is a prescription medicine: every Orforglipron product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Orforglipron first available?

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The earliest FDA record we hold for Orforglipron is from 2024: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Orforglipron was first used.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More About Orforglipron on HelloPharmacist

Detailed Data & References for Orforglipron Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Orforglipron Forms and Strengths (How It Comes)

Orforglipron is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Orforglipron inactive ingredients by manufacturer.

Tablet

By mouth
Brands Foundayo
How this form is used
What it may be used for
  • Foundayo tablets are indicated to reduce excess body weight and maintain weight loss long term in adults with obesity or overweight with at least one weight-related health condition, used together with a reduced-calorie diet and increased physical activity
Important instructions
  • Foundayo tablets are taken by mouth once daily, with or without food
  • Foundayo tablets must be swallowed whole — do not break, crush, or chew them
  • Do not take more than one Foundayo tablet per day
  • If you miss 7 or more Foundayo doses in a row, contact your prescriber — restarting may require going back to a lower dose to avoid stomach side effects
Available strengths 6 strengths
12 FDA-listed product records ⓘ

Orforglipron on the U.S. Market: Products, Makers and Brands

How Orforglipron appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1 company lists 6 Orforglipron product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2024. Brand names on the directory include Foundayo; the rest are generics.

1
Dose forms ⓘ
1
Labelers (makers, repackagers, distributors)
1
Brand names
6
FDA-listed product records ⓘ
2024
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (24) · Unfinished tablet, film coated (14) · Unfinished capsule (6) — bulk drug substance and unfinished product sold to compounders and other manufacturers to finish, and multi-item kits. These aren’t counted in the dose-form total above.

Compare Orforglipron Products

A representative set of FDA-listed product records for Orforglipron — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Tablet
0.8 mg Oral Eli Lilly and Company NDA View NDC →
2.5 mg Oral Eli Lilly and Company NDA View NDC →
5.5 mg Oral Eli Lilly and Company NDA View NDC →
9 mg Oral Eli Lilly and Company NDA View NDC →
14.5 mg Oral Eli Lilly and Company NDA View NDC →
17.2 mg Oral Eli Lilly and Company NDA View NDC →

Showing 6 of 6 products — FDA National Drug Code Directory. See every product, package size and price: browse all 6 Orforglipron NDCs →

Orforglipron Recall History

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Orforglipron recalls since July 2021.

✅No Orforglipron recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Oct 8, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Orforglipron RxCUI 2739838 1 dose form · 6 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 2739843 In current FDA listings
    Clinical drug / strength (SCD) 0.8 MG RxCUI 2739844 2.5 MG RxCUI 2739852 5.5 MG RxCUI 2739856 9 MG RxCUI 2739860 14.5 MG RxCUI 2739864 17.2 MG RxCUI 2739868

Look up RxCUI 2739838 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Orforglipron Costs Pharmacies (NADAC Benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet, Film Coated · Oral 2.5 mg $20.84 per tablet NDC details & price history
Tablet, Film Coated · Oral 0.8 mg $20.89 per tablet NDC details & price history
Tablet, Film Coated · Oral 9 mg $20.85 per tablet NDC details & price history
Tablet, Film Coated · Oral 5.5 mg $20.82 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Orforglipron Brand Names

Orforglipron is sold under one brand name in the FDA directory — Foundayo. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Foundayo

Who Makes Orforglipron: Manufacturers and Labelers

One company lists Orforglipron products with the FDA. By number of product records, the largest are Eli Lilly and Company. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Eli Lilly and Company 6

Sources for This Orforglipron Page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jul 29, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Orforglipron.
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Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
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Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Orforglipron after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
Finished products in the current FDA directory
6
Companies listing them (makers, repackagers, distributors)
1
FDA labeler codes behind them ⓘ
1
Linked representative label ⓘ
Eli Lilly and Company
Linked label effective
Jul 29, 2026
Composite sections available
24
Linked SPL Set ID
8ac446c5-feba-474f-a103-23facb9b5c62
Linked SPL Document ID
ebe44919-a00d-4ea1-a511-18e6a87da34c
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Eli Lilly and Company is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →