FDA-filed SPL labeling · retrieved through openFDA

Lithium Carbonate

Lithium carbonate is a mood-stabilizing medication used to treat and prevent manic episodes in bipolar disorder.

Brand names LithobidLithium carbonicumRheumatsm
Drug class Mood Stabilizer
Rx/OTC Forms 4 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 54 clinical label sets 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 →

At a glance
Linked label effectiveNov 22, 2022
Clinical labels in scope 54
AvailabilityRx/OTC
Earliest approval/marketing year 1970
FDA-listed product records 203
Boxed warningYes
How we combine label and product data →
No current FDA shortage listed · checked Sep 20, 2026
Lithium Carbonate at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Lithium carbonate is an established mood stabilizer for treating and preventing manic episodes in bipolar disorder. Because the effective dose and the toxic dose are very close together, regular blood level monitoring is not just recommended — it is essential for safe use. Stay consistent with your salt intake, stay hydrated, and always tell every member of your healthcare team that you take lithium.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert

Lithium toxicity is a serious risk — and it can happen even at doses that are supposed to be therapeutic. The level of lithium that causes harm is dangerously close to the level that helps. Before you start lithium, your prescriber needs access to reliable, timely lithium blood-level testing. Watch for warning signs like tremor, confusion, muscle twitching, or slurred speech — and get medical help immediately if they occur. Do not miss your scheduled blood tests.

Read the full warning on DailyMed →

📖 Lithium Carbonate: Patient Information Guide

A plain-language walkthrough of Lithium Carbonate — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Lithium carbonate is a mood-stabilizing medication approved for the following uses across its supported formulations:

  • Treatment of acute manic episodes in bipolar disorder (adults and, for certain formulations, patients 7 years and older)
  • Maintenance treatment of bipolar disorder — to reduce how often manic episodes happen and how severe they are when they do
  • One formulation is specifically approved as monotherapy (used alone) for bipolar I disorder, including both acute manic or mixed episodes and maintenance treatment, in patients 7 years and older
  • Lithobid extended-release tablets are indicated for acute mania and long-term control in adults
⚙️How it works

The exact way lithium stabilizes mood is not fully understood. What is known is that it acts as a mood-stabilizing agent in the brain — but scientists have not yet identified the precise mechanism. After you swallow it, lithium is completely absorbed and distributes throughout the body's water. It is not broken down or metabolized at all; your kidneys filter it out unchanged. Because the kidneys handle lithium in a way similar to sodium (salt), changes in your hydration or salt levels directly affect how much lithium stays in your body — which is why diet and fluid balance matter so much with this drug.

💊How it's taken

Lithium carbonate is taken by mouth in capsule or tablet form, usually two to three times daily depending on the specific product and your prescriber's instructions. Extended-release formulations are typically dosed less frequently than immediate-release forms.

  • Always take it exactly as prescribed — dose is carefully adjusted based on regular blood level tests
  • Lithobid extended-release tablets are taken twice daily during both acute treatment and long-term maintenance, as directed
  • If you miss a dose, follow your prescriber's or pharmacist's guidance — never double up without instruction
  • Blood lithium levels are checked frequently at first (twice a week during the acute phase) and at least every two months during stable long-term treatment
🤒Side effects — in detail

Some side effects are common when starting lithium, while others are signs of a more serious problem:

  • Fine hand tremor
  • Increased thirst and urination
  • Nausea, stomach discomfort, or diarrhea — especially early in treatment
  • Dizziness and fatigue
  • Weight changes or ankle swelling
  • Metallic or salty taste in the mouth
  • In children (ages 7–17): nausea/vomiting, tremor, dizziness, rash, unsteady gait, decreased appetite, and blurry vision were among the most commonly reported effects

Seek immediate medical help if you develop confusion, slurred speech, severe tremor, muscle twitching, seizures, or loss of consciousness — these are signs of lithium toxicity and require urgent care.

⚠️Warnings & precautions
  • Lithium toxicity: The toxic level is very close to the therapeutic level. Early signs include tremor, lightheadedness, and weakness. Severe toxicity can cause seizures, coma, and death. Blood tests to monitor your lithium level are essential throughout treatment.
  • Dehydration and low sodium: Illness with fever, sweating, vomiting, or diarrhea can raise lithium to dangerous levels. Maintain normal salt intake and stay well hydrated.
  • Kidney damage: Long-term lithium use can cause chronic kidney disease. Kidney function is monitored regularly during treatment.
  • Thyroid problems: Lithium can cause an underactive or, less commonly, overactive thyroid. Thyroid function is checked before and during treatment.
  • Serotonin syndrome: Combining lithium with certain antidepressants or other serotonergic drugs can trigger a potentially life-threatening reaction with agitation, rapid heart rate, and muscle stiffness.
  • Brugada syndrome: Lithium has been linked to unmasking a heart rhythm disorder that can cause sudden death. Tell your doctor if you have unexplained fainting or a family history of sudden unexplained death.
  • Brain syndrome: Combining lithium with antipsychotic medications has been linked to a serious neurological syndrome, including a risk of irreversible brain damage.
  • Elevated calcium: Long-term use can raise blood calcium levels and affect the parathyroid glands.
🔀What it interacts with

Many common medications and health conditions can affect how much lithium stays in your body — raising it to toxic levels or lowering it so it stops working:

  • Diuretics (water pills): Can reduce lithium clearance and raise blood levels dangerously
  • NSAIDs (ibuprofen, naproxen): Reduce lithium excretion, increasing toxicity risk
  • ACE inhibitors and ARBs (lisinopril, valsartan): Raise steady-state lithium levels
  • Serotonergic drugs (SSRIs, SNRIs, MAOIs, tramadol, triptans, St. John's Wort): Increase risk of serotonin syndrome
  • Antipsychotic medications: Combined use raises risk of serious neurological reactions
  • Metronidazole (antibiotic): Can increase lithium levels by reducing kidney clearance
  • Calcium channel blockers (verapamil, diltiazem): May worsen nervous system side effects
  • Iodide preparations: Can worsen lithium-induced hypothyroidism
  • Theophylline, acetazolamide, sodium bicarbonate: Can lower lithium levels by increasing how fast the kidneys clear it

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Kidney disease: Lithium is cleared entirely by the kidneys; severe kidney impairment makes it very dangerous to use. Even mild-to-moderate kidney impairment requires lower starting doses and close monitoring.
  • Pregnancy: Lithium may cause harm to the baby, including possible heart defects. If you are pregnant or planning to become pregnant, discuss the risks and benefits carefully with your prescriber.
  • Breastfeeding: Lithium passes into breast milk at significant levels and is not recommended during breastfeeding. If you choose to breastfeed, your infant must be monitored closely for toxicity signs.
  • Children: Safety and effectiveness have been established only in patients 7 years and older for certain formulations; lithium has not been established as safe in children under 7 with bipolar I disorder.
  • Older adults: Kidney function naturally declines with age, raising the risk of toxicity. Dose selection should be conservative and kidney function monitored.
  • Heart conditions: Lithium should be avoided in patients with Brugada syndrome. Tell your doctor about any heart rhythm problems or history of unexplained fainting.
  • Thyroid or calcium problems: Tell your doctor about any existing thyroid or parathyroid conditions before starting lithium.
  • Allergy to inactive ingredients: Lithium carbonate is contraindicated if you have a known allergy to any inactive ingredient in the capsule or tablet formulation.
🚑If you take too much

Lithium levels above the therapeutic range can cause serious harm, and at very high levels can lead to seizures, coma, and irreversible brain damage. There is no specific antidote for lithium poisoning. If you suspect an overdose or toxic reaction, call the National Poison Control Center at 1-800-222-1222 immediately or go to the nearest emergency room. Hemodialysis (a machine that filters the blood) is the preferred treatment for severe lithium toxicity.

🔬Pharmacokinetics — how your body processes it

After you take lithium carbonate by mouth, it is completely absorbed in the upper digestive tract. Immediate-release capsules and tablets reach peak blood levels within about 15 minutes to 3 hours; extended-release preparations take 2 to 6 hours to reach peak levels. Lithium spreads throughout the body's water and binds very little to proteins in the blood. It is not metabolized at all — the liver does not process it. Instead, the kidneys filter it out and excrete it in urine, with a half-life of approximately 18 to 36 hours (meaning it takes that long for half of it to leave your body). In children, how quickly the body clears lithium increases with body weight, so smaller children require lower doses to reach comparable blood levels.

📦How to store it

Store and Dispense Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Dispense in a tight, child-resistant container as defined in the USP/NF. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

📄 Written from Lithium Carbonate’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

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

What exactly does lithium do — is it like a sedative?
No, lithium isn't a sedative. It's a mood stabilizer, which means it helps keep your mood more even over time. It specifically targets mania — the high, energized, and sometimes dangerous state that happens with bipolar disorder. It can also reduce how often and how severely those episodes come back. Interestingly, scientists still aren't 100% sure of the exact way it works in the brain, but decades of use have shown it's one of the most effective tools for bipolar disorder.
Why do I need blood tests so often? Can't my doctor just judge by how I feel?
This is one of the most important things to understand about lithium: the amount that helps you and the amount that can seriously harm you are very close together. You can feel fine and still have a lithium level that's creeping into the danger zone. Regular blood tests — especially early in treatment — are the only reliable way to keep you safe. Think of them as a required part of how this medication works, not just an extra step.
What should I do if I get sick with a fever, vomiting, or diarrhea while on lithium?
Call your doctor as soon as you can. When you're sick, your body loses fluids and salt, and that causes your kidneys to hold onto more lithium than usual — which can push your level into the toxic range. The same goes for really heavy sweating in hot weather or during exercise. Your doctor may want to temporarily lower your dose or check your blood level. Don't wait it out on your own — this is a situation where acting early matters.
Are the side effects I'm feeling at the start going to go away?
Many of the early side effects — like mild nausea, increased thirst, more frequent urination, and a slight hand tremor — are common when starting lithium and often improve once your body adjusts and your dose is dialed in. That said, some of these, like the tremor and thirst, can persist. The key is to tell your doctor about anything that's bothering you, because some symptoms that seem minor can actually be early signs of your level being too high.
I've heard lithium can affect the kidneys and thyroid. Should I be worried?
It's a real concern that your doctor takes seriously — and that's exactly why they monitor your kidney function and thyroid regularly throughout your treatment. Long-term lithium use can affect how well the kidneys concentrate urine, and in some people it can cause the thyroid to become underactive (or rarely, overactive). Catching these changes early, through routine lab tests, means they can usually be managed well. Don't skip your monitoring appointments.
Is it safe to take ibuprofen or other over-the-counter pain relievers while on lithium?
This is a really important question. Common over-the-counter NSAIDs like ibuprofen and naproxen can raise your lithium level to dangerous amounts by reducing how quickly your kidneys clear it. It's best to avoid them unless your doctor specifically says it's okay. Acetaminophen (Tylenol) is generally a safer choice for pain or fever while you're on lithium, but always check with your pharmacist or prescriber before taking anything new — even things you'd normally buy without a prescription.
Is Lithium Carbonate available over the counter?
Both — Lithium Carbonate is sold both over the counter and by prescription, according to its FDA labeling. Lower strengths or certain forms are often available without a prescription, while higher strengths or specialized forms still require one. Ask your pharmacist which version is right for you.
When was Lithium Carbonate first available?
Lithium Carbonate has been available in the United States since at least 1970, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Lithium Carbonate?
Lithium Carbonate is supplied by 40 manufacturers listed in the FDA NDC Directory, including Remedyrepack Inc., Hikma Pharmaceuticals USA Inc., PD-Rx Pharmaceuticals, Inc..

💬 Answers drafted from Lithium Carbonate’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Lithium Carbonate comes

Lithium Carbonate is available in 4 forms. 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.

Capsule

By mouth
How this form is used
What it may be used for
  • Lithium Carbonate capsules are used to treat acute manic episodes of bipolar disorder
  • Lithium Carbonate capsules are used for maintenance treatment of bipolar disorder to reduce frequency and severity of manic episodes
  • Lithium Carbonate capsules are approved for these uses in patients 7 years and older as monotherapy for bipolar I disorder
Important instructions
  • Lithium Carbonate capsules are taken by mouth, typically multiple times daily as directed by your prescriber
  • Blood lithium levels must be monitored regularly throughout treatment
  • Follow your prescriber's instructions carefully — dose is adjusted based on your blood levels and clinical response
Available strengths 3 strengths
102 FDA-listed product records

Extended-release tablet

By mouth
Brands Lithobid
How this form is used
What it may be used for
  • Lithium Carbonate extended-release tablets are used to treat manic episodes of bipolar disorder
  • Lithium Carbonate extended-release tablets are used for maintenance treatment of bipolar disorder
  • Lithobid extended-release tablets are used to treat acute mania and for long-term control of bipolar disorder
Important instructions
  • Lithobid extended-release tablets are taken by mouth, generally twice daily during acute mania and long-term maintenance, as directed by your prescriber
  • Lithobid tablets should be taken consistently and blood lithium levels must be checked regularly — twice weekly during acute treatment
  • Geriatric patients using Lithobid may require lower doses and should be monitored closely for signs of toxicity
  • Lithium Carbonate extended-release tablets are taken as directed by your prescriber; do not crush or chew extended-release tablets unless instructed
Available strengths 2 strengths
63 FDA-listed product records

Tablet

By mouth
How this form is used
What it may be used for
  • Lithium Carbonate tablets are used to treat manic episodes of bipolar disorder
  • Lithium Carbonate tablets are used for maintenance treatment to prevent or reduce the intensity of future manic episodes
Important instructions
  • Lithium Carbonate tablets are taken by mouth as directed by your prescriber
  • Regular monitoring of blood lithium levels is required throughout treatment
  • Dose is individualized based on blood levels and how you respond clinically
Available strengths 2 strengths
24 FDA-listed product records

📊 Lithium Carbonate across the U.S. market

How Lithium Carbonate 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.

4
Dose forms
40
Manufacturers
6
Brand names
203
FDA-listed product records
1970
First marketed

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (8) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Remedyrepack Inc.22%
Hikma Pharmaceuticals USA Inc.11%
PD-Rx Pharmaceuticals, Inc.8%
Glenmark Pharmaceuticals Inc., USA7%
Bryant Ranch Prepack7%
A-S Medication Solutions5%
Other makers39%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Lithium Carbonate is used

A general measure of how commonly Lithium Carbonate is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Lithium Carbonate is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

1,097,615
Medicaid prescriptions filled (Q1–Q4 2025)
$18.3M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Lithium Carbonate prescribed? Of the 1,596 medications we measure, Lithium Carbonate ranks #164 by Medicaid prescriptions — more than 90% of them.

Where Lithium Carbonate ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Lithium Carbonate product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 300 mg oral capsule is the most-dispensed Lithium Carbonate product — about 28% of these Medicaid prescriptions.

lithium carbonate 300 MG Oral Capsule Most dispensed

304,435 Medicaid prescriptions (Q1–Q4 2025) 28% of Lithium Carbonate prescriptions shown $4.2M gross reimbursement (before rebates) ≈ $14 per prescription (gross)

Summed across the 8 of 51 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197889

lithium carbonate 300 MG Extended Release Oral Tablet

239,384 Medicaid prescriptions (Q1–Q4 2025) 22% of Lithium Carbonate prescriptions shown $4.8M gross reimbursement (before rebates) ≈ $20 per prescription (gross)

Summed across the 8 of 41 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197891

lithium carbonate 450 MG Extended Release Oral Tablet

212,343 Medicaid prescriptions (Q1–Q4 2025) 19% of Lithium Carbonate prescriptions shown $4M gross reimbursement (before rebates) ≈ $19 per prescription (gross)

Summed across the 4 of 19 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197892

lithium carbonate 150 MG Oral Capsule

120,539 Medicaid prescriptions (Q1–Q4 2025) 11% of Lithium Carbonate prescriptions shown $1.4M gross reimbursement (before rebates) ≈ $11 per prescription (gross)

Summed across the 5 of 32 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 311355

lithium carbonate 300 MG Oral Tablet

112,924 Medicaid prescriptions (Q1–Q4 2025) 10% of Lithium Carbonate prescriptions shown $2.1M gross reimbursement (before rebates) ≈ $18 per prescription (gross)

Summed across the 5 of 11 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197890

lithium carbonate 600 MG Oral Capsule

107,990 Medicaid prescriptions (Q1–Q4 2025) 10% of Lithium Carbonate prescriptions shown $2M gross reimbursement (before rebates) ≈ $18 per prescription (gross)

Summed across the 4 of 25 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197893

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Lithium Carbonate, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 34 of 179 listed Lithium Carbonate NDCs with Medicaid activity.

🔍 Compare Lithium Carbonate products

A representative set of FDA-listed product records for Lithium Carbonate — 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.)

Showing 200 of 203 products — FDA National Drug Code Directory. See every product, package size and price: browse all 203 Lithium Carbonate NDCs →

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) Lithium Carbonate RxCUI 42351 3 dose forms · 9 strengths
  1. Dose form (SCDF) Extended Release Oral Tablet RxCUI 372618 In current FDA listings
    Clinical drug / strength (SCD) 200 MG RxCUI 248306 300 MG RxCUI 197891 400 MG RxCUI 199762 450 MG RxCUI 197892
  2. Dose form (SCDF) Oral Capsule RxCUI 372616 In current FDA listings
    Clinical drug / strength (SCD) 150 MG RxCUI 311355 300 MG RxCUI 197889 600 MG RxCUI 197893
  3. Dose form (SCDF) Oral Tablet RxCUI 372617 In current FDA listings
    Clinical drug / strength (SCD) 250 MG RxCUI 199324 300 MG RxCUI 197890

Look up RxCUI 42351 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.

🏷️ Sold under these brand names

Lithobid Lithium carbonicum Rheumatsm

🏭 Manufacturers & labelers

Remedyrepack Inc. 44 Hikma Pharmaceuticals USA Inc. 23 PD-Rx Pharmaceuticals, Inc. 17 Glenmark Pharmaceuticals Inc., USA 15 Bryant Ranch Prepack 14 A-S Medication Solutions 11 Alembic Pharmaceuticals Limited 8 Alembic Pharmaceuticals Inc. 8 American Health Packaging 6 Camber Pharmaceuticals, Inc. 6 Boiron 4 Coupler LLC 4 ANI Pharmaceuticals, Inc. 3 AvKARE 3 Mylan Pharmaceuticals Inc. 3 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 3 Mylan Institutional Inc. 2 NCS HealthCare of KY, LLC dba Vangard Labs 2 Proficient Rx LP 2 Cardinal Health 107, LLC 2 Rising Pharma Holdings, Inc. 2 Rising Pharmaceuticals, Inc. 2 Sun Pharmaceutical Industries, Inc. 2 Preferred Pharmaceuticals, Inc. 1

…and 16 more on the FDA NDC directory.

🔬 Where this comes from

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 Nov 22, 2022
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Lithium Carbonate.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Lithium Carbonate after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
54
NDC products indexed
203
Distinct labelers/manufacturers represented
40
Linked representative label
Hikma Pharmaceuticals USA Inc.
Linked label effective
Nov 22, 2022
Composite sections available
22
Linked SPL Set ID
7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e
Linked SPL Document ID
a9e58e66-6569-4c3b-993f-b4236904296e
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 54 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Hikma Pharmaceuticals USA Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.