NDC 55111-0293-98 — Sumatriptan Succinate 100 mg Tablet, 27-count

🆔 Identity & classification

FDA NDC (as labeled) 55111-293-98

Product NDC 55111-293

11-digit billing NDC 55111029398

NCPDP billing unit EA — each (per item)

RxCUI 313160, 313161, 315223

UNII J8BDZ68989

Application # ANDA076847

SPL Set ID ac80d018-6abf-2e41-ddea-90b4ff9e9013

Established class (EPC) Serotonin-1b and Serotonin-1d Receptor Agonist

Mechanism of action Serotonin 1b Receptor Agonists; Serotonin 1d Receptor Agonists

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2009-11-17

Route ORAL

Dosage form TABLET

Substance SUMATRIPTAN SUCCINATE

GPI-14 67406070100320

GPI class SUMAtriptan Succinate

GCN Seq No 017129

GCN 05701

HICL code 006587

Ingredient (HICL) Sumatriptan Succinate

HIC1 code H

Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)

HIC2 code H3

Therapeutic class — intermediate (HIC2) Analgesics

HIC3 code H3F

Therapeutic class — specific (HIC3) Antimigraine Preparations

AHFS code 28:32.28.00

AHFS class Selective Serotonin Agonists

FDB label name SUMATRIPTAN SUCC 100 MG TABLET

FDB brand name Sumatriptan Succinate

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 55111-293-98 — 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 → 55111-0293-98. 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 Serotonin-1b and Serotonin-1d Receptor Agonist class.

Pharmacologic class Serotonin-1b and Serotonin-1d Receptor Agonist

Drug family (ATC) Selective serotonin (5HT1) agonists

How it works Serotonin 1b Receptor Agonists, Serotonin 1d Receptor 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.

🏭 Manufacturer & labeler

LabelerDr. Reddy's Laboratories Limited

Application holderDR REDDYS LABORATORIES INC

FDA applicationANDA076847 (ANDA)

Labeler code55111

First marketedNov 2009

Product typeHuman Prescription Drug

Portfolio200 products on file

🔎 All NDCs from Dr. Reddy's Laboratories Limited

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.

🩺 Clinical

Label name SUMATRIPTAN SUCC 100 MG TABLET Ingredient Sumatriptan Succinate

📖 What it is MedlinePlus · NLM

Sumatriptan is used to treat the symptoms of migraine headaches (severe, throbbing headaches that sometimes come with nausea or a strong reaction to sound and light). Sumatriptan is in a class of medications called selective serotonin receptor agonists. It works by narrowing blood vessels in the head, stopping pain signals from being sent to the brain, and stops the release of certain natural substances that cause pain, nausea, and other symptoms of migraines. Sumatriptan does not stop migraine attacks from coming or reduce the number of headaches you have.

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

Sumatriptan stops a migraine that's already started — it does not prevent future attacks. Think of it as a rescue medicine you take when a migraine hits, not something you take eve...
What exactly does sumatriptan do — does it prevent migraines or stop them?
Take it as soon as you're sure a migraine attack has started. Sumatriptan works by targeting the blood vessels and nerve pathways involved in the attack, so getting it on board ear...
When should I take it during a migraine attack?

📖 Read our full Sumatriptan guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Sumatriptan Succinate — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Sumatriptan Succinate (53 interactions) — ranked by severity →

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.

💊 What it looks like

Color White

ShapeCapsule

ImprintRDY;293

Size19 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII 3SY5LH9PMK
Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
UNII XHX3C3X673
Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.

9 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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.

💲 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 system	Per ea	Per package
Retail pharmacies payNADAC · weekly	$0.439	$11.85 / 27 tablets
Medicaid paysCMS SDUD · 12 mo	$1.25	$33.79 / 27 tablets
Medicare drug plans payPart D · Q2 2026	$0.8693	$23.47 / 27 tablets

NADAC price history (per ea) — tap or hover for the price & month

▼ Down 21% over the last 24 months.

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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Sumatriptan Succinate 100 mg 00378-5632-59	Mylan	9 tablets	$0.439	AB	Availability likely	—
Sumatriptan 100 mg 16714-0798-01	NorthStar	9 tablets	$0.439	AB	Availability likely	—
Sumatriptan Succinate 100 mgthis 55111-0293-98	Dr.	27 tablets	$0.439	AB	Availability likely	—
sumatriptan 100 mg 64980-0662-27	Rising	9 tablets	$0.439	AB	Availability likely	—
Sumatriptan Succinate 100 mg 65862-0148-36	Aurobindo	9 tablets	$0.439	—	Availability likely	—
Sumatriptan 100 mg 69452-0346-72	Bionpharma	9 tablets	$0.439	AB	Availability likely	—
Imitrex 100 mg 00173-0737-01	GlaxoSmithKline	9 tablets	$72.397	AB	Availability likely	+16400%
Sumatriptan 100 mg 50090-1130-00	A-S	9 tablets	—	AB	FDA listed	—
Sumatriptan Succinate 100 mg 51407-0013-09	Golden	9 tablets	—	AB	FDA listed	—
Sumatriptan 100 mg 55700-0899-09	Quality	9 tablets	—	AB	FDA listed	—
sumatriptan succinate 100 mg 62756-0522-01	Sun	9 tablets	—	—	FDA listed	—
Sumatriptan 100 mg 63187-0323-09	Proficient	9 tablets	—	—	FDA listed	—
Sumatriptan Succinate 100 mg 63187-0607-09	Proficient	81 tablets	—	AB	FDA listed	—
Sumatriptan 100 mg 63187-0931-09	Proficient	9 tablets	—	AB	FDA listed	—
Sumatriptan 100 mg 63304-0099-13	SUN	120 tablets	—	—	FDA listed	—
Sumatriptan Succinate 100 mg 68071-2283-09	NuCare	9 tablets	—	AB	FDA listed	—
Sumatriptan 100 mg 68071-3755-09	NuCare	9 tablets	—	AB	FDA listed	—
Sumatriptan 100 mg 68071-5072-09	NuCare	9 tablets	—	AB	FDA listed	—
Sumatriptan 100 mg 68788-6778-09	Preferred	9 tablets	—	AB	FDA listed	—
Sumatriptan 100 mg 68788-8535-09	Preferred	9 tablets	—	AB	FDA listed	—
Sumatriptan 100 mg 70518-1184-00	REMEDYREPACK	9 tablets	—	AB	FDA listed	—
sumatriptan succinate 50 mg 71205-0274-09	Proficient	1 tablet	—	—	FDA listed	—
Sumatriptan 100 mg 72189-0404-09	Direct_Rx	9 tablets	—	AB	FDA listed	—
Sumatriptan 100 mg 76420-0500-09	Asclemed	9 tablets	—	AB	FDA listed	—
Sumatriptan 100 mg 80425-0224-01	Advanced	9 tablets	—	AB	FDA listed	—
Sumatriptan 100 mg 80425-0258-01	Advanced	9 tablets	—	AB	FDA listed	—
Sumatriptan 100 mg 85766-0095-09	Sportpharm	9 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

🏛️

2009

On the market since

Nov 2009

📍

2026

Currently FDA-listed

17 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 55111-0293-98, not the drug overall. Other pack sizes report separately.

💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.

📅 Q1 2025 – Q1 2026 · 5 quarters of data

ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.

Prescriptions last 4 qtrs

114.8K

Units reimbursed last 4 qtrs

1.1M

Gross reimbursed last 4 qtrs

$1.35M

Avg / prescription

$11.75

Avg / unit

$1.2514

Latest quarter Q1 2026

25.6KRx

Medicaid pays / ea

$1.2514

gross reimbursed

vs

NADAC / ea

$0.4388

acquisition cost

=

Spread

+$0.8126

+185% vs cost

What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.

Fee-for-service vs managed care ⓘ

38% FFS 62% MCO

Fee-for-service · 43,719 Rx Managed care · 71,059 Rx

State Medicaid map

Units reimbursed · per 100k residents

21.01,096

gray = no data reported ⓘ

Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.

Tap or hover a state

…for its Medicaid breakdown

🏆 Top states by units · per 100k residents

1 Oregon 1,096 /100k

2 New Mexico 1,027 /100k

3 Kentucky 1,020 /100k

4 West Virginia 956 /100k

5 Colorado 855 /100k

6 Michigan 821 /100k

7 Utah 794 /100k

8 Ohio 788 /100k

National units — by quarter

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 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.

36 tablets55111-0293-36 145,657 Rx · $1,777,210

27 tablets this page55111-0293-98 114,778 Rx · $1,348,387

9 tablets55111-0293-09 1,064 Rx · $12,452

100 tablets55111-0293-01 No Medicaid data

500 tablets55111-0293-05 No Medicaid data

30 tablets55111-0293-30 No Medicaid data

90 tablets55111-0293-90 No Medicaid data

Drug total (last 4 qtrs): 261,499 Rx · 2,480,318 units · $3,138,049 gross reimbursed

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Sumatriptan Succinate — the program that covers self-administered drugs. 14 manufacturers.

⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Sumatriptan Succinate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.

Period

Total Part D spend

$11.61M

Claims incl. refills

488.6K

Beneficiaries

278K

Spend / beneficiary

$41.75

Spend / claim

$23.75

Trend by period

💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Sumatriptan Succinate — the ingredient across all brands.

Top reported reactions

Headache2,261

Nausea1,927

Migraine1,926

Fatigue1,560

Dizziness1,296

Pain1,242

Vomiting1,029

Reporter sex

Male · 17%

Female · 83%

Unknown · 0%

Serious outcomes

Hospitalization5,198

Disabling835

Death794

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Per unit	Per pack	Marketing start	Status
55111-0293-01	100 TABLET in 1 BOTTLE (55111-293-01)	—	—	2009-11-17	Active
55111-0293-05	500 TABLET in 1 BOTTLE (55111-293-05)	—	—	2009-11-17	Active
55111-0293-09	9 BLISTER PACK in 1 CARTON (55111-293-09) / 1 TABLET in 1 BLISTER PACK	$0.4388 / ea	$3.95	2009-11-17	Active
55111-0293-30	30 TABLET in 1 BOTTLE (55111-293-30)	—	—	2009-11-17	Active
55111-0293-36	36 TABLET in 1 BOTTLE (55111-293-36)	$0.4388 / ea	$15.80	2009-11-17	Active
55111-0293-90	90 TABLET in 1 BOTTLE (55111-293-90)	$0.4388 / ea	$39.49	2009-11-17	Active
55111-0293-98 You're viewing this	3 BLISTER PACK in 1 CARTON (55111-293-98) / 9 TABLET in 1 BLISTER PACK	$0.4388 / ea	$11.85	2020-12-10	Active

This pack effectively ties for the lowest per-ea cost of the 4 priced pack sizes ($0.4388 NADAC).

This pack accounts for about 44% of this product's recent Medicaid fills; most go to the 36 tablets pack. See all packs ↓

Pack size FAQ

What quantity is in NDC 55111-0293-98?

NDC 55111-0293-98 is a 27-count package — 3 blister pack in 1 carton / 9 tablet in 1 blister pack.

What is the difference between NDC 55111-0293-98 and NDC 55111-0293-09?

Both are Sumatriptan Succinate 100 mg Tablet — the drug itself is identical. NDC 55111-0293-98 is the 27-count package, while NDC 55111-0293-09 is the 9 tablets package.

What NDC number is used to bill for this package of Sumatriptan Succinate 100 mg Tablet?

Bill NDC 55111-0293-98 — the 11-digit billing format is 55111029398. 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.

📄 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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage 157 words ▾

1 INDICATIONS AND USAGE Sumatriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: • Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan tablets, reconsider the diagnosis of migraine before sumatriptan tablets are administered to treat any subsequent attacks. • Sumatriptan tablets are not indicated for the prevention of migraine attacks. • Safety and effectiveness of sumatriptan tablets have not been established for cluster headache.

Sumatriptan is a serotonin (5-HT 1B/1D ) receptor agonist (triptan) indicated for acute treatment of migraine with or without aura in adults. ( 1) Limitations of Use: Use only if a clear diagnosis of migraine headache has been established. ( 1 ) Not indicated for the prophylactic therapy of migraine attacks.

( 1 ) Not indicated for the treatment of cluster headache. ( 1 )

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION Single dose of 25 mg, 50 mg, or 100 mg tablet.( 2.1 ) A second dose should only be considered if some response to the first dose was observed. Separate doses by at least 2 hours. ( 2.1 ) Maximum dose in a 24 hour period: 200 mg. ( 2.1 ) Maximum single dose should not exceed 50 mg in patients with mild to moderate hepatic impairment. ( 2.2 )

2.1Dosing Information The recommended dose of sumatriptan tablets are 25 mg, 50 mg, or 100 mg. Doses of 50 mg and 100 mg may provide a greater effect than the 25 mg dose, but doses of 100 mg may not provide a greater effect than the 50 mg dose. Higher doses may have a greater risk of adverse reactions [see Clinical Studies (14 )].

If the migraine has not resolved by 2 hours after taking sumatriptan tablets, or returns after a transient improvement, a second dose may be administered at least 2 hours after the first dose. The maximum daily dose is 200 mg in a 24 hour period. Use after sumatriptan injection: If the migraine returns following an initial treatment with sumatriptan injection, additional single sumatriptan tablets (up to 100 mg/day) may be given with an interval of at least 2 hours between tablet doses.

The safety of treating an average of more than 4 headaches in a 30-day period has not been established.

2.2Dosing in Patients with Hepatic Impairment If treatment is deemed advisable in the presence of mild to moderate hepatic impairment, the maximum single dose should not exceed 50 mg [see Use in Specific Populations ( 8.6 ), Clinical Pharmacology ( 12.3 )].

💊 Dosage Forms and Strengths 122 words ▾

3 DOSAGE FORMS AND STRENGTHS 25 mg Tablets: White, round, biconvex film-coated tablets debossed with “RDY” on one side and “291” on the other side. Each tablet contains 35 mg of sumatriptan succinate, USP equivalent to 25 mg of sumatriptan. 50 mg Tablets: White, round, biconvex film-coated tablets debossed with “RDY” on one side and “292” on the other side.

Each tablet contains 70 mg of sumatriptan succinate, USP equivalent to 50 mg of sumatriptan. 100 mg Tablets: White, capsule shaped, biconvex film-coated tablets debossed with “RDY” on one side and “293” on the other side. Each tablet contains 140 mg of sumatriptan succinate, USP equivalent to 100 mg of sumatriptan.

Tablets: 25 mg, 50 mg, and 100 mg ( 3 )

⛔ Contraindications ~1 min read ▾

4 CONTRAINDICATIONS Sumatriptan tablets are contraindicated in patients with: • Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including Prinzmetal’s angina [see Warnings and Precautions ( 5.1 )] • Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see Warnings and Precautions ( 5.2 )] • History of stroke or transient ischemic attack (TIA) or history of hemiplegic or basilar migraine because these patients are at a higher risk of stroke [see Warnings and Precautions ( 5.4 )] • Peripheral vascular disease [see Warnings and Precautions ( 5.5 )] • Ischemic bowel disease [see Warnings and Precautions ( 5.5 )] • Uncontrolled hypertension [see Warnings and Precautions ( 5.8 )] • Recent use (i.e., within 24 hours) of ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), or another 5-hydroxytryptamine1 (5-HT 1 ) agonist [see Drug Interactions ( 7.1 , 7.3 )] • Concurrent administration of a monoamine oxidase (MAO)-A inhibitor or recent (within 2 weeks) use of an MAO-A inhibitor [see Drug Interactions ( 7.2 ), Clinical Pharmacology ( 12.3 )] • Hypersensitivity to sumatriptan (angioedema and anaphylaxis seen) [see Warnings and Precautions ( 5.9 )] • Severe hepatic impairment [see Use in Specific Populations ( 8.6 ), Clinical Pharmacology ( 12.3 )] History of coronary artery disease or coronary artery vasospasm ( 4 ) Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders ( 4 ) History of stroke, transient ischemic attack, or hemiplegic or basilar migraine ( 4 ) Peripheral vascular disease ( 4 ) Ischemic bowel disease ( 4 ) Uncontrolled hypertension ( 4 ) Recent (within 24 hours) use of another 5-HT 1 agonist (e.g., another triptan) or of an ergotamine-containing medication.

( 4 ) Concurrent or recent (past 2 weeks) use of monoamine oxidase-A inhibitor. ( 4 ) Hypersensitivity to sumatriptan (angioedema and anaphylaxis seen). ( 4 ) Severe hepatic impairment.

( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Myocardial ischemia/infarction and Prinzmetal’s angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors. ( 5.1 ) Arrhythmias: Discontinue sumatriptan if occurs. ( 5.2 ) Chest/throat/neck/jaw pain, tightness, pressure, or heaviness: Generally not associated with myocardial ischemia; evaluate for coronary artery disease in patients at high risk.

( 5.3 ) Cerebral hemorrhage, subarachnoid hemorrhage, and stroke: Discontinue sumatriptan if occurs. ( 5.4 ) Gastrointestinal ischemic reactions and peripheral vasospastic reactions: Discontinue sumatriptan if occurs. ( 5.5 ) Medication overuse headache: Detoxification may be necessary.

( 5.6 ) Serotonin syndrome: Discontinue sumatriptan if occurs. ( 5.7 ) Seizures: Use with caution in patients with epilepsy or a lowered seizure threshold. ( 5.10 )

5.1Myocardial Ischemia, Myocardial Infarction, and Prinzmetal’s Angina The use of sumatriptan tablets are contraindicated in patients with ischemic or vasospastic CAD. There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of sumatriptan tablets. Some of these reactions occurred in patients without known CAD.

Sumatriptan tablets may cause coronary artery vasospasm (Prinzmetal’s angina), even in patients without a history of CAD. Perform a cardiovascular evaluation in triptan-naive patients who have multiple cardiovascular risk factors (e.g., increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving sumatriptan tablets. If there is evidence of CAD or coronary artery vasospasm, sumatriptan tablets are contraindicated.

For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administering the first dose of sumatriptan tablets in a medically supervised setting and performing an electrocardiogram (ECG) immediately following administration of sumatriptan tablets. For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of sumatriptan tablets.

5.2Arrhythmias Life-threatening disturbances of cardiac rhythm, including ventricular tachycardia and ventricular fibrillation leading to death, have been reported within a few hours following the administration of 5-HT 1 agonists. Discontinue sumatriptan tablets if these disturbances occur. Sumatriptan tablets are contraindicated in patients with Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders.

5.3Chest, Throat, Neck, and/or Jaw Pain/Tightness/Pressure Sensations of tightness, pain, pressure, and heaviness in the precordium, throat, neck, and jaw commonly occur after treatment with sumatriptan tablets and are usually non-cardiac in origin. However, perform a cardiac evaluation if these patients are at high cardiac risk. The use of sumatriptan tablets are contraindicated in patients with CAD and those with Prinzmetal’s variant angina.

5.4Cerebrovascular Events Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT 1 agonists, and some have resulted in fatalities. In a number of cases, it appears possible that the cerebrovascular events were primary, the 5-HT 1 agonist having been administered in the incorrect belief that the symptoms experienced were a consequence of migraine when they were not. Also, patients with migraine may be at increased risk of certain cerebrovascular events (e.g., stroke, hemorrhage, TIA).

Discontinue sumatriptan tablets if a cerebrovascular event occurs. Before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with atypical symptoms, exclude other potentially serious neurological conditions. Sumatriptan tablets are contraindicated in patients with a history of stroke or TIA.

5.5 Other Vasospasm Reactions Sumatriptan tab…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the prescribing information: • Myocardial ischemia, myocardial infarction, and Prinzmetal’s angina [see Warnings and Precautions ( 5.1 )] • Arrhythmias [see Warnings and Precautions ( 5.2 )] • Chest, throat, neck, and/or jaw pain/tightness/pressure [see Warnings and Precautions ( 5.3 )] • Cerebrovascular events [see Warnings and Precautions ( 5.4 )] • Other vasospasm reactions [see Warnings and Precautions ( 5.5 )] • Medication overuse headache [see Warnings and Precautions ( 5.6 )] • Serotonin syndrome [see Warnings and Precautions ( 5.7 )] • Increase in blood pressure [see Warnings and Precautions ( 5.8 )] • Hypersensitivity reactions [see Contraindications (4 ), Warnings and Precautions ( 5.9 )] • Seizures [see Warnings and Precautions ( 5.10 )] Most common adverse reactions (≥2% and >placebo) were paresthesia, warm/cold sensation, chest pain/tightness/pressure and/or heaviness, neck/throat/jaw pain/tightness/pressure, other sensations of pain/pressure/tightness/heaviness, vertigo, and malaise/fatigue.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratories Inc. at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Table 1 lists adverse reactions that occurred in placebo-controlled clinical trials in patients who took at least 1 dose of study drug. Only treatment-emergent adverse reactions that occurred at a frequency of 2% or more in any group treated with sumatriptan tablets and that occurred at a frequency greater than the placebo group are included in Table 1.

Table 1. Adverse Reactions Reported by at Least 2% of Patients Treated with Sumatriptan Tablets and at a Greater Frequency than Placebo Percent of Patients Reporting Adverse Reaction Sumatriptan Tablets 25 mg (n = 417) Sumatriptan Tablets 50 mg (n = 771) Sumatriptan Tablets 100 mg (n = 437) Placebo (n = 309) Atypical sensations 5 6 6 4 Paresthesia (all types) 3 5 3 2 Sensation warm/cold 3 2 3 2 Pain and other pressure sensations Chest-pain/tightness/ pressure and/or heaviness Neck/throat/jaw-pain/ tightness/pressure Pain-location specified Other-pressure/tightness/ heaviness 6 1 <1 2 1 6 2 2 1 1 8 2 3 1 3 4 1 <1 1 2 Neurological Vertigo <1 <1 2 <1 Other Malaise/fatigue 2 2 3 <1 The incidence of adverse reactions in controlled clinical trials was not affected by gender or age of the patients.

There were insufficient data to assess the impact of race on the incidence of adverse reactions.

6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of sumatriptan tablets, sumatriptan nasal spray, and sumatriptan injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to sumatriptan or a combination of these factors.

Cardiovascular: Hypotension, palpitations. Neurological : Dystonia, tremor. Reproductive System and Breast Disorders Breast pain [see Use in Specific Populations (8.2) ].

🔄 Drug Interactions 141 words ▾

7 DRUG INTERACTIONS

7.1Ergot-Containing Drugs Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. Because these effects may be additive, use of ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) and sumatriptan tablets within 24 hours of each other is contraindicated.

7.2Monoamine Oxidase-A Inhibitors MAO-A inhibitors increase systemic exposure by 7-fold. Therefore, the use of sumatriptan tablets in patients receiving MAO-A inhibitors is contraindicated [see Clinical Pharmacology ( 12.3 )].

7.3Other 5-HT 1 Agonists Because their vasospastic effects may be additive, co administration of sumatriptan tablets and other 5-HT 1 agonists (e.g., triptans) within 24 hours of each other is contraindicated.

7.4Selective Serotonin Reuptake Inhibitors/Serotonin Norepinephrine Reuptake Inhibitors and Serotonin Syndrome Cases of serotonin syndrome have been reported during coadministration of triptans and SSRIs, SNRIs, TCAs, and MAO inhibitors [see Warnings and Precautions ( 5.7 )].

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm. (8.1)

8.1Pregnancy Risk Summary Data from a prospective pregnancy exposure registry and epidemiological studies of pregnant women have not detected an increased frequency of birth defects or a consistent pattern of birth defects among women exposed to sumatriptan compared with the general population ( see Data ). In developmental toxicity studies in rats and rabbits, oral administration of sumatriptan to pregnant animals was associated with embryolethality, fetal abnormalities, and pup mortality. When administered by the intravenous route to pregnant rabbits, sumatriptan was embryolethal ( see Data ).

In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The reported rate of major birth defects among deliveries to women with migraine ranged from 2.2% to 2.9% and the reported rate of miscarriage was 17%, which were similar to rates reported in women without migraine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk: Several studies have suggested that women with migraine may be at increased risk of preeclampsia during pregnancy.

Data Human Data : The Sumatriptan/Naratriptan/TREXIMET (sumatriptan and naproxen sodium) Pregnancy Registry, a population-based international prospective study, collected data for sumatriptan from January 1996 to September 2012. The Registry documented outcomes of 626 infants and fetuses exposed to sumatriptan during pregnancy (528 with earliest exposure during the first trimester, 78 during the second trimester, 16 during the third trimester, and 4 unknown). The occurrence of major birth defects (excluding fetal deaths and induced abortions without reported defects and all spontaneous pregnancy losses) during first-trimester exposure to sumatriptan was 4.2% (20/478 [95% CI: 2.6% to 6.5%]) and during any trimester of exposure was 4.2% (24/576 [95% CI: 2.7% to 6.2%]).

The sample size in this study had 80% power to detect at least a 1.73-to 1.91-fold increase in the rate of major malformations. The number of exposed pregnancy outcomes accumulated during the registry was insufficient to support definitive conclusions about overall malformation risk or for making comparisons of the frequencies of specific birth defects. Of the 20 infants with reported birth defects after exposure to sumatriptan in the first trimester, 4 infants had ventricular septal defects, including one infant who was exposed to both sumatriptan and naratriptan, and 3 infants had pyloric stenosis.

No other birth defect was reported for more than 2 infants in this group. In a study using data from the Swedish Medical Birth Register, live births to women who reported using triptans or ergots during pregnancy were compared with those of women who did not. Of the 2,257 births with first-trimester exposure to sumatriptan, 107 infants were born with malformations (relative risk 0.99 [95% CI: 0.91 to 1.21]).

A study using linked data from the Medical Birth Registry of Norway to the Norwegian Prescription Database compared pregnancy outcomes in women who redeemed prescriptions for triptans during pregnancy, as well as a migraine disease comparison group who redeemed prescriptions for sumatriptan before pregnancy only, compared with a population control group. Of the 415 women who redeemed prescriptions for sumatriptan during the first trimester, 15 had infants with major congenital malformations (OR 1.16 [95% CI: 0.69 to 1.94]) while for the 364 women who redeemed prescriptions for sumatriptan before, but not during, pregnancy, 20 had infants with major congenital malformations (OR 1.83 [95% CI: 1.17 to 2.88]), each compared with the population comparison group.

Additional smaller observational studies evaluating use of sumatriptan during pregnancy have not suggested an increased risk of teratogenicity. Ani…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Data from a prospective pregnancy exposure registry and epidemiological studies of pregnant women have not detected an increased frequency of birth defects or a consistent pattern of birth defects among women exposed to sumatriptan compared with the general population ( see Data ). In developmental toxicity studies in rats and rabbits, oral administration of sumatriptan to pregnant animals was associated with embryolethality, fetal abnormalities, and pup mortality. When administered by the intravenous route to pregnant rabbits, sumatriptan was embryolethal ( see Data ).

In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The reported rate of major birth defects among deliveries to women with migraine ranged from 2.2% to 2.9% and the reported rate of miscarriage was 17%, which were similar to rates reported in women without migraine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk: Several studies have suggested that women with migraine may be at increased risk of preeclampsia during pregnancy.

Data Human Data : The Sumatriptan/Naratriptan/TREXIMET (sumatriptan and naproxen sodium) Pregnancy Registry, a population-based international prospective study, collected data for sumatriptan from January 1996 to September 2012. The Registry documented outcomes of 626 infants and fetuses exposed to sumatriptan during pregnancy (528 with earliest exposure during the first trimester, 78 during the second trimester, 16 during the third trimester, and 4 unknown). The occurrence of major birth defects (excluding fetal deaths and induced abortions without reported defects and all spontaneous pregnancy losses) during first-trimester exposure to sumatriptan was 4.2% (20/478 [95% CI: 2.6% to 6.5%]) and during any trimester of exposure was 4.2% (24/576 [95% CI: 2.7% to 6.2%]).

The sample size in this study had 80% power to detect at least a 1.73-to 1.91-fold increase in the rate of major malformations. The number of exposed pregnancy outcomes accumulated during the registry was insufficient to support definitive conclusions about overall malformation risk or for making comparisons of the frequencies of specific birth defects. Of the 20 infants with reported birth defects after exposure to sumatriptan in the first trimester, 4 infants had ventricular septal defects, including one infant who was exposed to both sumatriptan and naratriptan, and 3 infants had pyloric stenosis.

No other birth defect was reported for more than 2 infants in this group. In a study using data from the Swedish Medical Birth Register, live births to women who reported using triptans or ergots during pregnancy were compared with those of women who did not. Of the 2,257 births with first-trimester exposure to sumatriptan, 107 infants were born with malformations (relative risk 0.99 [95% CI: 0.91 to 1.21]).

A study using linked data from the Medical Birth Registry of Norway to the Norwegian Prescription Database compared pregnancy outcomes in women who redeemed prescriptions for triptans during pregnancy, as well as a migraine disease comparison group who redeemed prescriptions for sumatriptan before pregnancy only, compared with a population control group. Of the 415 women who redeemed prescriptions for sumatriptan during the first trimester, 15 had infants with major congenital malformations (OR 1.16 [95% CI: 0.69 to 1.94]) while for the 364 women who redeemed prescriptions for sumatriptan before, but not during, pregnancy, 20 had infants with major congenital malformations (OR 1.83 [95% CI: 1.17 to 2.88]), each compared with the population comparison group.

Additional smaller observational studies evaluating use of sumatriptan during pregnancy have not suggested an increased risk of teratogenicity. Animal Data : Oral administration of sumatriptan to pregnant rats during the period of organog…

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established. Sumatriptan tablets are not recommended for use in patients younger than 18 years of age. Two controlled clinical trials evaluated sumatriptan nasal spray (5 to 20 mg) in 1,248 adolescent migraineurs aged 12 to 17 years who treated a single attack.

The trials did not establish the efficacy of sumatriptan nasal spray compared with placebo in the treatment of migraine in adolescents. Adverse reactions observed in these clinical trials were similar in nature to those reported in clinical trials in adults. Five controlled clinical trials (2 single-attack trials, 3 multiple-attack trials) evaluating oral sumatriptan (25 to 100 mg) in pediatric patients aged 12 to 17 years enrolled a total of 701 adolescent migraineurs.

These trials did not establish the efficacy of oral sumatriptan compared with placebo in the treatment of migraine in adolescents. Adverse reactions observed in these clinical trials were similar in nature to those reported in clinical trials in adults. The frequency of all adverse reactions in these patients appeared to be both dose-and age-dependent, with younger patients reporting reactions more commonly than older adolescents.

Postmarketing experience documents that serious adverse reactions have occurred in the pediatric population after use of subcutaneous, oral, and/or intranasal sumatriptan. These reports include reactions similar in nature to those reported rarely in adults, including stroke, visual loss, and death. A myocardial infarction has been reported in a 14-year-old male following the use of oral sumatriptan; clinical signs occurred within 1 day of drug administration.

Clinical data to determine the frequency of serious adverse reactions in pediatric patients who might receive subcutaneous, oral, or intranasal sumatriptan are not presently available.

🧓 Geriatric Use 121 words ▾

8.5Geriatric Use Clinical trials of sumatriptan tablets did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.

A cardiovascular evaluation is recommended for geriatric patients who have other cardiovascular risk factors (e.g., diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving sumatriptan tablets [see Warnings and Precautions ( 5.1 )].

🆘 Overdosage 120 words ▾

10 OVERDOSAGE Patients in clinical trials (N = 670) received single oral doses of 140 to 300 mg without significant adverse reactions. Volunteers (N = 174) received single oral doses of 140 to 400 mgwithout serious adverse reactions. Overdose in animals has been fatal and has been heralded by convulsions, tremor, paralysis, inactivity, ptosis, erythema of the extremities, abnormal respiration, cyanosis, ataxia, mydriasis, salivation, and lacrimation.

The elimination half-life of sumatriptan is approximately 2.5 hours [see Clinical Pharmacology ( 12.3 )], and therefore monitoring of patients after overdose with sumatriptan tablets should continue for at least 12 hours or while symptoms or signs persist. It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentrations of sumatriptan.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Sumatriptan binds with high affinity to human cloned 5-HT 1B/1D receptors. Sumatriptan presumably exerts its therapeutic effects in the treatment of migraine headache through agonist effects at the 5-HT 1B/1D receptors on intracranial blood vessels and sensory nerves of the trigeminal system, which result in cranial vessel constriction and inhibition of pro-inflammatory neuropeptide release.

12.2Pharmacodynamics Blood Pressure Significant elevation in blood pressure, including hypertensive crisis, has been reported in patients with and without a history of hypertension [see Warnings and Precautions ( 5.8 )]. Peripheral (Small) Arteries In healthy volunteers (N = 18), a trial evaluating the effects of sumatriptan on peripheral (small vessel) arterial reactivity failed to detect a clinically significant increase in peripheral resistance. Heart Rate Transient increases in blood pressure observed in some patients in clinical trials carried out during sumatriptan’s development as a treatment for migraine were not accompanied by any clinically significant changes in heart rate.

12.3Pharmacokinetics Absorption The mean maximum concentration following oral dosing with 25 mg is 18 ng/mL (range: 7 to 47 ng/mL) and 51 ng/mL (range: 28 to 100 ng/mL) following oral dosing with 100 mg of sumatriptan. This compares with a C max of 5 and 16 ng/mL following dosing with a 5 and 20 mg intranasal dose, respectively. The mean C max following a 6 mg subcutaneous injection is 71 ng/mL (range: 49 to 110 ng/mL).

The bioavailability is approximately 15%, primarily due to presystemic metabolism and partly due to incomplete absorption. The C max is similar during a migraine attack and during a migraine-free period, but the T max is slightly later during the attack, approximately 2.5 hours compared with 2 hours. When given as a single dose, sumatriptan displays dose proportionality in its extent of absorption (area under the curve [AUC]) over the dose range of 25 to 200 mg, but the C max after 100 mg is approximately 25% less than expected (based on the 25 mg dose).

Effect of Food: A food effect trial involving administration of sumatriptan tablets 100 mg to healthy volunteers under fasting conditions and with a high-fat meal indicated that the C max and AUC were increased by 15% and 12%, respectively, when administered in the fed state. Distribution Protein binding, determined by equilibrium dialysis over the concentration range of 10 to 1,000 ng/mL is low, approximately 14% to 21%. The effect of sumatriptan on the protein binding of other drugs has not been evaluated.

The apparent volume of distribution is

2.7L/kg. Metabolism In vitro studies with human microsomes suggest that sumatriptan is metabolized by MAO, predominantly the A isoenzyme. Most of a radiolabeled dose of sumatriptan excreted in the urine is the major metabolite indole acetic acid (IAA) or the IAA glucuronide, both of which are inactive.

Elimination The elimination half-life of sumatriptan is approximately 2.5 hours. Radiolabeled 14 C-sumatriptan administered orally is largely renally excreted (about 60%) with about 40% found in the feces. Most of the radiolabeled compound excreted in the urine is the major metabolite, IAA, which is inactive, or the IAA glucuronide.

Only 3% of the dose can be recovered as unchanged sumatriptan. Specific Populations Age : The pharmacokinetics of sumatriptan in the elderly (mean age: 72 years, 2 males and 4 females) and in subjects with migraine (mean age: 38 years, 25 males and 155 females) were similar to that in healthy male subjects (mean age: 30 years). Patients with Renal Impairment: The effect of renal impairment on the pharmacokinetics of sumatriptan has not been examined.

Patients with Hepatic Impairment : The liver plays an important role in the presystemic clearance of orally administered sumatriptan. Accordingly, the bioavailability of sumatriptan following oral administration may be markedl…

🧬 Mechanism of Action 58 words ▾

12.1Mechanism of Action Sumatriptan binds with high affinity to human cloned 5-HT 1B/1D receptors. Sumatriptan presumably exerts its therapeutic effects in the treatment of migraine headache through agonist effects at the 5-HT 1B/1D receptors on intracranial blood vessels and sensory nerves of the trigeminal system, which result in cranial vessel constriction and inhibition of pro-inflammatory neuropeptide release.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Sumatriptan tablets USP, 25, 50, and 100 mg of sumatriptan (base) as the succinate. Sumatriptan tablets USP, 25 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “291” on the other side. The tablets are supplied in bottles of 30, 36, 90, 100, 500 and unit of use blister pack of 9’s and 27's.

Bottles of 30 NDC 55111-291-30 Bottles of 36 NDC 55111-291-36 Bottles of 90 NDC 55111-291-90 Bottles of 100 NDC 55111-291-01 Bottles of 500 NDC 55111-291-05 Unit of use blister pack of 9 (1 x 9) NDC 55111-291-09 Unit of use blister pack of 27(3 x 9) NDC 55111-291-98 Sumatriptan tablets USP, 50 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “292” on the other side. The tablets are supplied in bottles of 30, 36, 90, 100, 500 and unit of use blister pack of 9’s and 27's. Bottles of 30 NDC 55111-292-30 Bottles of 36 NDC 55111-292-36 Bottles of 90 NDC 55111-292-90 Bottles of 100 NDC 55111-292-01 Bottles of 500 NDC 55111-292-05 Unit of use blister pack of 9 (1 x 9) NDC 55111-292-09 Unit of use blister pack of 27(3 x 9) NDC 55111-292-98 Sumatriptan tablets USP, 100 mg are white, capsule shaped, biconvex film-coated tablets debossed with “RDY” on one side and “293” on the other side.

The tablets are supplied in bottles of 30, 36, 90, 100, 500 and unit of use blister pack of 9’s and 27's. Bottles of 30 NDC 55111-293-30 Bottles of 36 NDC 55111-293-36 Bottles of 90 NDC 55111-293-90 Bottles of 100 NDC 55111-293-01 Bottles of 500 NDC 55111-293-05 Unit of use blister pack of 9 (1 x 9) NDC 55111-293-09 Unit of use blister pack of 27(1 x 9) NDC 55111-293-98 Store at 20° to 25°C (68°to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

📋 Description 130 words ▾

11 DESCRIPTION Sumatriptan tablets USP contain sumatriptan succinate, a selective 5-HT 1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure: The molecular formula is C 14 H 21 N 3 O 2 S•C 4 H 6 O 4 , representing a molecular weight of 413.5. Sumatriptan succinate USP is a white or almost white powder that is freely soluble in water, sparingly soluble in methanol, practically inso luble in methylene chloride.

Each sumatriptan tablet USP for oral administration contains 35, 70, or 140 mg of sumatriptan succinate USP equivalent to 25, 50, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, lactose anhydrous, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, talc, titanium dioxide and triacetin.

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Risk of Myocardial Ischemia and/or Infarction, Prinzmetal’s Angina, Other Vasospasm-Related Events, Arrhythmias, and Cerebrovascular Events Inform patients that sumatriptan tablets may cause serious cardiovascular side effects such as myocardial infarction or stroke. Although serious cardiovascular events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, irregular heartbeat, significant rise in blood pressure, weakness, and slurring of speech, and should ask for medical advice if any indicative sign or symptoms are observed.

Apprise patients of the importance of this follow-up [see Warnings and Precautions ( 5.1 , 5.2 , 5.4 , 5.5 , 5.8 )]. Anaphylactic/Anaphylactoid Reactions Inform patients that anaphylactic/anaphylactoid reactions have occurred in patients receiving sumatriptan tablets. Such reactions can be life-threatening or fatal.

In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens [see Contraindications ( 4 ), Warnings and Precautions ( 5.9 )]. Concomitant Use With Other Triptans or Ergot Medications Inform patients that use of sumatriptan tablets within 24 hours of another triptan or an ergot-type medication (including dihydroergotamine or methysergide) is contraindicated [see Contraindications ( 4 ), Drug Interactions ( 7.1 , 7.3 )]. Serotonin Syndrome Caution patients about the risk of serotonin syndrome with the use of sumatriptan tablets or other triptans, particularly during combined use with SSRIs, SNRIs, TCAs, and MAO inhibitors [see Warnings and Precautions ( 5.7 ), Drug Interactions ( 7.4 )].

Medication Overuse Headache Inform patients that use of acute migraine drugs for 10 or more days per month may lead to an exacerbation of headache and encourage patients to record headache frequency and drug use (e.g., by keeping a headache diary) [see Warnings and Precautions ( 5.6 )]. Pregnancy Advise patients to notify their healthcare provider if they become pregnant during treatment or plan to become pregnant [see Use in Specific Populations (8.1) ]. Lactation Advise breastfeeding women that they may develop transient breast pain when taking sumatriptan tablets.

Advise breastfeeding women that avoiding breastfeeding for 12 hours after treatment with sumatriptan can minimize their infant’s exposure to sumatriptan [see Use in Specific Populations (8.2) ]. Ability to Perform Complex Tasks Treatment with sumatriptan tablets may cause somnolence and dizziness; instruct patients to evaluate their ability to perform complex tasks after administration of sumatriptan tablets. Rx only Manufactured by: Dr.

Reddy’s Laboratories Limited Bachupally – 500 090 INDIA Revised: 01/2026

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

exacerbation: A flare-up or worsening of a condition.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agonist: A substance that switches on a specific target in the body to produce an effect, the way a key turns a lock.

anaphylaxis: A sudden, severe, whole-body allergic reaction that can cause trouble breathing, swelling, and a drop in blood pressure, needing emergency care.

angina pectoris: Chest pain or a squeezing feeling that happens when the heart muscle does not get enough blood and oxygen.

angioedema: Rapid swelling deep under the skin, often around the eyes, lips, tongue, or throat.

ataxia: Loss of muscle coordination that makes walking, balance, and controlled movements clumsy or unsteady.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

aura: A warning sensation, such as flashing lights or a strange smell, that can come before a migraine or seizure.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

cyanosis: A bluish color of the skin, lips, or nails caused by too little oxygen in the blood.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dystonia: Involuntary muscle contractions that cause twisting movements or abnormal, sometimes painful, body postures.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

electrocardiogram: A quick, painless test that records the heart's electrical activity to check its rhythm and rate.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

erythema: Redness of the skin caused by increased blood flow, often from irritation or inflammation.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

food effect: A change in how much or how fast a medicine is absorbed when it is taken with food.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hemodialysis: A treatment that uses a machine to filter waste and extra fluid from the blood when the kidneys cannot.

hemorrhage: Bleeding, especially heavy or uncontrolled bleeding, either inside the body or from an outside wound.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hypertensive crisis: A dangerous, sudden rise in blood pressure to very high levels.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

ischemia: Reduced blood flow to a part of the body, so that area does not get enough oxygen.

lactation: The making and release of milk from a mother's breasts after giving birth.

malaise: A general feeling of being unwell, uneasy, or low on energy, without one clear symptom.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

metabolite: A new substance formed when the body breaks a medicine down.

mydriasis: Widening of the pupil, the dark center of the eye.

myocardial infarction: The medical term for a heart attack, when blood flow to part of the heart muscle is blocked.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

palpitations: The feeling that your heart is racing, pounding, fluttering, or skipping beats.

paresthesia: A tingling, prickling, or "pins and needles" feeling in the skin, often in the hands or feet.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

Pregnancy Exposure Registry: A study that collects health information from women who took a medicine while pregnant to learn how safe it is.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

protein binding: How much of a medicine sticks to proteins in the blood instead of moving freely through the body.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

relative risk: A number comparing the chance of an event in one group with the chance of that same event in another group.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

Rx only: A label marking meaning the medicine can be obtained only with a prescription from a licensed health professional.

seizure: A sudden burst of abnormal electrical activity in the brain that can cause shaking, staring, confusion, or loss of awareness.

serotonin syndrome: A potentially dangerous reaction from too much of the brain chemical serotonin, causing agitation, fast heartbeat, sweating, and muscle twitching.

somnolence: Feeling very sleepy or drowsy, with trouble staying awake during the day.

subcutaneous: An injection placed into the fatty layer just under the skin; often written as subcut or SC.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

TIA: A brief, stroke-like episode from a temporary drop in blood flow to the brain, with symptoms that go away.

transient ischemic attack: A brief, stroke-like episode from a temporary drop in blood flow to the brain, with symptoms that go away.

treatment-emergent: Describes a side effect that first appears, or gets worse, after a person starts taking a treatment.

tremor: Shaking or trembling of part of the body, such as the hands, that a person cannot control.

trimester: One of the three roughly three-month stages that a pregnancy is divided into.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

ventricular fibrillation: A life-threatening, chaotic rhythm in the heart's lower chambers that stops the heart from pumping blood effectively.

vertigo: A spinning sensation that makes you feel like you or the room around you is moving.

volume of distribution: A calculated value showing how widely a medicine spreads into body tissues versus staying in the blood.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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

🔗 Related NDC lookups

🧪 All Sumatriptan Succinate NDCsSame ingredient 🏭 All Dr. labeler NDCsLabeler code 55111 📚 All Serotonin-1b and Serotonin-1d Receptor Agonist NDCsDrug class

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Antimigraine Preparations.

Naratriptan Hcl 00054-0278-03 Rizatriptan Benzoate 00093-7471-43 Dihydroergotamine Mesylate 00143-9273-10 Sumatriptan 00173-0523-00 Ergotamine Tartrate/Caffeine 00713-0166-12 Diclofenac Potassium 13668-0672-64 Zolmitriptan 16571-0803-16 Ergotamine Tartrate 70720-0120-20

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.