NDC 71335-2695-01 — TRANEXAMIC ACID 650 mg Tablet, 8-count

🆔 Identity & classification

FDA NDC (as labeled) 71335-2695-1

Product NDC 71335-2695

11-digit billing NDC 71335269501

RxCUI 883826

UNII 6T84R30KC1

Application # ANDA218320

SPL Set ID 5b0c13fe-2c8e-4ac8-8bda-140881bd0cc4

Established class (EPC) Antifibrinolytic Agent

Physiologic effect Decreased Fibrinolysis

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2024-06-11

Route ORAL

Dosage form TABLET

Substance TRANEXAMIC ACID

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 71335-2695-1 — a 5-4-1 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 package segment → 71335-2695-01. 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 Antifibrinolytic Agent class.

Pharmacologic class Antifibrinolytic Agent

Drug family (ATC) Amino acids

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

LabelerBryant Ranch Prepack

Application holderRUBICON RESEARCH LTD

FDA applicationANDA218320 (ANDA)

Labeler code71335

First marketedJun 2024

Product typeHuman Prescription Drug

Portfolio4,433 products on file

🔎 All NDCs from Bryant Ranch Prepack

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

📖 What it is MedlinePlus · NLM

Tranexamic acid is used to treat heavy bleeding during the menstrual cycle (monthly periods) in women. Tranexamic acid is in a class of medications called antifibrinolytics. It works to improve blood clotting.

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

It depends on the form. As an IV injection, it's used short-term in people with hemophilia to control bleeding during and after a tooth extraction. As a tablet — brands include Lys...
What exactly is tranexamic acid used for?
No — this is a firm contraindication. Using tranexamic acid tablets at the same time as combined hormonal contraceptives (the pill, patch, or ring) significantly raises your risk o...
Can I take the tablets if I'm on the pill or another hormonal birth control?

📖 Read our full Tranexamic Acid guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Tranexamic Acid — tap one for details:

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

🌿 Every supplement checked against Tranexamic Acid (17 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

ShapeOval

ImprintA64;UpArrowhead

Size17 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 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 7Z8S9VYZ4B
Ethylcellulose is a plant-derived thickener and film-former made by chemically modifying cellulose. It's used as a binder to hold tablet ingredients together, a coating to control how quickly medicine is released, or a thickener in liquid formulations.
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 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 FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

7 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 each	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026	$1.81	$14.49 / 8 tablets

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Tranexamic Acid 650 mg 50268-0772-13	AvPAK	30 tablets	$0.857	AB	Availability likely	—
Tranexamic Acid 650 mg 59651-0839-30	Aurobindo	30 tablets	$0.857	AB	Availability likely	—
Tranexamic Acid 650 mg 60687-0750-21	American	30 tablets	$0.857	AB	Availability likely	—
Tranexamic Acid 650 mg 62559-0265-30	ANI	30 tablets	$0.857	AB	Availability likely	—
Tranexamic Acid 650 mg 69918-0301-30	Nordic	30 tablets	$0.857	AB	Availability likely	—
Tranexamic Acid 650 mg 75907-0309-30	Dr.	30 tablets	$0.857	AB	Availability likely	—
Tranexamic Acid 650 mg 00591-3720-10	Actavis	1000 tablets	—	AB	Discontinued	—
Tranexamic Acid 650 mg 63629-8599-01	Bryant	8 tablets	—	AB	FDA listed	—
Tranexamic Acid 650 mg 63629-8838-01	Bryant	30 tablets	—	AB	FDA listed	—
Tranexamic Acid 650 mg 71335-1981-01	Bryant	8 tablets	—	AB	FDA listed	—
Tranexamic Acid 650 mgthis 71335-2695-01	Bryant	8 tablets	—	AB	FDA listed	—
Tranexamic Acid 650 mg 72888-0178-01	ADVAGEN	100 tablets	—	AB	FDA listed	—
Tranexamic Acid 650 mg 82804-0208-15	Proficient	15 tablets	—	AB	FDA listed	—
Tranexamic Acid 650 mg 72319-0028-01	i3	30 tablets	—	AB	FDA listed	—
Tranexamic Acid 650 mg 72603-0818-01	NorthStar	30 tablets	—	AB	FDA listed	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2024

On the market since

Jun 2024

📍

2026

Currently FDA-listed

2 years listed

🔓

·

Generic on the market

this product is a generic

✅This is a generic drug

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

Where does this data come from?

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

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

Medicare Part D (outpatient prescription) spending for Tranexamic Acid — the program that covers self-administered drugs. 9 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 Tranexamic Acid. 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

$1.18M

Claims incl. refills

36.5K

Beneficiaries

33.4K

Spend / beneficiary

$35.38

Spend / claim

$32.37

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.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
71335-2695-01 You're viewing this	8 TABLET in 1 BOTTLE (71335-2695-1)	2025-09-24	Active
71335-2695-02	30 TABLET in 1 BOTTLE (71335-2695-2)	2025-09-24	Active
71335-2695-03	4 TABLET in 1 BOTTLE (71335-2695-3)	2025-09-24	Active

You're viewing one of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 71335-2695-01?

NDC 71335-2695-01 is a 8-count package — 8 tablet in 1 bottle.

What is the difference between NDC 71335-2695-01 and NDC 71335-2695-03?

Both are TRANEXAMIC ACID 650 mg Tablet — the drug itself is identical. NDC 71335-2695-01 is the 8-count package, while NDC 71335-2695-03 is the 4 tablets package.

What NDC number is used to bill for this package of TRANEXAMIC ACID 650 mg Tablet?

Bill NDC 71335-2695-01 — the 11-digit billing format is 71335269501. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	✓ Available
Inactive ingredients (structured)	✓ Available
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	✓ Available
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 71335-2695-1, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 71335-2695-01, written without dashes as 71335269501. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 71335-2695-01, the first segment (71335) is the labeler code FDA assigned to Bryant Ranch Prepack; the middle segment (2695) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Bryant Ranch Prepack. Listing status can change — the directory data on this page refreshes weekly.

Does this product come in other package sizes?

Yes — the FDA directory lists 2 other package presentations of this same product, including 4 tablets (71335-2695-03), 30 tablets (71335-2695-02). Each has its own NDC and its own page — see the package list near the top of this page.

Who lists this product with the FDA?

Bryant Ranch Prepack is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage 49 words ▾

1 INDICATIONS AND USAGE Tranexamic acid tablets are indicated for the treatment of cyclic heavy menstrual bleeding in females of reproductive potential [see Clinical Studies ( 14 )]. Tranexamic acid tablets are an antifibrinolytic indicated for the treatment of cyclic heavy menstrual bleeding in females of reproductive potential. (1)

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION 1,300 mg three times a day (3,900 mg/day) for a maximum of 5 days during monthly menstruation ( 2.1 ) Renal impairment : Lower dosage is needed (for a maximum of 5 days during menstruation) if serum creatinine concentration (Cr) is higher than 1.4 mg/dL ( 2.2 ) Cr above 1.4 mg/dL and ≤ 2.8 mg/dL: 1,300 mg two times a day (2,600 mg/day) Cr above 2.8 mg/dL and ≤ 5.7 mg/dL: 1,300 mg once a day (1,300 mg/day) Cr above 5.7 mg/dL: 650 mg once a day (650 mg/day)

2.1Recommended Testing Prior to Tranexamic Acid Tablets Administration Prior to prescribing tranexamic acid tablets, exclude endometrial pathology that can be associated with heavy menstrual bleeding.

2.2Recommended Dosage The recommended dosage of tranexamic acid tablets for patients with normal renal function is 1300 mg orally three times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation. Tranexamic acid tablets may be administered with or without food. Swallow tablets whole; do not chew or break apart.

2.3Dosage Recommendations in Patients with Renal Impairment The recommended dosage (for a maximum of 5 days during monthly menstruation) in patients with renal impairment with serum creatinine concentration higher than 1.4 mg/dL is described in Table 1. Table 1. Recommended Dosage of Tranexamic Acid Tablets in Patients with Renal Impairment Serum Creatinine (mg/dL) Recommended Dosage (maximum of 5 days during menstruation) Total Daily Dose Above 1.4 and ≤ 2.8 1300 mg two times a day 2600 mg Above 2.8 and ≤ 5.7 1300 mg once a day 1300 mg Above 5.7 650 mg once a day 650 mg

💊 Dosage Forms and Strengths 32 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets: 650 mg white to off white oval-shaped tablets debossed with A64 on one side and “˄” on the other side. Tablets: 650 mg ( 3 )

⛔ Contraindications 149 words ▾

4 CONTRAINDICATIONS Concomitant use of combined hormonal contraceptives ( 4.1 ) Active thromboembolic disease or a history or intrinsic risk of thrombosis or thromboembolism, including retinal vein or artery occlusion ( 4.1 ) Hypersensitivity to tranexamic acid ( 4.2 )

4.1Thromboembolic Risk Tranexamic acid tablets are contraindicated in females of reproductive potential who are [see Warnings and Precautions ( 5.1 )]: Using combined hormonal contraception Known to have any of the following conditions: Active thromboembolic disease (e.g., deep vein thrombosis, pulmonary embolism, or cerebral thrombosis) A history of thrombosis or thromboembolism, including retinal vein or artery occlusion An intrinsic risk of thrombosis or thromboembolism (e.g., thrombogenic valvular disease, thrombogenic cardiac rhythm disease, or hypercoagulopathy)

4.2Hypersensitivity to Tranexamic Acid Tranexamic acid tablets are contraindicated in females with reproductive potential with known hypersensitivity to tranexamic acid [see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.1 )].

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Thromboembolism, including retinal occlusion, has been reported with tranexamic acid tablets use. Concomitant use of tranexamic acid tablets with combined hormonal contraceptives, Factor IX complex concentrates, anti-inhibitor coagulant concentrates or all-trans retinoic acid (oral tretinoin) may increase the risk of thrombosis. ( 5.1 ) Visual or ocular adverse reactions may occur with tranexamic acid tablets.

Immediately discontinue use if visual or ocular symptoms occur. ( 5.1 ) In case of severe allergic reaction, discontinue tranexamic acid tablets and seek immediate medical attention. ( 5.2 ) Cerebral edema and cerebral infarction may be caused by use of tranexamic acid tablets in patients with subarachnoid hemorrhage.

( 5.3 ) Ligneous conjunctivitis has been reported in patients taking Tranexamic acid tablets. ( 5.4 )

5.1Thromboembolic Risk Venous and arterial thrombosis or thromboembolism, as well as cases of retinal artery and retinal vein occlusions, have been reported with tranexamic acid tablets. Retinal venous and arterial occlusion have been reported in patients using tranexamic acid tablets. Patients should be instructed to report visual and ocular symptoms promptly.

In the event of such symptoms, patients should be instructed to discontinue tranexamic acid tablets immediately and should be referred to an ophthalmologist for a complete ophthalmic evaluation, including dilated retinal examination, to exclude the possibility of retinal venous or arterial occlusion. Concomitant Use of Hormonal Contraceptives Combined hormonal contraceptives are known to increase the risk of venous thromboembolism, as well as arterial thromboses such as stroke and myocardial infarction. Because tranexamic acid tablets are antifibrinolytic, the risk of venous thromboembolism, as well as arterial thromboses such as stroke, may increase further when combined hormonal contraceptives are administered with tranexamic acid tablets.

This is of particular concern in women who are obese or smoke cigarettes, especially smokers over 35 years of age. Women using combined hormonal contraception were excluded from the clinical trials supporting the safety and efficacy of tranexamic acid tablets, and there are no clinical trial data on the risk of thrombotic events with the concomitant use of tranexamic acid tablets with combined hormonal contraceptives. However, there have been US postmarketing reports of venous and arterial thrombotic events in women who have used tranexamic acid tablets concomitantly with combined hormonal contraceptives.

For this reason, concomitant use of tranexamic acid tablets with combined hormonal contraceptives is contraindicated [see Contraindications ( 4.1 ) and Drug Interactions ( 7.1 )]. Concomitant Use with Factor IX Complex Concentrates or Anti-Inhibitor Coagulant Concentrates Tranexamic acid tablets are not recommended in patients taking either Factor IX complex concentrates or anti-inhibitor coagulant concentrates because the risk of thrombosis may be increased [see Drug Interactions ( 7.3 ) and Clinical Pharmacology ( 12.3 ) ].

Patients with Acute Promyelocytic Leukemia Taking Concomitant All-Trans Retinoic Acid (Oral Tretinoin) Tranexamic acid tablets are not recommended in patients with acute promyelocytic leukemia taking all-trans retinoic acid for remission induction because of possible exacerbation of the procoagulant effect of all-trans retinoic acid [see Drug Interactions ( 7.4 ) and Clinical Pharmacology ( 12.3 ) ].

5.2Severe Allergic Reactions A case of severe allergic reaction to tranexamic acid tablets was reported in the clinical trials, involving a subject who experienced dyspnea, tightening of her throat, and facial flushing that required emergency medical treatment. A case of anaphylactic shock has also been reported in the literature, involving a patient who received an intravenous bolus of tranexamic acid. Tranexamic acid tablets are contraindicated in females of repro…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Most common adverse reactions in clinical trials (≥ 5%, and more frequent in tranexamic acid tablets-treated subjects compared to placebo-treated subjects) are headache, sinus and nasal symptoms, back pain, abdominal pain, musculoskeletal pain, joint pain, muscle cramps, migraine, anemia and fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Advagen Pharma Ltd. at 866-488-0312 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trial 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 to the rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Adverse Reactions in Short-term Studies The safety of tranexamic acid tablets in the treatment of heavy menstrual bleeding in females of reproductive potential was studied in two randomized, double-blind, placebo-controlled studies [see Clinical Studies ( 14 ) ].

Study 1 compared the effects of two doses of tranexamic acid tablets (1950 mg and 3900 mg per day for up to 5 days during each menstrual period) versus placebo over a 3-cycle treatment duration. A total of 304 women were randomized to this study, with 115 receiving at least one dose of 3900 mg/day of tranexamic acid tablets. Study 2 compared the effects of tranexamic acid tablets (3900 mg/day) versus placebo over a 6-cycle treatment duration.

A total of 196 women were randomized to this study, with 117 receiving at least one dose of tranexamic acid tablets. Across the studies, the combined exposure to 3900 mg/day tranexamic acid tablets was 947 cycles and the average duration of use was 3.4 days per cycle. In both studies, subjects were generally healthy women who had menstrual blood loss of ≥ 80 mL.

In these studies, subjects were 18 to 49 years of age with a mean age of approximately 40 years, had cyclic menses every 21-35 days, and a body mass index (BMI) of approximately 32 kg/m 2 . On average, subjects had a history of heavy menstrual bleeding for approximately 10 years and 40% had fibroids as determined by transvaginal ultrasound. Approximately 70% were Caucasian, 25% were Black, and 5% were Asian, Native American, Pacific Islander, or Other.

Seven percent (7%) of all subjects were of Hispanic origin. Women using hormonal contraception were excluded from the trials. A list of adverse reactions occurring in ≥ 5% of subjects and more frequently in tranexamic acid tablets-treated subjects receiving 3900 mg/day compared to placebo-treated subjects is provided in Table 2.

Table 2. Adverse Reactions* Reported in Women with Heavy Menstrual Bleeding (Studies 1 and 2) Tranexamic Acid Tablets 3900 mg/day n (%) (N=232) Placebo n(%) (N=139) Number of Subjects with at Least One Adverse Reaction 208 (89.7%) 122 (87.8%) Headache a 117 (50.4%) 65 (46.8%) Nasal & sinus symptoms b 59 (25.4%) 24 (17.3%) Back pain 48 (20.7%) 21 (15.1%) Abdominal pain c 46 (19.8%) 25 (18.0%) Musculoskeletal pain d 26 (11.2%) 4 (2.9%) Arthralgia e 16 (6.9%) 7 (5.0%) Muscle cramps & spasms 15 (6.5%) 8 (5.8%) Migraine 14 (6.0%) 8 (5.8%) Anemia 13 (5.6%) 5 (3.6%) Fatigue 12 (5.2%) 6 (4.3%) * Adverse reactions that were reported by ≥ 5% of tranexamic acid tablets -treated subjects and more frequently in tranexamic acid tablets -treated subjects compared to placebo-treated subjects a Includes headache and tension headache b Nasal and sinus symptoms include nasal, respiratory tract and sinus congestion, sinusitis, acute sinusitis, sinus headache, allergic sinusitis and sinus pain, and multiple allergies and seasonal allergies c Abdominal pain includes abdominal tenderness and discomfort d Musculoskeletal pain includes musculoskeletal discomfort and myalgia e Arthralgia includes joint stiffness and swelling Adverse Reactions in Long-term Studies Long-term safety of tranexamic acid tablets was studied in two open-label studies.

In one study, subjects w…

🔄 Drug Interactions 213 words ▾

7 DRUG INTERACTIONS No drug-drug interaction studies were conducted with tranexamic acid tablets. Concomitant therapy with tissue plasminogen activators may decrease the efficacy of both tranexamic acid tablets and tissue plasminogen activators. ( 7.2 )

7.1Combined Hormonal Contraceptives Because tranexamic acid tablets are antifibrinolytic, concomitant use of combined hormonal contraception and tranexamic acid tablets may increase the thrombotic risk associated with combined hormonal contraceptives. For this reason, concomitant use of tranexamic acid tablets with combined hormonal contraceptives is contraindicated [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )].

7.2Tissue Plasminogen Activators Concomitant therapy with tissue plasminogen activators may decrease the efficacy of both tranexamic acid tablets and tissue plasminogen activators. Discontinue tranexamic acid tablets if a patient requires tissue plasminogen activators.

7.3Factor IX Complex Concentrates or Anti-Inhibitor Coagulant Concentrates Tranexamic acid tablets are not recommended in patients taking either Factor IX complex concentrates or anti-inhibitor coagulant concentrates because the risk of thrombosis may be increased [see Warnings and Precautions ( 5.1 )

7.4All-Trans Retinoic Acid (Oral Tretinoin) Tranexamic acid tablets are not recommended in patients with acute promyelocytic leukemia taking all-trans retinoic acid for remission induction because of possible exacerbation of the procoagulant effect of all-trans retinoic acid [ see Warnings and Precautions ( 5.1 )].

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Geriatric use: Tranexamic acid tablets are not indicated for use in postmenopausal women ( 8.5 ) Renal impairment: A lower dosage is needed. ( 2.2 , 8.6 ) Hepatic impairment: No dosage adjustment is needed. ( 8.7 )

8.1Pregnancy Risk Summary Tranexamic acid tablets are not indicated for use in pregnant women . There are no available data on tranexamic acid tablets use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Tranexamic acid crosses the placenta.

Animal reproduction studies have not identified adverse developmental outcomes with oral administration of tranexamic acid to pregnant rats at doses up to 4 times the recommended human dose (see Data ) . In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In a rat embryo-fetal developmental toxicity study, tranexamic acid had no adverse effects on embryo- fetal development when administered during the period of organogenesis (from gestation days 6 through 17) at twice daily doses of 0, 150, 375, and 750 mg/kg (1, 2 and 4 times the recommended human oral dosage of 3900 mg/day based on body surface area (mg/m 2 ).

In a perinatal-postnatal developmental toxicity study in rats administered tranexamic acid from gestation day 6 through postnatal day 20 at twice daily doses of 0, 150, 375, and 750 mg/kg, no significant adverse effects on maternal behavior or body weight were observed, and no significant effects on pup viability, body weight, developmental milestones or adult fertility were observed. It was concluded that the no- observed-effect-level (NOEL) for this study was 1500 mg/kg/day in both F 0 and F 1 generations, which is equivalent to 4 times the recommended human oral dose of 3900 mg/day based on body surface area (mg/m 2 ).

8.2Lactation Risk Summary Tranexamic acid is present in the mother’s milk at a concentration of about one hundredth of the corresponding serum concentration (see Data ). The amount of tranexamic acid a nursing infant would absorb is unknown. There are no adequate data on the effects of tranexamic acid on the breastfed infant or the effects of tranexamic acid on milk production.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for tranexamic acid tablets and any potential adverse effects on the breast-fed child from tranexamic acid tablets or from the underlying maternal condition. Data Human Data One hour after the last dose following a 2-day treatment course in lactating women, the milk concentration of the tranexamic acid was 1% of the peak serum concentration.

8.4Pediatric Use The safety and effectiveness of tranexamic acid tablets have been established in females of reproductive potential. Efficacy is expected to be the same for post-menarchal females under the age of 17 as for those 17 years and older. Tranexamic acid tablets are not indicated before menarche.

8.5Geriatric Use Tranexamic acid tablets are indicated for females of reproductive potential and is not intended for use by postmenopausal women.

8.6Renal Impairment The effect of renal impairment on the pharmacokinetics of tranexamic acid tablets has not been studied. Because tranexamic acid is primarily eliminated via the kidneys by glomerular filtration with more than 95% excreted as unchanged in urine, the recommended dosage in patient with renal impairment is lower than the recommended dosage in patients with normal renal function [see Dosage and Administration ( 2.2 ) and Clinical Pharmacology ( 12.3 ) ].

8.7Hepatic Impairment The effect of hepatic impairment on the pharmacokinetics of tranexamic acid tablets has not been studied. Because only a small fraction of the drug is metabolized, the recommended dosage in patients with hepatic impairment is the same as in pa…

🆘 Overdosage 115 words ▾

10 OVERDOSAGE There are no known cases of intentional overdose with tranexamic acid tablets and no subjects in the clinical program took more than 2 times the prescribed amount of tranexamic acid tablets in a 24-hour period (>7800 mg/day). However, cases of overdose of tranexamic acid have been reported. Based on these reports, symptoms of overdose may include gastrointestinal (nausea, vomiting, diarrhea); hypotensive (e.g., orthostatic symptoms); thromboembolic (arterial, venous, embolic); visual impairment; mental status changes; myoclonus; or rash.

No specific information is available on the treatment of overdose with tranexamic acid tablets. In the event of overdose, employ the usual supportive measures (e.g., clinical monitoring and supportive therapy) as dictated by the patient's clinical status.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Tranexamic acid is a synthetic lysine amino acid derivative, which diminishes the dissolution of hemostatic fibrin by plasmin. In the presence of tranexamic acid, the lysine receptor binding sites of plasmin for fibrin are occupied, preventing binding to fibrin monomers, thus preserving and stabilizing fibrin’s matrix structure. The antifibrinolytic effects of tranexamic acid are mediated by reversible interactions at multiple binding sites within plasminogen.

Native human plasminogen contains 4 to 5 lysine binding sites with low affinity for tranexamic acid (K d = 750 µmol/L) and 1 with high affinity (K d = 1.1 µmol/L). The high affinity lysine site of plasminogen is involved in its binding to fibrin. Saturation of the high affinity binding site with tranexamic acid displaces plasminogen from the surface of fibrin.

Although plasmin may be formed by conformational changes in plasminogen, binding to and dissolution of the fibrin matrix is inhibited.

12.2Pharmacodynamics Tranexamic acid, at in vitro concentrations of 25 - 100 µM, reduces by 20 - 60% the maximal rate of plasmin lysis of fibrin catalyzed by tissue plasminogen activator (tPA). Elevated concentrations of endometrial, uterine, and menstrual blood tPA are observed in women with heavy menstrual bleeding (HMB) compared to women with normal menstrual blood loss. The effect of tranexamic acid on lowering endometrial tPA activity and menstrual fluid fibrinolysis is observed in women with HMB receiving tranexamic acid tablets total oral doses of 2-3 g/day for 5 days.

In healthy subjects, tranexamic acid at blood concentrations less than 10 mg/mL has no effect on the platelet count, the coagulation time or various coagulation factors in whole blood or citrated blood. Tranexamic acid, however, at blood concentrations of 1 and 10 mg/mL prolongs the thrombin time. Cardiac Electrophysiology The effect of tranexamic acid tablets on QT interval was evaluated in a randomized, single-dose, 4-way crossover study in 48 healthy females aged 18 to 49 years.

Subjects received (1) tranexamic acid tablets 1300 mg (2) tranexamic acid tablets 3900 mg (three times the maximum recommended single dose), (3) moxifloxacin 400 mg, and (4) placebo. There was no significant increase in the corrected QT interval at any time up to 24 hours after the administration of either dose of tranexamic acid tablets. Moxifloxacin, the active control, was associated with a maximum 14.1 msec mean increase in corrected QT interval (moxifloxacin – placebo) at 3 hours after administration.

12.3Pharmacokinetics Absorption After a single oral administration of 1300 mg of tranexamic acid tablets, the peak plasma concentration (C max ) occurred at approximately 3 hours (T max ). The absolute bioavailability of tranexamic acid tablets in women aged 18-49 is approximately 45%. Following multiple oral doses (1300 mg tablets three times daily) administration of tranexamic acid tablets for 5 days, the mean C max increased by approximately 19% and the mean area under the plasma concentration-time curve (AUC) remained unchanged, compared to a single oral dose administration (1300 mg).

Plasma concentrations reached steady state at the 5 th dose of tranexamic acid tablets on Day 2. The mean plasma pharmacokinetic parameters of tranexamic acid determined in 19 healthy women following a single (1300 mg) and multiple (1300 mg tablets three times daily for 5 days) oral dose of tranexamic acid tablets are shown in Table 3. Table 3.

Mean (CV%) Pharmacokinetic Parameters Following a Single (1300 mg) and Multiple Dose (1300 mg three times daily for 5 days) Oral Administration of Tranexamic Acid Tablets in 19 Healthy Women under Fasting Conditions Parameter Arithmetic Mean (CV%) Single dose Multiple dose C max (mcg/mL) 13.83 (32.14) 16.41 (26.19) AUC tldc (mcg∙h/mL) 77.96 (31.14) 77.67 a (29.39) AUC inf (mcg∙h/mL) 80.19 (30.43) - T max (h) b 2.5 (1 – 5) 2.5 (2 – 3.5) t 1/2 (h) 11.08 (16.…

📦 How Supplied / Storage and Handling 80 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Tranexamic acid tablets, USP are provided as white to off white oval-shaped tablets debossed with A64 on one side and “˄” on the other side. NDC: 71335-2695-1: 8 TABLETs in a BOTTLE NDC: 71335-2695-2: 30 TABLETs in a BOTTLE NDC: 71335-2695-3: 4 TABLETs in a BOTTLE Store at room temperature 25° C (77° F); excursions permitted to 15-30° C (59-86° F). [See USP Controlled Room Temperature]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc.

Burbank, CA 91504

📋 Description 134 words ▾

11 DESCRIPTION Tranexamic acid tablets, USP are an antifibrinolytic drug administered orally. The chemical name is trans-4-aminomethyl-cyclohexanecarboxylic acid. The structural formula is: Tranexamic acid is a white crystalline powder.

It is freely soluble in water and in glacial acetic acid and is very slightly soluble in ethanol and practically insoluble in ether. The molecular formula is C 8 H 15 NO 2 and the molecular weight is 157.2. Tranexamic acid tablets are provided as white to off white oval-shaped tablets debossed with A64 on one side and “˄” on the other side.” The active ingredient in each tablet is 650 mg tranexamic acid.

The inactive ingredients contained in each tablet are: colloidal silicon dioxide, croscarmellose sodium, ethyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch and povidone. FDA approved dissolution test specifications differ from USP.

💬 Information for Patients 189 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Thromboembolic Risk Inform patients that tranexamic acid tablets may increase the risk of venous and arterial thrombosis or thromboembolism and to contact their healthcare provider for any signs or symptoms suggestive of thromboembolism [see Warnings and Precautions ( 5.1 )]. Advise patients to discontinue use of tranexamic acid tablets and promptly report visual and ocular symptoms to their health care provider as retinal venous and arterial occlusion have been reported in patients using tranexamic acid tablets [see Warnings and Precautions ( 5.1 )] .

Severe Allergic Reactions Inform patients that they should stop tranexamic acid tablets and seek immediate medical attention if they notice symptoms of a severe allergic reaction (e.g., shortness of breath or throat tightening) [see Warnings and Precautions ( 5.2 )] . Administration Instructions Instruct patients to take tranexamic acid tablets only during menstruation and for a maximum of 5 days each month [see Recommended Dosage ( 2.1 )] . Manufactured by: Rubicon Research Pvt Ltd., Thane 421506 India.

Distributed by: Advagen Pharma Ltd., East Windsor, NJ 08520, USA Revision: 05/2024

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.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

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

Active ingredient: The part of a medicine that produces its intended effect on the body.

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.

anemia: A low level of red blood cells or the oxygen-carrying protein inside them, which can cause tiredness, weakness, and paleness.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

arthralgia: Joint pain.

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

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

bolus: A single dose given all at once, often as a quick push into a vein.

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.

conjunctivitis: Redness and irritation of the thin lining over the white of the eye, often called pink eye.

contraception: Methods used to prevent pregnancy, such as birth control pills, condoms, or an intrauterine device.

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

crosses the placenta: When a substance passes from a pregnant mother's blood, through the placenta, and into the developing baby.

crossover: A study design in which each person takes one treatment for a time, then switches to the other, acting as their own comparison.

deep vein thrombosis: A blood clot that forms in a deep vein, usually in the leg, causing swelling and pain.

diarrhea: Loose, watery bowel movements that happen more often than normal.

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

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

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.

dyspnea: The medical word for shortness of breath, or the feeling that you cannot get enough air.

edema: Swelling caused by extra fluid trapped in the body's tissues.

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

embolism: A blockage of a blood vessel by a clot or other material that has traveled from elsewhere in the body.

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

fertility: The natural ability to become pregnant or to father a child.

flushing: Temporary redness and warmth of the skin, often on the face and neck, from widening of small blood vessels.

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.

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.

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

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

myalgia: Muscle pain or aching.

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

myoclonus: Sudden, brief, jerking movements of a muscle or group of muscles.

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

nursing infant: A baby who is being fed breast milk.

open-label: A study in which both the patients and their doctors know which treatment each person is receiving.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

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

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.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

pulmonary embolism: A blood clot that has traveled to the lungs and blocks blood flow there, which can make breathing hard.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

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

remission: A period when the signs and symptoms of cancer are reduced or have disappeared.

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

reproductive potential: The ability to have children, meaning a person who could become pregnant or could father a child.

serum creatinine: A waste product measured in a blood test; higher levels can mean the kidneys are not filtering as well as normal.

steady state: The point where the amount of medicine going in equals the amount leaving, so blood levels stay fairly even.

thromboembolism: A blood clot that forms in one place and travels through the bloodstream to block a vessel somewhere else.

thrombosis: The forming of a blood clot inside a blood vessel, which can block normal blood flow.

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

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 ↗

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