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Tranexamic Acid 1 g/10mL Injection, Solution — NDC 14593-0318-01 package photo

Tranexamic Acid 1 g/10mL Injection, Solution

by Emcure Pharmaceuticals Limited · 10 VIAL in 1 CARTON (14593-318-01) / 10 mL in 1 VIAL
NDC 14593-0318-01
🏷️ FDA NDC (as labeled) 14593-318-01 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

⚠️
Other active recalls for Tranexamic Acid (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class III · Jun 13, 2023 — Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. (AVKARE LLC) · FDA recall D-0875-2023
Class III · Sep 26, 2022 — Presence of Particulate Matter: Piece of metal found in a vial (AuroMedics Pharma LLC) · FDA recall D-1551-2022
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 14593-318-01
Product NDC 14593-318
11-digit billing NDC 14593031801
RxCUI 238720
UNII 6T84R30KC1
UPC 0314593318016
Application # ANDA203521
SPL Set ID ceea739a-21dd-4c3a-9ef6-2b7ab2bdd95a
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 2024-10-28
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance TRANEXAMIC ACID
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 14593-318-01 — 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 → 14593-0318-01. 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

LabelerEmcure Pharmaceuticals Limited
Application holderAVET LIFESCIENCES LTD
FDA applicationANDA203521 (ANDA)
Labeler code14593
First marketedOct 2024
Product typeHuman Prescription Drug
Portfolio77 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📗 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 →
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.

🧪 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 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

1 inactive ingredient 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 systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tranexamic Acid 1 g/10mL 23155-0166-41 Heritage 10 vials $0.387 AP Availability likely —
Tranexamic Acid 1 g/10mL 23155-0524-41 Heritage 10 vials $0.387 AP Availability likely —
Tranexamic Acid 100 mg/mL 23155-0910-41 Heritage 10 vials $0.387 AP Availability likely —
Tranexamic Acid 100 mg/mL 25021-0415-10 Sagent 10 vials $0.387 AP Availability likely —
Tranexamic Acid 100 mg/mL 39822-1000-01 XGen 10 vials $0.387 AP Availability likely —
Tranexamic Acid 100 mg/mL 43066-0008-10 Baxter 1 vial $0.387 AP Availability likely —
Tranexamic Acid 100 mg/mL 55150-0188-10 Eugia 10 vials $0.387 AP Availability likely —
Tranexamic Acid 100 mg/mL 60505-6169-01 Apotex 10 vials $0.387 AP Availability likely —
Tranexamic Acid 100 mg/mL 65145-0106-10 Caplin 10 vials $0.387 AP Availability likely —
Tranexamic Acid 100 mg/mL 67457-0197-10 Mylan 10 vials $0.387 AP Availability likely —
Tranexamic Acid 100 mg/mL 72485-0510-10 Armas 10 vials $0.387 AP Availability likely —
Tranexamic Acid 100 mg/mL 72603-0387-10 Northstar 10 vials $0.387 AP Availability likely —
tranexamic acid 100 mg/mL 81284-0611-10 Provepharm 10 vials $0.387 AP Availability likely —
tranexamic acid 100 mg/mL 81284-0612-10 Provepharm 10 vials $0.387 AP Availability likely —
tranexamic acid 100 mg/mL 83634-0401-10 Avenacy, 10 vials $0.387 AP Availability likely —
Cyklokapron 100 mg/mL 00013-1114-15 Pfizer 1 ampule — AP FDA listed —
Tranexamic Acid 100 mg/mL 00517-0960-01 American 1 vial — AP Discontinued —
Tranexamic Acid 1 g/10mLthis 14593-0318-01 Emcure 10 vials — AP FDA listed —
Tranexamic Acid 100 mg/mL 23155-0909-41 Heritage 10 ampules — AP FDA listed —
Tranexamic Acid 100 mg/mL 42571-0189-57 Micro 1 ampule — AP FDA listed —
Tranexamic Acid 100 mg/mL 42571-0314-89 Micro 1 vial — AP FDA listed —
Tranexamic Acid 100 mg/mL 51662-1532-01 HF 10 ml — AP FDA listed —
Tranexamic acid 100 mg/mL 68083-0160-10 Gland 10 vials — AP FDA listed —
Tranexamic Acid 100 mg/mL 70121-1398-01 Amneal 1 vial — AP FDA listed —
Tranexamic Acid 100 mg/mL 70518-4089-00 REMEDYREPACK 1 vial — AP FDA listed —
Tranexamic Acid 100 mg/mL 72485-0107-01 Armas 1 vial — AP 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
Oct 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 NDCDescription Marketing startStatus
14593-0318-01 You're viewing this 10 VIAL in 1 CARTON (14593-318-01) / 10 mL in 1 VIAL 2024-10-28 Active

🧭 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 14593-318-01, 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: 14593-0318-01, written without dashes as 14593031801. 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 14593-0318-01, the first segment (14593) is the labeler code FDA assigned to Emcure Pharmaceuticals Limited; the middle segment (0318) 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 Emcure Pharmaceuticals Limited. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Emcure Pharmaceuticals Limited 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
🎯 Indications and Usage 37 words ▾

INDICATIONS AND USAGE Tranexamic acid injection, USP is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 14539-0675-01 · Heritage 14593-0801-01 · Emcure →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.