Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Tranexamic Acid 1 g/10mL Injection, Solution — NDC 14593-318-01 (Billing 14593-0318-01)
by Emcure Pharmaceuticals Limited · 10 VIAL in 1 CARTON / 10 mL in 1 VIAL
This is a package of Tranexamic Acid 1 g/10mL Injection, Solution from Emcure Pharmaceuticals Limited, marketed since Oct 2024 and currently FDA-listed. It is this product's only package size.
NDC 14593-0318-01
🏷️ FDA NDC (as labeled)
14593-318-01
billing pads the product segment with a zero
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
NDC database record
One package, one record: these facts belong to NDC 14593-318-01 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 14593 labeler · 318 product · 01 package
- Package marketed since
- Oct 28, 2024
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC)
- 0314593318016
- FDA record last changed
- Jul 24, 2026
⚠️
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
Regulatory identifiers FDA, NLM and CMS codes for this package
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
Quick answers
- RxCUI (RxNorm): 238720
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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
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.
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
📗 Our plain-language guide HelloPharmacist
- It depends on the form you've been prescribed. If you're taking it as a tablet (brand name Lysteda, or a generic), it's to treat heavy menstrual bleeding — you take it only during...
- What exactly is tranexamic acid used for?
- No — this is one of the most important things to know. Taking tranexamic acid tablets together with combined hormonal contraceptives (the pill, patch, or ring) is contraindicated,...
- Can I take tranexamic acid tablets with my birth control pill?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Tranexamic Acid — tap one for details:
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.
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
💬 Questions about Tranexamic Acid?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 mL | 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 · 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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 8, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 14593-0318-01 You're viewing this Main listing | 10 VIAL in 1 CARTON / 10 mL in 1 VIAL | 2024-10-28 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Tranexamic Acid 1 g/10mL 23155-0166-41 | Heritage | 10 vials | $0.404 | AP | Availability likely | — |
| Tranexamic Acid 1 g/10mL 23155-0524-41 | Heritage | 10 vials | $0.404 | AP | Availability likely | — |
| Tranexamic Acid 100 mg/mL 23155-0910-41 | Heritage | 10 vials | $0.404 | AP | Availability likely | — |
| Tranexamic Acid 100 mg/mL 25021-0415-10 | Sagent | 10 vials | $0.404 | AP | Availability likely | — |
| Tranexamic Acid 100 mg/mL 39822-1000-01 | XGen | 10 vials | $0.404 | AP | Availability likely | — |
| Tranexamic Acid 100 mg/mL 43066-0008-10 | Baxter | 1 vial | $0.404 | AP | Availability likely | — |
| Tranexamic Acid 100 mg/mL 55150-0188-10 | Eugia | 10 vials | $0.404 | AP | Availability likely | — |
| Tranexamic Acid 100 mg/mL 60505-6169-01 | Apotex | 10 vials | $0.404 | AP | Availability likely | — |
| Tranexamic Acid 100 mg/mL 65145-0106-10 | Caplin | 10 vials | $0.404 | AP | Availability likely | — |
| Tranexamic Acid 100 mg/mL 67457-0197-10 | Mylan | 10 vials | $0.404 | AP | Availability likely | — |
| Tranexamic Acid 100 mg/mL 72485-0510-10 | Armas | 10 vials | $0.404 | AP | Availability likely | — |
| Tranexamic Acid 100 mg/mL 72603-0387-10 | Northstar | 10 vials | $0.404 | AP | Availability likely | — |
| tranexamic acid 100 mg/mL 81284-0611-10 | Provepharm | 10 vials | $0.404 | AP | Availability likely | — |
| tranexamic acid 100 mg/mL 81284-0612-10 | Provepharm | 10 vials | $0.404 | AP | Availability likely | — |
| tranexamic acid 100 mg/mL 83634-0401-10 | Avenacy, | 10 vials | $0.404 | 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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
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.
- FDA Orange Book · refreshed Oct 3, 2026
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.
🧪 Avoiding an ingredient? See Tranexamic Acid inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 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.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
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.
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
More NDCs from Emcure Pharmaceuticals Limited labeler code 14593
- Acetazolamide 15 kg/15kg Powder NDC 14593-801-01
- Atazanavir Sulfate 50 kg/50kg Powder NDC 14593-806-01
- sevelamer carbonate 5 kg/5kg Powder NDC 14593-816-01
- Carmustine 130 g/130g Powder NDC 14593-823-01
- Protriptyline HCl 15 kg/15kg Powder NDC 14593-825-01
- Gemcitabine HCl 5 kg/5kg Powder NDC 14593-827-01
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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
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 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.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 14593-318-01 Tranexamic Acid Injection, USP 1000 mg/10 mL (100 mg/mL) Intravenous Use Only Rx only 10 mL Single-Dose Vial label
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.
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 Tranexamic acid — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 42%
Female · 58%
Unknown · 0%
Serious outcomes
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.
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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.
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.