NDC codes

FDA NDC Directory
Product NDC (as listed)59651-839Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59651-0839Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
59651-839-30596510839305965108393030 TABLET in 1 BOTTLE (59651-839-30)Marketed from Dec 4, 2023

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Tranexamic Acid
Generic name (nonproprietary)
tranexamic acid
Active ingredients
Tranexamic acid — 650 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Aurobindo Pharma LimitedNDC labeler code 59651
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205133
Marketing start
Listing expires
Other FDA classes
Decreased Fibrinolysis (Physiologic effect)
Identifiers
Product ID 59651-839_773eb919-7d48-4ba2-af58-aa169f0ea75fSPL ID 773eb919-7d48-4ba2-af58-aa169f0ea75fSPL set ID 773eb919-7d48-4ba2-af58-aa169f0ea75fRxCUI 883826UNII 6T84R30KC1
Pharmacologic class
Antifibrinolytic Agent

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N459651083930 followed by a unit qualifier and the quantity

Package 59651-0839-30. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

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 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 59651-839

What is NDC 59651-839?
59651-839 is the product NDC for Tranexamic Acid, Tranexamic acid 650 mg/1 tablet, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Tranexamic Acid.
What is the active ingredient?
Tranexamic acid.
Who is the labeler?
Aurobindo Pharma Limited, NDC labeler code 59651. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tranexamic Acid?
43 other product NDCs are listed under this name. See all Tranexamic Acid NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Tranexamic Acid NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Tranexamic AcidTranexamic acid 650 mg/1TabletOralNorthStar Rx LLC72603-81872603-0818-01
Tranexamic AcidTranexamic acid 650 mg/1TabletOrali3 Pharmaceuticals, LLC72319-02872319-0028-01
Tranexamic AcidTranexamic acid 650 mg/1TabletOralDr. Reddy's Laboratories Inc.75907-30975907-0309-30
Tranexamic AcidTranexamic acid 100 mg/mLInjectionIntravenousCaplin Steriles Limited65145-10665145-0106-10
Tranexamic AcidTranexamic acid 100 mg/mLInjectionIntravenousHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-90923155-0909-41
Tranexamic AcidTranexamic acid 100 mg/mLInjectionIntravenousHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-91023155-0910-41
Tranexamic AcidTranexamic acid 100 mg/mLInjectionIntravenousNorthstar Rx LLC72603-38772603-0387-10
Tranexamic AcidTranexamic acid 1 g/10mLInjection, SolutionIntravenousEmcure Pharmaceuticals Limited14593-31814593-0318-01
Tranexamic AcidTranexamic acid 10 mg/mLInjection, SolutionIntravenousSagent Pharmaceuticals25021-41825021-0418-82
Tranexamic AcidTranexamic acid 10 mg/mLInjection, SolutionIntravenousNexus Pharmaceuticals LLC14789-11514789-0115-05

All 44 Tranexamic Acid NDCs

Other NDCs under ANDA 205133

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 205133
ProductStrengthForm · routeLabelerProduct NDC
Tranexamic AcidTranexamic acid 650 mg/1TabletOralNorthStar Rx LLC72603-818

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