What is NDC 71335-1981?

71335-1981 is the product NDC for Tranexamic Acid, Tranexamic acid 650 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 3 package NDCs, shown above in 10- and 11-digit form.

Bryant Ranch Prepack, NDC labeler code 71335. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tranexamic Acid NDC 71335-1981 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-1981Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-1981Add 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 NDC	11-digit (billing)	Package
71335-1981-1	7133519810171335198101	8 TABLET in 1 BOTTLE (71335-1981-1)Marketed from Oct 22, 2021
71335-1981-2	7133519810271335198102	30 TABLET in 1 BOTTLE (71335-1981-2)Marketed from May 31, 2024
71335-1981-3	7133519810371335198103	4 TABLET in 1 BOTTLE (71335-1981-3)Marketed from Sep 27, 2022

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: Bryant Ranch PrepackNDC labeler code 71335
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203256
Marketing start: Jul 1, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Fibrinolysis (Physiologic effect)
Identifiers: Product ID 71335-1981_6f970956-0abd-4d4e-b3e0-3c296a401970SPL ID 6f970956-0abd-4d4e-b3e0-3c296a401970SPL set ID af95be04-a6ea-4789-8e79-7dcad332c640RxCUI 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

N471335198101 followed by a unit qualifier and the quantity

Package 71335-1981-01. 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 Aug 8, 2024.

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 71335-1981

What is NDC 71335-1981?: 71335-1981 is the product NDC for Tranexamic Acid, Tranexamic acid 650 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 3 package NDCs, 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?: Bryant Ranch Prepack, NDC labeler code 71335. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Tranexamic Acid	Tranexamic acid 650 mg/1	TabletOral	NorthStar Rx LLC	72603-818	72603-0818-01
Tranexamic Acid	Tranexamic acid 650 mg/1	TabletOral	i3 Pharmaceuticals, LLC	72319-028	72319-0028-01
Tranexamic Acid	Tranexamic acid 650 mg/1	TabletOral	Dr. Reddy's Laboratories Inc.	75907-309	75907-0309-30
Tranexamic Acid	Tranexamic acid 100 mg/mL	InjectionIntravenous	Caplin Steriles Limited	65145-106	65145-0106-10
Tranexamic Acid	Tranexamic acid 100 mg/mL	InjectionIntravenous	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-909	23155-0909-41
Tranexamic Acid	Tranexamic acid 100 mg/mL	InjectionIntravenous	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-910	23155-0910-41
Tranexamic Acid	Tranexamic acid 100 mg/mL	InjectionIntravenous	Northstar Rx LLC	72603-387	72603-0387-10
Tranexamic Acid	Tranexamic acid 1 g/10mL	Injection, SolutionIntravenous	Emcure Pharmaceuticals Limited	14593-318	14593-0318-01
Tranexamic Acid	Tranexamic acid 10 mg/mL	Injection, SolutionIntravenous	Sagent Pharmaceuticals	25021-418	25021-0418-82
Tranexamic Acid	Tranexamic acid 10 mg/mL	Injection, SolutionIntravenous	Nexus Pharmaceuticals LLC	14789-115	14789-0115-05

All 44 Tranexamic Acid NDCs

Other NDCs under ANDA 203256

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

FDA NDC Directory listings under ANDA 203256
Product	Strength	Form · route	Labeler	Product NDC
Tranexamic Acid	Tranexamic acid 650 mg/1	TabletOral	American Health Packaging	60687-750
Tranexamic Acid	Tranexamic acid 650 mg/1	TabletOral	ANI Pharmaceuticals, Inc.	62559-265