What is NDC 82804-208?

82804-208 is the product NDC for Tranexamic Acid, Tranexamic acid 650 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 1 package NDC, shown above in 10- and 11-digit form.

Proficient Rx LP, NDC labeler code 82804. 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 82804-208 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)82804-208Labeler and product segments. Claims need a package NDC.

Product NDC at billing width82804-0208Add 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	Copy
82804-208-15	8280402081582804020815	15 TABLET in 1 BOTTLE (82804-208-15)Marketed from Jun 11, 2024

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: Proficient Rx LPNDC labeler code 82804
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218320
Marketing start: Jun 11, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Fibrinolysis (Physiologic effect)
Identifiers: Product ID 82804-208_416cdb61-31fb-4554-835f-a7744aa33b61SPL ID 416cdb61-31fb-4554-835f-a7744aa33b61SPL set ID 416cdb61-31fb-4554-835f-a7744aa33b61RxCUI 883826UNII 6T84R30KC1UPC 0382804208159
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

N482804020815 followed by a unit qualifier and the quantity

Package 82804-0208-15. 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 Mar 1, 2025.

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 82804-208

What is NDC 82804-208?: 82804-208 is the product NDC for Tranexamic Acid, Tranexamic acid 650 mg/1 tablet, listed with the FDA by Proficient Rx LP. 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?: Proficient Rx LP, NDC labeler code 82804. 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 218320

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

FDA NDC Directory listings under ANDA 218320
Product	Strength	Form · route	Labeler	Product NDC
Tranexamic Acid	Tranexamic acid 650 mg/1	TabletOral	Bryant Ranch Prepack	71335-2695
Tranexamic Acid	Tranexamic acid 650 mg/1	TabletOral	ADVAGEN PHARMA LIMITED	72888-178