What is NDC 33342-488?

33342-488 is the product NDC for Rivaroxaban, Rivaroxaban 2.5 mg/1 tablet, film coated, listed with the FDA by Macleods Pharmaceuticals Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.

Macleods Pharmaceuticals Limited, NDC labeler code 33342. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Rivaroxaban?

32 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Rivaroxaban NDC 33342-488 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-488Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0488Add 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
33342-488-09	3334204880933342048809	60 TABLET, FILM COATED in 1 BOTTLE (33342-488-09)Marketed from May 14, 2025
33342-488-57	3334204885733342048857	180 TABLET, FILM COATED in 1 BOTTLE (33342-488-57)Marketed from May 14, 2025
33342-488-98	3334204889833342048898	10 BLISTER PACK in 1 CARTON (33342-488-98) / 6 TABLET, FILM COATED in 1 BLISTER PACKMarketed from May 14, 2025

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): Rivaroxaban
Generic name (nonproprietary): rivaroxaban
Active ingredients: Rivaroxaban — 2.5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Macleods Pharmaceuticals LimitedNDC labeler code 33342
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213114
Marketing start: May 14, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Factor Xa Inhibitors (Mechanism)
Identifiers: Product ID 33342-488_b6691115-e5df-4846-8358-79d091cdc3c0SPL ID b6691115-e5df-4846-8358-79d091cdc3c0SPL set ID 57717a31-d9d3-4246-90c0-4e4c0a29adf5RxCUI 2059015UNII 9NDF7JZ4M3UPC 0333342488572
Pharmacologic class: Factor Xa Inhibitor

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

N433342048809 followed by a unit qualifier and the quantity

Package 33342-0488-09. 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 Apr 6, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Rivaroxaban tablets are a factor Xa inhibitor indicated: • to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) ( 1.7 ) • to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD ( 1.8 ) 1.7 Reduction of Risk of Major Cardiovascular Events in Patients with Coronary Artery Disease (CAD) Rivaroxaban tablets, in combination with aspirin, is indicated to reduce the risk of major cardiovascular events (cardiovascular death, myocardial infarction, and stroke) in adult patients with coronary artery disease. 1.8 Reduction…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 33342-488

What is NDC 33342-488?: 33342-488 is the product NDC for Rivaroxaban, Rivaroxaban 2.5 mg/1 tablet, film coated, listed with the FDA by Macleods Pharmaceuticals Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Rivaroxaban.
What is the active ingredient?: Rivaroxaban.
Who is the labeler?: Macleods Pharmaceuticals Limited, NDC labeler code 33342. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Rivaroxaban?: 32 other product NDCs are listed under this name. See all Rivaroxaban 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 Rivaroxaban NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Rivaroxaban	Rivaroxaban 2.5 mg/1	TabletOral	Lifestar Pharma LLC	70756-006	70756-0006-1270756-0006-6070756-0006-81+1 more
Rivaroxaban	Rivaroxaban 2.5 mg/1	TabletOral	Micro Labs Limited	42571-345	42571-0345-0542571-0345-3042571-0345-60
Rivaroxaban	Rivaroxaban 2.5 mg/1	Tablet, Film coatedOral	NorthStar RxLLC	72603-890	72603-0890-0172603-0890-02
rivaroxaban	Rivaroxaban 10 mg/1	Tablet, Film coatedOral	Changzhou Pharmaceutical Factory	55488-0540	55488-0540-01
rivaroxaban	Rivaroxaban 15 mg/1	Tablet, Film coatedOral	Changzhou Pharmaceutical Factory	55488-0541	55488-0541-01
rivaroxaban	Rivaroxaban 20 mg/1	Tablet, Film coatedOral	Changzhou Pharmaceutical Factory	55488-0542	55488-0542-01
Rivaroxaban	Rivaroxaban 2.5 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals, Inc.	72865-321	72865-0321-1872865-0321-60
Rivaroxaban	Rivaroxaban 2.5 mg/1	Tablet, Film coatedOral	Novadoz Pharmaceuticals LLC	72205-416	72205-0416-0272205-0416-0372205-0416-04+1 more
Rivaroxaban	Rivaroxaban 2.5 mg/1	Tablet, CoatedOral	Sun Pharmaceutical Industries, Inc.	51672-4228	51672-4228-0451672-4228-09
rivaroxaban	Rivaroxaban 2.5 mg/1	TabletOral	Florida Pharmaceutical Products, LLC	71921-405	71921-0405-0671921-0405-21

All 33 Rivaroxaban NDCs

Other NDCs under ANDA 213114

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

FDA NDC Directory listings under ANDA 213114
Product	Strength	Form · route	Labeler	Product NDC
Rivaroxaban	Rivaroxaban 2.5 mg/1	Tablet, Film coatedOral	NorthStar RxLLC	72603-890