What is NDC 46708-346?

46708-346 is the product NDC for Rivaroxaban, Rivaroxaban 10 mg/1 tablet, film coated, listed with the FDA by Alembic Pharmaceuticals Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.

Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 46708-346 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-346Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0346Add 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
46708-346-10	4670803461046708034610	100 BLISTER PACK in 1 CARTON (46708-346-10) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from May 14, 2025
46708-346-30	4670803463046708034630	30 TABLET, FILM COATED in 1 BOTTLE (46708-346-30)Marketed from May 14, 2025
46708-346-90	4670803469046708034690	90 TABLET, FILM COATED in 1 BOTTLE (46708-346-90)Marketed from May 14, 2025
46708-346-91	4670803469146708034691	1000 TABLET, FILM COATED in 1 BOTTLE (46708-346-91)Marketed 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 — 10 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Alembic Pharmaceuticals LimitedNDC labeler code 46708
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210301
Marketing start: May 14, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Factor Xa Inhibitors (Mechanism)
Identifiers: Product ID 46708-346_4b61dc52-0593-4ef0-8246-a82ff6972842SPL ID 4b61dc52-0593-4ef0-8246-a82ff6972842SPL set ID 5524f30f-789d-4f5c-8f7c-d03a475b6d34RxCUI 1114198, 1232082, 1232086, 1549682, 2059015UNII 9NDF7JZ4M3
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

N446708034610 followed by a unit qualifier and the quantity

Package 46708-0346-10. 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 Nov 21, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Rivaroxaban tablet is a factor Xa inhibitor indicated: • to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation ( 1.1 ) • for treatment of deep vein thrombosis (DVT) ( 1.2 ) • for treatment of pulmonary embolism (PE) ( 1.3 ) • for reduction in the risk of recurrence of DVT or PE ( 1.4 ) • for prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery ( 1.5 ) • for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients ( 1.6 ) • 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 peri…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 46708-346

What is NDC 46708-346?: 46708-346 is the product NDC for Rivaroxaban, Rivaroxaban 10 mg/1 tablet, film coated, listed with the FDA by Alembic Pharmaceuticals Limited. It has 4 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?: Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 210301

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

FDA NDC Directory listings under ANDA 210301
Product	Strength	Form · route	Labeler	Product NDC
Rivaroxaban	Rivaroxaban 10 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-346
Rivaroxaban	Rivaroxaban 15 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-347
Rivaroxaban	Rivaroxaban 20 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-348
Rivaroxaban	—	Kit	Alembic Pharmaceuticals Limited	46708-240
Rivaroxaban	Rivaroxaban 2.5 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-683
Rivaroxaban	Rivaroxaban 15 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-347
Rivaroxaban	Rivaroxaban 20 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-348
Rivaroxaban	Rivaroxaban 2.5 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-683
Rivaroxaban	—	Kit	Alembic Pharmaceuticals Inc.	62332-240