Home NDC 70756-006 RIVAROXABAN
Product NDC 70756-006
11-digit product format 707560006
Labeler code 70756
Product ID 70756-006_0438bd24-fd5f-476b-a7e8-eeab15f3551b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name rivaroxaban
Dosage form TABLET
Route ORAL
Labeler Lifestar Pharma LLC
Application ANDA220874
Marketing category ANDA
Marketing start 2026-10-01
Substance RIVAROXABAN
Active strength 2.5 mg/1
Pharmacologic classes Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A220874-001 RIVAROXABAN RIVAROXABAN 2.5MG TABLET / ORAL AB 2026-07-01 A220874-002 RIVAROXABAN RIVAROXABAN 10MG TABLET / ORAL AB 2026-07-01 A220874-003 RIVAROXABAN RIVAROXABAN 15MG TABLET / ORAL AB 2026-07-01 A220874-004 RIVAROXABAN RIVAROXABAN 20MG TABLET / ORAL AB 2026-07-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A220874-001 RIVAROXABAN 2.5MG TABLET / ORAL AB 2026-07-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A220874-002 RIVAROXABAN 10MG TABLET / ORAL AB 2026-07-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A220874-003 RIVAROXABAN 15MG TABLET / ORAL AB 2026-07-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A220874-004 RIVAROXABAN 20MG TABLET / ORAL AB 2026-07-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 A220874-001 RIVAROXABAN 2.5MG TABLET / ORAL AB 2026-07-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A220874-002 RIVAROXABAN 10MG TABLET / ORAL AB 2026-07-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A220874-003 RIVAROXABAN 15MG TABLET / ORAL AB 2026-07-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A220874-004 RIVAROXABAN 20MG TABLET / ORAL AB 2026-07-01 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220874-001 RIVAROXABAN 2.5MG TABLET / ORAL AB 2026-07-01 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220874-002 RIVAROXABAN 10MG TABLET / ORAL AB 2026-07-01 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220874-003 RIVAROXABAN 15MG TABLET / ORAL AB 2026-07-01 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220874-004 RIVAROXABAN 20MG TABLET / ORAL AB 2026-07-01 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base RIVAROXABAN
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RIVAROXABAN 2.5 mg/1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70756-006-12 70756000612 1000 TABLET in 1 BOTTLE (70756-006-12) 1000 tablet 2026-10-01 No No Current 70756-006-60 70756000660 60 TABLET in 1 BOTTLE (70756-006-60) 60 tablet 2026-10-01 No No Current 70756-006-81 70756000681 180 TABLET in 1 BOTTLE (70756-006-81) 180 tablet 2026-10-01 No No Current 70756-006-99 70756000699 10 BLISTER PACK in 1 CARTON (70756-006-99) / 10 TABLET in 1 BLISTER PACK 10 blister pack 2026-10-01 No No Current