Home NDC 70710-2159 Riociguat
Product NDC 70710-2159
11-digit product format 707102159
Labeler code 70710
Product ID 70710-2159_8092c64b-e240-43c3-9d2e-e0dd7708d96f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Riociguat
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc
Application ANDA211135
Marketing category ANDA
Marketing start 2022-09-01
Substance RIOCIGUAT
Active strength 2 mg/1
Pharmacologic classes Guanylate Cyclase Stimulators [MoA]; Soluble Guanylate Cyclase Stimulator [EPC]
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211135-001 RIOCIGUAT RIOCIGUAT 0.5MG TABLET / ORAL AB 2022-09-01 A211135-002 RIOCIGUAT RIOCIGUAT 1MG TABLET / ORAL AB 2022-09-01 A211135-003 RIOCIGUAT RIOCIGUAT 1.5MG TABLET / ORAL AB 2022-09-01 A211135-004 RIOCIGUAT RIOCIGUAT 2MG TABLET / ORAL AB 2022-09-01 A211135-005 RIOCIGUAT RIOCIGUAT 2.5MG TABLET / ORAL AB 2022-09-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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.
Product history page 1 of 4 · 135 observed 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 2026-02-19 14:30 UTC 2026-02 A211135-001 RIOCIGUAT 0.5MG TABLET / ORAL AB 2022-09-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211135-002 RIOCIGUAT 1MG TABLET / ORAL AB 2022-09-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211135-003 RIOCIGUAT 1.5MG TABLET / ORAL AB 2022-09-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211135-004 RIOCIGUAT 2MG TABLET / ORAL AB 2022-09-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211135-005 RIOCIGUAT 2.5MG TABLET / ORAL AB 2022-09-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211135-001 RIOCIGUAT 0.5MG TABLET / ORAL AB 2022-09-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211135-002 RIOCIGUAT 1MG TABLET / ORAL AB 2022-09-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211135-003 RIOCIGUAT 1.5MG TABLET / ORAL AB 2022-09-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211135-004 RIOCIGUAT 2MG TABLET / ORAL AB 2022-09-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211135-005 RIOCIGUAT 2.5MG TABLET / ORAL AB 2022-09-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211135-001 RIOCIGUAT 0.5MG TABLET / ORAL AB 2022-09-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211135-002 RIOCIGUAT 1MG TABLET / ORAL AB 2022-09-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211135-003 RIOCIGUAT 1.5MG TABLET / ORAL AB 2022-09-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211135-004 RIOCIGUAT 2MG TABLET / ORAL AB 2022-09-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211135-005 RIOCIGUAT 2.5MG TABLET / ORAL AB 2022-09-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211135-001 RIOCIGUAT 0.5MG TABLET / ORAL AB 2022-09-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211135-002 RIOCIGUAT 1MG TABLET / ORAL AB 2022-09-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211135-003 RIOCIGUAT 1.5MG TABLET / ORAL AB 2022-09-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211135-004 RIOCIGUAT 2MG TABLET / ORAL AB 2022-09-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211135-005 RIOCIGUAT 2.5MG TABLET / ORAL AB 2022-09-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211135-001 RIOCIGUAT 0.5MG TABLET / ORAL AB 2022-09-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211135-002 RIOCIGUAT 1MG TABLET / ORAL AB 2022-09-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211135-003 RIOCIGUAT 1.5MG TABLET / ORAL AB 2022-09-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211135-004 RIOCIGUAT 2MG TABLET / ORAL AB 2022-09-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211135-005 RIOCIGUAT 2.5MG TABLET / ORAL AB 2022-09-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211135-001 RIOCIGUAT 0.5MG TABLET / ORAL AB 2022-09-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211135-002 RIOCIGUAT 1MG TABLET / ORAL AB 2022-09-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211135-003 RIOCIGUAT 1.5MG TABLET / ORAL AB 2022-09-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211135-004 RIOCIGUAT 2MG TABLET / ORAL AB 2022-09-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211135-005 RIOCIGUAT 2.5MG TABLET / ORAL AB 2022-09-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211135-001 RIOCIGUAT 0.5MG TABLET / ORAL AB 2022-09-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211135-002 RIOCIGUAT 1MG TABLET / ORAL AB 2022-09-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211135-003 RIOCIGUAT 1.5MG TABLET / ORAL AB 2022-09-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211135-004 RIOCIGUAT 2MG TABLET / ORAL AB 2022-09-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211135-005 RIOCIGUAT 2.5MG TABLET / ORAL AB 2022-09-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211135-001 RIOCIGUAT 0.5MG TABLET / ORAL AB 2022-09-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211135-002 RIOCIGUAT 1MG TABLET / ORAL AB 2022-09-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211135-003 RIOCIGUAT 1.5MG TABLET / ORAL AB 2022-09-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211135-004 RIOCIGUAT 2MG TABLET / ORAL AB 2022-09-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211135-005 RIOCIGUAT 2.5MG TABLET / ORAL AB 2022-09-01 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 135 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Riociguat
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RIOCIGUAT 2 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination RU3FE2Y4XI Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.