Home NDC 70710-2159-9 Riociguat
Product NDC 70710-2159
Requested package NDC 70710-2159-9
11-digit product format 707102159
Labeler code 70710
Product ID 70710-2159_b7d9755e-0ea7-405a-90b5-95ae93e9c3b3
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 2026-09-18
Substance RIOCIGUAT
Active strength 2 mg/1
Pharmacologic classes Guanylate Cyclase Stimulators [MoA], Soluble Guanylate Cyclase Stimulator [EPC]
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 · 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 · 145 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 2026-09-14 22:38:34 2026-08 A211135-001 RIOCIGUAT 0.5MG TABLET / ORAL AB 2022-09-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211135-002 RIOCIGUAT 1MG TABLET / ORAL AB 2022-09-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211135-003 RIOCIGUAT 1.5MG TABLET / ORAL AB 2022-09-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211135-004 RIOCIGUAT 2MG TABLET / ORAL AB 2022-09-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211135-005 RIOCIGUAT 2.5MG TABLET / ORAL AB 2022-09-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211135-001 RIOCIGUAT 0.5MG TABLET / ORAL AB 2022-09-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211135-002 RIOCIGUAT 1MG TABLET / ORAL AB 2022-09-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211135-003 RIOCIGUAT 1.5MG TABLET / ORAL AB 2022-09-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211135-004 RIOCIGUAT 2MG TABLET / ORAL AB 2022-09-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211135-005 RIOCIGUAT 2.5MG TABLET / ORAL AB 2022-09-01 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 4 of 4 · 145 observed states.
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 Riociguat
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RIOCIGUAT 2 mg/1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 70710-2159-9 70710215909 90 TABLET, FILM COATED in 1 BOTTLE (70710-2159-9) 2026-09-18 No No Current