Home NDC 50419-252 Adempas
Product NDC 50419-252
11-digit product format 504190252
Labeler code 50419
Product ID 50419-252_d66cd275-ec90-4215-a5dc-ab622625fbd7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name riociguat
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bayer HealthCare Pharmaceuticals Inc.
Application NDA204819
Marketing category NDA
Marketing start 2013-10-08
Substance RIOCIGUAT
Active strength 1.5 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 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 N204819-001 ADEMPAS RIOCIGUAT 0.5MG TABLET / ORAL AB RLD 2013-10-08 N204819-002 ADEMPAS RIOCIGUAT 1MG TABLET / ORAL AB RLD 2013-10-08 N204819-003 ADEMPAS RIOCIGUAT 1.5MG TABLET / ORAL AB RLD 2013-10-08 N204819-004 ADEMPAS RIOCIGUAT 2MG TABLET / ORAL AB RLD 2013-10-08 N204819-005 ADEMPAS RIOCIGUAT 2.5MG TABLET / ORAL AB RLD, RS 2013-10-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 35 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N204819-001 7173037 2026-12-04 Drug substance, Drug product 2013-11-06 N204819-001 10662188 2034-02-18 U-2834 Drug substance, Drug product 2020-06-23 N204819-001 10662188 2034-02-18 U-2835 Drug substance, Drug product 2020-06-23 N204819-001 11203593 2034-02-18 U-2834 Drug substance, Drug product 2022-01-14 N204819-001 11203593 2034-02-18 U-2835 Drug substance, Drug product 2022-01-14 N204819-001 12503469 2034-02-18 U-2834 Drug product 2026-01-21 N204819-001 12503469 2034-02-18 U-2835 Drug product 2026-01-21 N204819-002 7173037 2026-12-04 Drug substance, Drug product 2013-11-06 N204819-002 10662188 2034-02-18 U-2834 Drug substance, Drug product 2020-06-23 N204819-002 10662188 2034-02-18 U-2835 Drug substance, Drug product 2020-06-23 N204819-002 11203593 2034-02-18 U-2834 Drug substance, Drug product 2022-01-14 N204819-002 11203593 2034-02-18 U-2835 Drug substance, Drug product 2022-01-14 N204819-002 12503469 2034-02-18 U-2834 Drug product 2026-01-21 N204819-002 12503469 2034-02-18 U-2835 Drug product 2026-01-21 N204819-003 7173037 2026-12-04 Drug substance, Drug product 2013-11-06 N204819-003 10662188 2034-02-18 U-2834 Drug substance, Drug product 2020-06-23 N204819-003 10662188 2034-02-18 U-2835 Drug substance, Drug product 2020-06-23 N204819-003 11203593 2034-02-18 U-2834 Drug substance, Drug product 2022-01-14 N204819-003 11203593 2034-02-18 U-2835 Drug substance, Drug product 2022-01-14 N204819-003 12503469 2034-02-18 U-2834 Drug product 2026-01-21 N204819-003 12503469 2034-02-18 U-2835 Drug product 2026-01-21 N204819-004 7173037 2026-12-04 Drug substance, Drug product 2013-11-06 N204819-004 10662188 2034-02-18 U-2834 Drug substance, Drug product 2020-06-23 N204819-004 10662188 2034-02-18 U-2835 Drug substance, Drug product 2020-06-23 N204819-004 11203593 2034-02-18 U-2834 Drug substance, Drug product 2022-01-14 N204819-004 11203593 2034-02-18 U-2835 Drug substance, Drug product 2022-01-14 N204819-004 12503469 2034-02-18 U-2834 Drug product 2026-01-21 N204819-004 12503469 2034-02-18 U-2835 Drug product 2026-01-21 N204819-005 7173037 2026-12-04 Drug substance, Drug product 2013-11-06 N204819-005 10662188 2034-02-18 U-2834 Drug substance, Drug product 2020-06-23 N204819-005 10662188 2034-02-18 U-2835 Drug substance, Drug product 2020-06-23 N204819-005 11203593 2034-02-18 U-2834 Drug substance, Drug product 2022-01-14 N204819-005 11203593 2034-02-18 U-2835 Drug substance, Drug product 2022-01-14 N204819-005 12503469 2034-02-18 U-2834 Drug product 2026-01-21 N204819-005 12503469 2034-02-18 U-2835 Drug product 2026-01-21
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 6 · 205 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 N204819-001 ADEMPAS 0.5MG TABLET / ORAL AB RLD 2013-10-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204819-002 ADEMPAS 1MG TABLET / ORAL AB RLD 2013-10-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204819-003 ADEMPAS 1.5MG TABLET / ORAL AB RLD 2013-10-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204819-004 ADEMPAS 2MG TABLET / ORAL AB RLD 2013-10-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204819-005 ADEMPAS 2.5MG TABLET / ORAL AB RLD, RS 2013-10-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204819-001 ADEMPAS 0.5MG TABLET / ORAL AB RLD 2013-10-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204819-002 ADEMPAS 1MG TABLET / ORAL AB RLD 2013-10-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204819-003 ADEMPAS 1.5MG TABLET / ORAL AB RLD 2013-10-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204819-004 ADEMPAS 2MG TABLET / ORAL AB RLD 2013-10-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204819-005 ADEMPAS 2.5MG TABLET / ORAL AB RLD, RS 2013-10-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204819-001 ADEMPAS 0.5MG TABLET / ORAL AB RLD 2013-10-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204819-002 ADEMPAS 1MG TABLET / ORAL AB RLD 2013-10-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204819-003 ADEMPAS 1.5MG TABLET / ORAL AB RLD 2013-10-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204819-004 ADEMPAS 2MG TABLET / ORAL AB RLD 2013-10-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204819-005 ADEMPAS 2.5MG TABLET / ORAL AB RLD, RS 2013-10-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204819-001 ADEMPAS 0.5MG TABLET / ORAL AB RLD 2013-10-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204819-002 ADEMPAS 1MG TABLET / ORAL AB RLD 2013-10-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204819-003 ADEMPAS 1.5MG TABLET / ORAL AB RLD 2013-10-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204819-004 ADEMPAS 2MG TABLET / ORAL AB RLD 2013-10-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204819-005 ADEMPAS 2.5MG TABLET / ORAL AB RLD, RS 2013-10-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204819-001 ADEMPAS 0.5MG TABLET / ORAL AB RLD 2013-10-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204819-002 ADEMPAS 1MG TABLET / ORAL AB RLD 2013-10-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204819-003 ADEMPAS 1.5MG TABLET / ORAL AB RLD 2013-10-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204819-004 ADEMPAS 2MG TABLET / ORAL AB RLD 2013-10-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204819-005 ADEMPAS 2.5MG TABLET / ORAL AB RLD, RS 2013-10-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204819-001 ADEMPAS 0.5MG TABLET / ORAL AB RLD 2013-10-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204819-002 ADEMPAS 1MG TABLET / ORAL AB RLD 2013-10-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204819-003 ADEMPAS 1.5MG TABLET / ORAL AB RLD 2013-10-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204819-004 ADEMPAS 2MG TABLET / ORAL AB RLD 2013-10-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204819-005 ADEMPAS 2.5MG TABLET / ORAL AB RLD, RS 2013-10-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204819-001 ADEMPAS 0.5MG TABLET / ORAL AB RLD 2013-10-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204819-002 ADEMPAS 1MG TABLET / ORAL AB RLD 2013-10-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204819-003 ADEMPAS 1.5MG TABLET / ORAL AB RLD 2013-10-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204819-004 ADEMPAS 2MG TABLET / ORAL AB RLD 2013-10-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204819-005 ADEMPAS 2.5MG TABLET / ORAL AB RLD, RS 2013-10-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204819-001 ADEMPAS 0.5MG TABLET / ORAL AB RLD 2013-10-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204819-002 ADEMPAS 1MG TABLET / ORAL AB RLD 2013-10-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204819-003 ADEMPAS 1.5MG TABLET / ORAL AB RLD 2013-10-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204819-004 ADEMPAS 2MG TABLET / ORAL AB RLD 2013-10-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204819-005 ADEMPAS 2.5MG TABLET / ORAL AB RLD, RS 2013-10-08 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 135 observed states.
Observed Orange Book patent history# Patent history page 1 of 24 · 935 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N204819-001 7173037 2026-12-04 Drug substance, Drug product 2013-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204819-001 10662188 2034-02-18 U-2834 Drug substance, Drug product 2020-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204819-001 10662188 2034-02-18 U-2835 Drug substance, Drug product 2020-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204819-001 11203593 2034-02-18 U-2834 Drug substance, Drug product 2022-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204819-001 11203593 2034-02-18 U-2835 Drug substance, Drug product 2022-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204819-001 12503469 2034-02-18 U-2834 Drug product 2026-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204819-001 12503469 2034-02-18 U-2835 Drug product 2026-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204819-002 7173037 2026-12-04 Drug substance, Drug product 2013-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204819-002 10662188 2034-02-18 U-2834 Drug substance, Drug product 2020-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204819-002 10662188 2034-02-18 U-2835 Drug substance, Drug product 2020-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204819-002 11203593 2034-02-18 U-2834 Drug substance, Drug product 2022-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204819-002 11203593 2034-02-18 U-2835 Drug substance, Drug product 2022-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204819-002 12503469 2034-02-18 U-2834 Drug product 2026-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204819-002 12503469 2034-02-18 U-2835 Drug product 2026-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204819-003 7173037 2026-12-04 Drug substance, Drug product 2013-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204819-003 10662188 2034-02-18 U-2834 Drug substance, Drug product 2020-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204819-003 10662188 2034-02-18 U-2835 Drug substance, Drug product 2020-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204819-003 11203593 2034-02-18 U-2834 Drug substance, Drug product 2022-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204819-003 11203593 2034-02-18 U-2835 Drug substance, Drug product 2022-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204819-003 12503469 2034-02-18 U-2834 Drug product 2026-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204819-003 12503469 2034-02-18 U-2835 Drug product 2026-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204819-004 7173037 2026-12-04 Drug substance, Drug product 2013-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204819-004 10662188 2034-02-18 U-2834 Drug substance, Drug product 2020-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204819-004 10662188 2034-02-18 U-2835 Drug substance, Drug product 2020-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204819-004 11203593 2034-02-18 U-2834 Drug substance, Drug product 2022-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204819-004 11203593 2034-02-18 U-2835 Drug substance, Drug product 2022-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204819-004 12503469 2034-02-18 U-2834 Drug product 2026-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204819-004 12503469 2034-02-18 U-2835 Drug product 2026-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204819-005 7173037 2026-12-04 Drug substance, Drug product 2013-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204819-005 10662188 2034-02-18 U-2835 Drug substance, Drug product 2020-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204819-005 10662188 2034-02-18 U-2834 Drug substance, Drug product 2020-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204819-005 11203593 2034-02-18 U-2834 Drug substance, Drug product 2022-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204819-005 11203593 2034-02-18 U-2835 Drug substance, Drug product 2022-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204819-005 12503469 2034-02-18 U-2834 Drug product 2026-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204819-005 12503469 2034-02-18 U-2835 Drug product 2026-01-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204819-001 7173037 2026-12-04 Drug substance, Drug product 2013-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204819-001 10662188 2034-02-18 U-2834 Drug substance, Drug product 2020-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204819-001 10662188 2034-02-18 U-2835 Drug substance, Drug product 2020-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204819-001 11203593 2034-02-18 U-2834 Drug substance, Drug product 2022-01-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204819-001 11203593 2034-02-18 U-2835 Drug substance, Drug product 2022-01-14 31067a03dcf5…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Adempas
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RIOCIGUAT 1.5 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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 10 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1439821 Internal RxNorm lookup 1439823 Internal RxNorm lookup 1439831 Internal RxNorm lookup 1439833 Internal RxNorm lookup 1439837 Internal RxNorm lookup 1439894 Internal RxNorm lookup 1439896 Internal RxNorm lookup 1439899 Internal RxNorm lookup 1439901 Internal RxNorm lookup 1439903 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50419-252-01 Adempas 90 in 1 BOTTLE TABLET, FILM COATED 90 29 50419-252-03 Adempas 21 in 1 BLISTER PACK TABLET, FILM COATED 21 29 50419-252-03 Adempas 2 in 1 PACKAGE TABLET, FILM COATED 2 29 50419-252-91 Adempas 9 in 1 BOTTLE TABLET, FILM COATED 9 29
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded RIOCIGUAT ACTIVE INGREDIENT RU3FE2Y4XI ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 8 RIOCIGUAT ACTIVE MOIETY RU3FE2Y4XI ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 8 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 8 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 8 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 8 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 8 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 8 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 8 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 8 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 8 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 8 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50419-252 ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 20 Current NDC, Legacy NDC, 4 package rows 20241106_7b57509a-3d5d-41d4-8fed-1471e26372a3.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Adempas RIOCIGUAT Bayer HealthCare Pharmaceuticals Inc. 7b57509a-3d5d-41d4-8fed-1471e26372a3 2026-06-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 204819 application number: NDA204819 ndc (product): 50419-252
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50419-252-01 50419025201 90 TABLET, FILM COATED in 1 BOTTLE (50419-252-01) 2013-12-08 0000-00-00 No No Current 50419-252-03 50419025203 2 BLISTER PACK in 1 PACKAGE (50419-252-03) / 21 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2013-10-08 0000-00-00 No No Current 50419-252-91 50419025291 9 TABLET, FILM COATED in 1 BOTTLE (50419-252-91) 2014-09-18 0000-00-00 No No Current