Home NDC 70710-1551 Selexipag
Product NDC 70710-1551
11-digit product format 707101551
Labeler code 70710
Product ID 70710-1551_76164432-4f15-47f2-a3d5-1e46652dc992
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Selexipag
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zydus Pharmaceuticals (USA) Inc.
Application ANDA214302
Marketing category ANDA
Marketing start 2025-02-14
Substance SELEXIPAG
Active strength 200 ug/1
Pharmacologic classes Prostacyclin Receptor Agonist [EPC], Prostacyclin Receptor Agonists [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 · 8 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214302-001 SELEXIPAG SELEXIPAG 0.2MG TABLET / ORAL 2022-12-21 A214302-002 SELEXIPAG SELEXIPAG 0.4MG TABLET / ORAL 2022-12-21 A214302-003 SELEXIPAG SELEXIPAG 0.6MG TABLET / ORAL 2022-12-21 A214302-004 SELEXIPAG SELEXIPAG 0.8MG TABLET / ORAL 2022-12-21 A214302-005 SELEXIPAG SELEXIPAG 1MG TABLET / ORAL 2022-12-21 A214302-006 SELEXIPAG SELEXIPAG 1.2MG TABLET / ORAL 2022-12-21 A214302-007 SELEXIPAG SELEXIPAG 1.4MG TABLET / ORAL 2022-12-21 A214302-008 SELEXIPAG SELEXIPAG 1.6MG TABLET / ORAL 2022-12-21
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 · 208 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 A214302-001 SELEXIPAG 0.2MG TABLET / ORAL 2022-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214302-002 SELEXIPAG 0.4MG TABLET / ORAL 2022-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214302-003 SELEXIPAG 0.6MG TABLET / ORAL 2022-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214302-004 SELEXIPAG 0.8MG TABLET / ORAL 2022-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214302-005 SELEXIPAG 1MG TABLET / ORAL 2022-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214302-006 SELEXIPAG 1.2MG TABLET / ORAL 2022-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214302-007 SELEXIPAG 1.4MG TABLET / ORAL 2022-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214302-008 SELEXIPAG 1.6MG TABLET / ORAL 2022-12-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214302-001 SELEXIPAG 0.2MG TABLET / ORAL 2022-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214302-002 SELEXIPAG 0.4MG TABLET / ORAL 2022-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214302-003 SELEXIPAG 0.6MG TABLET / ORAL 2022-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214302-004 SELEXIPAG 0.8MG TABLET / ORAL 2022-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214302-005 SELEXIPAG 1MG TABLET / ORAL 2022-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214302-006 SELEXIPAG 1.2MG TABLET / ORAL 2022-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214302-007 SELEXIPAG 1.4MG TABLET / ORAL 2022-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214302-008 SELEXIPAG 1.6MG TABLET / ORAL 2022-12-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214302-001 SELEXIPAG 0.2MG TABLET / ORAL 2022-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214302-002 SELEXIPAG 0.4MG TABLET / ORAL 2022-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214302-003 SELEXIPAG 0.6MG TABLET / ORAL 2022-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214302-004 SELEXIPAG 0.8MG TABLET / ORAL 2022-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214302-005 SELEXIPAG 1MG TABLET / ORAL 2022-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214302-006 SELEXIPAG 1.2MG TABLET / ORAL 2022-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214302-007 SELEXIPAG 1.4MG TABLET / ORAL 2022-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214302-008 SELEXIPAG 1.6MG TABLET / ORAL 2022-12-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214302-001 SELEXIPAG 0.2MG TABLET / ORAL 2022-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214302-002 SELEXIPAG 0.4MG TABLET / ORAL 2022-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214302-003 SELEXIPAG 0.6MG TABLET / ORAL 2022-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214302-004 SELEXIPAG 0.8MG TABLET / ORAL 2022-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214302-005 SELEXIPAG 1MG TABLET / ORAL 2022-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214302-006 SELEXIPAG 1.2MG TABLET / ORAL 2022-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214302-007 SELEXIPAG 1.4MG TABLET / ORAL 2022-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214302-008 SELEXIPAG 1.6MG TABLET / ORAL 2022-12-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214302-001 SELEXIPAG 0.2MG TABLET / ORAL 2022-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214302-002 SELEXIPAG 0.4MG TABLET / ORAL 2022-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214302-003 SELEXIPAG 0.6MG TABLET / ORAL 2022-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214302-004 SELEXIPAG 0.8MG TABLET / ORAL 2022-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214302-005 SELEXIPAG 1MG TABLET / ORAL 2022-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214302-006 SELEXIPAG 1.2MG TABLET / ORAL 2022-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214302-007 SELEXIPAG 1.4MG TABLET / ORAL 2022-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214302-008 SELEXIPAG 1.6MG TABLET / ORAL 2022-12-21 6a471c1ec25d…
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 Selexipag
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SELEXIPAG 200 ug/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70710-1551-6 Selexipag 60 in 1 BOTTLE TABLET, FILM COATED 60 3 70710-1551-8 Selexipag 140 in 1 BOTTLE TABLET, FILM COATED 140 3 70710-1551-8 Selexipag TITRATION PACK 140 in 1 BOTTLE TABLET, FILM COATED 140 200 ug 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70710-1551 SELEXIPAG TABLET, FILM COATED SELEXIPAG TITRATION PACK (SELEXIPAG) KIT [ZYDUS PHARMACEUTICALS (USA) INC.] 3 Current NDC, 2 package rows 20250215_c604e181-e336-4194-bf96-f65dd164d461.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 70710-1551-6 70710155106 60 TABLET, FILM COATED in 1 BOTTLE (70710-1551-6) 2025-02-14 Yes No Current 70710-1551-8 70710155108 140 TABLET, FILM COATED in 1 BOTTLE (70710-1551-8) 2025-02-14 Yes No Current