Home NDC 68974-400 FILSPARI
Product NDC 68974-400
11-digit product format 689740400
Labeler code 68974
Product ID 68974-400_2299f93e-22fc-48ac-8d06-c558fc57bb0d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sparsentan
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Travere Therapeutics, Inc.
Application NDA216403
Marketing category NDA
Marketing start 2023-02-17
Substance SPARSENTAN
Active strength 400 mg/1
Pharmacologic classes Angiotensin 2 Receptor Blocker [EPC], Angiotensin 2 Type 1 Receptor Antagonists [MoA], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA], P-Glycoprotein 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N216403-001 FILSPARI SPARSENTAN 200MG TABLET / ORAL RLD 2023-02-17 N216403-002 FILSPARI SPARSENTAN 400MG TABLET / ORAL RLD, RS 2023-02-17
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N216403-001 9662312 2030-03-29 U-4495 2026-05-07 N216403-001 9993461 2030-03-29 U-3269 2023-03-14 N216403-001 9993461 2030-03-29 U-3993 2023-03-14 N216403-001 9993461 2030-03-29 U-4495 2023-03-14 N216403-002 9662312 2030-03-29 U-4495 2026-05-07 N216403-002 9993461 2030-03-29 U-3269 2023-03-14 N216403-002 9993461 2030-03-29 U-3993 2023-03-14 N216403-002 9993461 2030-03-29 U-4495 2023-03-14
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 8 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 2 · 50 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 N216403-001 FILSPARI 200MG TABLET / ORAL RLD 2023-02-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216403-002 FILSPARI 400MG TABLET / ORAL RLD, RS 2023-02-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216403-001 FILSPARI 200MG TABLET / ORAL RLD 2023-02-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216403-002 FILSPARI 400MG TABLET / ORAL RLD, RS 2023-02-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216403-001 FILSPARI 200MG TABLET / ORAL RLD 2023-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216403-002 FILSPARI 400MG TABLET / ORAL RLD, RS 2023-02-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216403-001 FILSPARI 200MG TABLET / ORAL RLD 2023-02-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216403-002 FILSPARI 400MG TABLET / ORAL RLD, RS 2023-02-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216403-001 FILSPARI 200MG TABLET / ORAL RLD 2023-02-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216403-002 FILSPARI 400MG TABLET / ORAL RLD, RS 2023-02-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216403-001 FILSPARI 200MG TABLET / ORAL RLD 2023-02-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216403-002 FILSPARI 400MG TABLET / ORAL RLD, RS 2023-02-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216403-001 FILSPARI 200MG TABLET / ORAL RLD 2023-02-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216403-002 FILSPARI 400MG TABLET / ORAL RLD, RS 2023-02-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216403-001 FILSPARI 200MG TABLET / ORAL RLD 2023-02-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216403-002 FILSPARI 400MG TABLET / ORAL RLD, RS 2023-02-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216403-001 FILSPARI 200MG TABLET / ORAL RLD 2023-02-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216403-002 FILSPARI 400MG TABLET / ORAL RLD, RS 2023-02-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216403-001 FILSPARI 200MG TABLET / ORAL RLD 2023-02-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216403-002 FILSPARI 400MG TABLET / ORAL RLD, RS 2023-02-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216403-001 FILSPARI 200MG TABLET / ORAL RLD 2023-02-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216403-002 FILSPARI 400MG TABLET / ORAL RLD, RS 2023-02-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216403-001 FILSPARI 200MG TABLET / ORAL RLD 2023-02-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N216403-002 FILSPARI 400MG TABLET / ORAL RLD, RS 2023-02-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216403-001 FILSPARI 200MG TABLET / ORAL RLD 2023-02-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216403-002 FILSPARI 400MG TABLET / ORAL RLD, RS 2023-02-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216403-001 FILSPARI 200MG TABLET / ORAL RLD 2023-02-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216403-002 FILSPARI 400MG TABLET / ORAL RLD, RS 2023-02-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216403-001 FILSPARI 200MG TABLET / ORAL RLD 2023-02-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216403-002 FILSPARI 400MG TABLET / ORAL RLD, RS 2023-02-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N216403-001 FILSPARI 200MG TABLET / ORAL RLD 2023-02-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N216403-002 FILSPARI 400MG TABLET / ORAL RLD, RS 2023-02-17 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N216403-001 FILSPARI 200MG TABLET / ORAL RLD 2023-02-17 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N216403-002 FILSPARI 400MG TABLET / ORAL RLD, RS 2023-02-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N216403-001 FILSPARI 200MG TABLET / ORAL RLD 2023-02-17 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N216403-002 FILSPARI 400MG TABLET / ORAL RLD, RS 2023-02-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N216403-001 FILSPARI 200MG TABLET / ORAL RLD 2023-02-17 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N216403-002 FILSPARI 400MG TABLET / ORAL RLD, RS 2023-02-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N216403-001 FILSPARI 200MG TABLET / ORAL RLD 2023-02-17 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N216403-002 FILSPARI 400MG TABLET / ORAL RLD, RS 2023-02-17 a72a2bbeb626…
Observed Orange Book patent history# Patent history page 1 of 3 · 86 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N216403-001 9662312 2030-03-29 U-4495 2026-05-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216403-001 9993461 2030-03-29 U-3269 2023-03-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216403-001 9993461 2030-03-29 U-3993 2023-03-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216403-001 9993461 2030-03-29 U-4495 2023-03-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216403-002 9662312 2030-03-29 U-4495 2026-05-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216403-002 9993461 2030-03-29 U-3269 2023-03-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216403-002 9993461 2030-03-29 U-3993 2023-03-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216403-002 9993461 2030-03-29 U-4495 2023-03-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216403-001 9662312 2030-03-29 U-4495 2026-05-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216403-001 9993461 2030-03-29 U-3269 2023-03-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216403-001 9993461 2030-03-29 U-3993 2023-03-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216403-001 9993461 2030-03-29 U-4495 2023-03-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216403-002 9662312 2030-03-29 U-4495 2026-05-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216403-002 9993461 2030-03-29 U-3269 2023-03-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216403-002 9993461 2030-03-29 U-3993 2023-03-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216403-002 9993461 2030-03-29 U-4495 2023-03-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216403-001 9993461 2030-03-29 U-3269 2023-03-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216403-001 9993461 2030-03-29 U-3993 2023-03-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216403-002 9993461 2030-03-29 U-3269 2023-03-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216403-002 9993461 2030-03-29 U-3993 2023-03-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216403-001 9993461 2030-03-29 U-3269 2023-03-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216403-001 9993461 2030-03-29 U-3993 2023-03-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216403-002 9993461 2030-03-29 U-3269 2023-03-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216403-002 9993461 2030-03-29 U-3993 2023-03-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216403-001 9993461 2030-03-29 U-3269 2023-03-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216403-001 9993461 2030-03-29 U-3993 2023-03-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216403-002 9993461 2030-03-29 U-3269 2023-03-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216403-002 9993461 2030-03-29 U-3993 2023-03-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216403-001 9993461 2030-03-29 U-3269 2023-03-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216403-001 9993461 2030-03-29 U-3993 2023-03-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216403-002 9993461 2030-03-29 U-3269 2023-03-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216403-002 9993461 2030-03-29 U-3993 2023-03-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216403-001 9993461 2030-03-29 U-3269 2023-03-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216403-001 9993461 2030-03-29 U-3993 2023-03-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216403-002 9993461 2030-03-29 U-3269 2023-03-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216403-002 9993461 2030-03-29 U-3993 2023-03-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216403-001 9993461 2030-03-29 U-3269 2023-03-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216403-001 9993461 2030-03-29 U-3993 2023-03-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216403-002 9993461 2030-03-29 U-3269 2023-03-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216403-002 9993461 2030-03-29 U-3993 2023-03-14 03ed91905a0d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 130 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 FILSPARI
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SPARSENTAN 400 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9242RO5URM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2630540 Internal RxNorm lookup 2630546 Internal RxNorm lookup 2630548 Internal RxNorm lookup 2630550 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 68974-400-30 FILSPARI 30 in 1 BOTTLE TABLET, FILM COATED 30 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68974-400 FILSPARI (SPARSENTAN) TABLET, FILM COATED [TRAVERE THERAPEUTICS, INC.] 4 Current NDC, 1 package rows 20250424_d7354af1-f304-f4d9-e053-2995a90ab219.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 FILSPARI SPARSENTAN Travere Therapeutics, Inc. d7354af1-f304-f4d9-e053-2995a90ab219 2026-04-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 216403 application number: NDA216403 ndc (product): 68974-400
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 68974-400-30 68974040030 30 TABLET, FILM COATED in 1 BOTTLE (68974-400-30) 2023-02-17 No No Current