Home NDC 0597-7313 JASCAYD
Product NDC 0597-7313
11-digit product format 005977313
Labeler code 0597
Product ID 0597-7313_7ec9d75b-ba99-4670-9b69-4bf9089232b7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nerandomilast
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Boehringer Ingelheim Pharmaceuticals, Inc.
Application NDA218764
Marketing category NDA
Marketing start 2025-10-07
Substance NERANDOMILAST
Active strength 18 mg/1
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 N218764-001 JASCAYD NERANDOMILAST 9MG TABLET / ORAL RLD 2025-10-07 N218764-002 JASCAYD NERANDOMILAST 18MG TABLET / ORAL RLD, RS 2025-10-07
Orange Book patents# Current patent rows page 1 of 1 · 14 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N218764-001 8754073 2029-11-26 U-4298 Drug substance, Drug product 2025-10-29 N218764-001 8609670 2032-08-23 Drug substance 2025-10-29 N218764-001 9802954 2034-02-19 U-4298 2025-10-29 N218764-001 11406638 2038-10-22 U-4297 2025-10-29 N218764-001 11406638 2038-10-22 U-4373 2025-10-29 N218764-001 11813266 2038-10-22 U-4292 2025-10-29 N218764-001 11813266 2038-10-22 U-4372 2025-10-29 N218764-002 8754073 2029-11-26 U-4298 Drug substance, Drug product 2025-10-29 N218764-002 8609670 2032-08-23 Drug substance 2025-10-29 N218764-002 9802954 2034-02-19 U-4298 2025-10-29 N218764-002 11406638 2038-10-22 U-4297 2025-10-29 N218764-002 11406638 2038-10-22 U-4373 2025-10-29 N218764-002 11813266 2038-10-22 U-4292 2025-10-29 N218764-002 11813266 2038-10-22 U-4372 2025-10-29
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 6 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.
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 N218764-001 JASCAYD 9MG TABLET / ORAL RLD 2025-10-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218764-002 JASCAYD 18MG TABLET / ORAL RLD, RS 2025-10-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 N218764-001 JASCAYD 9MG TABLET / ORAL RLD 2025-10-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218764-002 JASCAYD 18MG TABLET / ORAL RLD, RS 2025-10-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218764-001 JASCAYD 9MG TABLET / ORAL RLD 2025-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218764-002 JASCAYD 18MG TABLET / ORAL RLD, RS 2025-10-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218764-001 JASCAYD 9MG TABLET / ORAL RLD 2025-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218764-002 JASCAYD 18MG TABLET / ORAL RLD, RS 2025-10-07 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218764-001 JASCAYD 9MG TABLET / ORAL RLD 2025-10-07 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218764-002 JASCAYD 18MG TABLET / ORAL RLD, RS 2025-10-07 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 66 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 N218764-001 8754073 2029-11-26 U-4298 Drug substance, Drug product 2025-10-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218764-001 8609670 2032-08-23 Drug substance 2025-10-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218764-001 9802954 2034-02-19 U-4298 2025-10-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218764-001 11406638 2038-10-22 U-4373 2025-10-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218764-001 11406638 2038-10-22 U-4297 2025-10-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218764-001 11813266 2038-10-22 U-4372 2025-10-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218764-001 11813266 2038-10-22 U-4292 2025-10-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218764-002 8754073 2029-11-26 U-4298 Drug substance, Drug product 2025-10-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218764-002 8609670 2032-08-23 Drug substance 2025-10-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218764-002 9802954 2034-02-19 U-4298 2025-10-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218764-002 11406638 2038-10-22 U-4373 2025-10-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218764-002 11406638 2038-10-22 U-4297 2025-10-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218764-002 11813266 2038-10-22 U-4372 2025-10-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218764-002 11813266 2038-10-22 U-4292 2025-10-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 N218764-001 8754073 2029-11-26 U-4298 Drug substance, Drug product 2025-10-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218764-001 8609670 2032-08-23 Drug substance 2025-10-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218764-001 9802954 2034-02-19 U-4298 2025-10-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218764-001 11406638 2038-10-22 U-4373 2025-10-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218764-001 11406638 2038-10-22 U-4297 2025-10-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218764-001 11813266 2038-10-22 U-4372 2025-10-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218764-001 11813266 2038-10-22 U-4292 2025-10-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218764-002 8754073 2029-11-26 U-4298 Drug substance, Drug product 2025-10-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218764-002 8609670 2032-08-23 Drug substance 2025-10-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218764-002 9802954 2034-02-19 U-4298 2025-10-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218764-002 11406638 2038-10-22 U-4373 2025-10-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218764-002 11406638 2038-10-22 U-4297 2025-10-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218764-002 11813266 2038-10-22 U-4372 2025-10-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218764-002 11813266 2038-10-22 U-4292 2025-10-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218764-001 8754073 2029-11-26 U-4298 Drug substance, Drug product 2025-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218764-001 8609670 2032-08-23 Drug substance 2025-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218764-001 9802954 2034-02-19 U-4298 2025-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218764-001 11406638 2038-10-22 U-4373 2025-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218764-001 11406638 2038-10-22 U-4297 2025-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218764-001 11813266 2038-10-22 U-4372 2025-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218764-001 11813266 2038-10-22 U-4292 2025-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218764-002 8754073 2029-11-26 U-4298 Drug substance, Drug product 2025-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218764-002 8609670 2032-08-23 Drug substance 2025-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218764-002 9802954 2034-02-19 U-4298 2025-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218764-002 11406638 2038-10-22 U-4373 2025-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218764-002 11406638 2038-10-22 U-4297 2025-10-29 011fe1cb6892…
Observed Orange Book exclusivity 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 JASCAYD
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NERANDOMILAST 18 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination I5DGT51IB8 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2725528 Internal RxNorm lookup 2725534 Internal RxNorm lookup 2725537 Internal RxNorm lookup 2725539 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0597-7313-21 JASCAYD 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 4 0597-7313-21 JASCAYD 1 in 1 CARTON TABLET, FILM COATED 1 4
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 JASCAYD NERANDOMILAST Boehringer Ingelheim Pharmaceuticals, Inc. fa1b14c6-957f-d326-5099-911bfe33e391 2026-08-14 Adverse reactions Exact identifier application applno (NDA): 218764 application number: NDA218764 ndc (product): 0597-7313
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0597-7313-21 00597731321 1 BOTTLE, PLASTIC in 1 CARTON (0597-7313-21) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2025-10-07 No No Current