JASCAYD

Product NDC
0597-2465
Requested package NDC
0597-2465-41
11-digit product format
005972465
Labeler code
0597
Product ID
0597-2465_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
9 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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N218764-001JASCAYDNERANDOMILAST9MGTABLET / ORALRLD2025-10-07
N218764-002JASCAYDNERANDOMILAST18MGTABLET / ORALRLD, RS2025-10-07

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N218764-00187540732029-11-26U-4298Drug substance, Drug product2025-10-29
N218764-00186096702032-08-23Drug substance2025-10-29
N218764-00198029542034-02-19U-42982025-10-29
N218764-001114066382038-10-22U-42972025-10-29
N218764-001114066382038-10-22U-43732025-10-29
N218764-001118132662038-10-22U-42922025-10-29
N218764-001118132662038-10-22U-43722025-10-29
N218764-00287540732029-11-26U-4298Drug substance, Drug product2025-10-29
N218764-00286096702032-08-23Drug substance2025-10-29
N218764-00298029542034-02-19U-42982025-10-29
N218764-002114066382038-10-22U-42972025-10-29
N218764-002114066382038-10-22U-43732025-10-29
N218764-002118132662038-10-22U-42922025-10-29
N218764-002118132662038-10-22U-43722025-10-29

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 6 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N218764-001I-9792028-12-19
N218764-001NCE2030-10-07
N218764-001ODE-5462032-10-07
N218764-002I-9792028-12-19
N218764-002NCE2030-10-07
N218764-002ODE-5462032-10-07

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N218764-001JASCAYD9MGTABLET / ORALRLD2025-10-0784e616aacf4f…
2026-09-14 22:38:342026-08N218764-002JASCAYD18MGTABLET / ORALRLD, RS2025-10-0784e616aacf4f…
2026-08-18 06:07:402026-07N218764-001JASCAYD9MGTABLET / ORALRLD2025-10-07caaa826d4ba7…
2026-08-18 06:07:402026-07N218764-002JASCAYD18MGTABLET / ORALRLD, RS2025-10-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218764-001JASCAYD9MGTABLET / ORALRLD2025-10-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218764-002JASCAYD18MGTABLET / ORALRLD, RS2025-10-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218764-001JASCAYD9MGTABLET / ORALRLD2025-10-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218764-002JASCAYD18MGTABLET / ORALRLD, RS2025-10-0731067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218764-001JASCAYD9MGTABLET / ORALRLD2025-10-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218764-002JASCAYD18MGTABLET / ORALRLD, RS2025-10-07a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N218764-00187540732029-11-26U-4298Drug substance, Drug product2025-10-2984e616aacf4f…
2026-09-14 22:38:342026-08N218764-00186096702032-08-23Drug substance2025-10-2984e616aacf4f…
2026-09-14 22:38:342026-08N218764-00198029542034-02-19U-42982025-10-2984e616aacf4f…
2026-09-14 22:38:342026-08N218764-001114066382038-10-22U-43732025-10-2984e616aacf4f…
2026-09-14 22:38:342026-08N218764-001114066382038-10-22U-42972025-10-2984e616aacf4f…
2026-09-14 22:38:342026-08N218764-001118132662038-10-22U-43722025-10-2984e616aacf4f…
2026-09-14 22:38:342026-08N218764-001118132662038-10-22U-42922025-10-2984e616aacf4f…
2026-09-14 22:38:342026-08N218764-00287540732029-11-26U-4298Drug substance, Drug product2025-10-2984e616aacf4f…
2026-09-14 22:38:342026-08N218764-00286096702032-08-23Drug substance2025-10-2984e616aacf4f…
2026-09-14 22:38:342026-08N218764-00298029542034-02-19U-42982025-10-2984e616aacf4f…
2026-09-14 22:38:342026-08N218764-002114066382038-10-22U-43732025-10-2984e616aacf4f…
2026-09-14 22:38:342026-08N218764-002114066382038-10-22U-42972025-10-2984e616aacf4f…
2026-09-14 22:38:342026-08N218764-002118132662038-10-22U-43722025-10-2984e616aacf4f…
2026-09-14 22:38:342026-08N218764-002118132662038-10-22U-42922025-10-2984e616aacf4f…
2026-08-18 06:07:402026-07N218764-00187540732029-11-26U-4298Drug substance, Drug product2025-10-29caaa826d4ba7…
2026-08-18 06:07:402026-07N218764-00186096702032-08-23Drug substance2025-10-29caaa826d4ba7…
2026-08-18 06:07:402026-07N218764-00198029542034-02-19U-42982025-10-29caaa826d4ba7…
2026-08-18 06:07:402026-07N218764-001114066382038-10-22U-43732025-10-29caaa826d4ba7…
2026-08-18 06:07:402026-07N218764-001114066382038-10-22U-42972025-10-29caaa826d4ba7…
2026-08-18 06:07:402026-07N218764-001118132662038-10-22U-43722025-10-29caaa826d4ba7…
2026-08-18 06:07:402026-07N218764-001118132662038-10-22U-42922025-10-29caaa826d4ba7…
2026-08-18 06:07:402026-07N218764-00287540732029-11-26U-4298Drug substance, Drug product2025-10-29caaa826d4ba7…
2026-08-18 06:07:402026-07N218764-00286096702032-08-23Drug substance2025-10-29caaa826d4ba7…
2026-08-18 06:07:402026-07N218764-00298029542034-02-19U-42982025-10-29caaa826d4ba7…
2026-08-18 06:07:402026-07N218764-002114066382038-10-22U-43732025-10-29caaa826d4ba7…
2026-08-18 06:07:402026-07N218764-002114066382038-10-22U-42972025-10-29caaa826d4ba7…
2026-08-18 06:07:402026-07N218764-002118132662038-10-22U-43722025-10-29caaa826d4ba7…
2026-08-18 06:07:402026-07N218764-002118132662038-10-22U-42922025-10-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218764-00187540732029-11-26U-4298Drug substance, Drug product2025-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218764-00186096702032-08-23Drug substance2025-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218764-00198029542034-02-19U-42982025-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218764-001114066382038-10-22U-43732025-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218764-001114066382038-10-22U-42972025-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218764-001118132662038-10-22U-43722025-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218764-001118132662038-10-22U-42922025-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218764-00287540732029-11-26U-4298Drug substance, Drug product2025-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218764-00286096702032-08-23Drug substance2025-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218764-00298029542034-02-19U-42982025-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218764-002114066382038-10-22U-43732025-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218764-002114066382038-10-22U-42972025-10-29011fe1cb6892…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N218764-001I-9792028-12-1984e616aacf4f…
2026-09-14 22:38:342026-08N218764-001NCE2030-10-0784e616aacf4f…
2026-09-14 22:38:342026-08N218764-001ODE-5462032-10-0784e616aacf4f…
2026-09-14 22:38:342026-08N218764-002I-9792028-12-1984e616aacf4f…
2026-09-14 22:38:342026-08N218764-002NCE2030-10-0784e616aacf4f…
2026-09-14 22:38:342026-08N218764-002ODE-5462032-10-0784e616aacf4f…
2026-08-18 06:07:402026-07N218764-001I-9792028-12-19caaa826d4ba7…
2026-08-18 06:07:402026-07N218764-001NCE2030-10-07caaa826d4ba7…
2026-08-18 06:07:402026-07N218764-001ODE-5462032-10-07caaa826d4ba7…
2026-08-18 06:07:402026-07N218764-002I-9792028-12-19caaa826d4ba7…
2026-08-18 06:07:402026-07N218764-002NCE2030-10-07caaa826d4ba7…
2026-08-18 06:07:402026-07N218764-002ODE-5462032-10-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218764-001I-9792028-12-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218764-001NCE2030-10-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218764-002I-9792028-12-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218764-002NCE2030-10-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218764-001NCE2030-10-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218764-002NCE2030-10-0731067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218764-001I-9792028-12-19a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218764-001NCE2030-10-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218764-001ODE-5462032-10-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218764-002I-9792028-12-19a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218764-002NCE2030-10-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218764-002ODE-5462032-10-07a50c72e98297…

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
IngredientStrength
NERANDOMILAST9 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
I5DGT51IB8Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2725528Internal RxNorm lookup
2725534Internal RxNorm lookup
2725537Internal RxNorm lookup
2725539Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
fa1b14c6-957f-d326-5099-911bfe33e391Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0597-2465-41JASCAYD60 in 1 BOTTLE, PLASTICTABLET, FILM COATED604
0597-2465-41JASCAYD1 in 1 CARTONTABLET, FILM COATED14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0597-2465-41EA - Each0597-2465701102da-5347-4a4b-9a99-e2902a77744912025-11-13

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JASCAYDNERANDOMILASTBoehringer Ingelheim Pharmaceuticals, Inc.fa1b14c6-957f-d326-5099-911bfe33e3912026-08-14Adverse reactionsExact identifier
application applno (NDA): 218764
application number: NDA218764
ndc (package): 0597-2465-41
ndc (product): 0597-2465
ndc11 (package): 00597246541

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2725539JASCAYD 18 MG Oral TabletPSNfa1b14c6-957f-d326-5099-911bfe33e3914
2725534JASCAYD 9 MG Oral TabletPSNfa1b14c6-957f-d326-5099-911bfe33e3914
2725537nerandomilast 18 MG Oral TabletPSNfa1b14c6-957f-d326-5099-911bfe33e3914
2725528nerandomilast 9 MG Oral TabletPSNfa1b14c6-957f-d326-5099-911bfe33e3914
2725539nerandomilast 18 MG Oral Tablet [Jascayd]SBDfa1b14c6-957f-d326-5099-911bfe33e3914
2725534nerandomilast 9 MG Oral Tablet [Jascayd]SBDfa1b14c6-957f-d326-5099-911bfe33e3914
2725537nerandomilast 18 MG Oral TabletSCDfa1b14c6-957f-d326-5099-911bfe33e3914
2725528nerandomilast 9 MG Oral TabletSCDfa1b14c6-957f-d326-5099-911bfe33e3914
2725539Jascayd 18 MG Oral TabletSYfa1b14c6-957f-d326-5099-911bfe33e3914
2725534Jascayd 9 MG Oral TabletSYfa1b14c6-957f-d326-5099-911bfe33e3914

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0597-2465-41005972465411 BOTTLE, PLASTIC in 1 CARTON (0597-2465-41) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2025-10-07NoNoCurrent