FDA.reportPublic FDA data

JYLAMVO

Product NDC
81927-204
11-digit product format
819270204
Labeler code
81927
Product ID
81927-204_5f874f40-3b32-f9d2-e063-6394a90ad346
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methotrexate
Dosage form
SOLUTION
Route
ORAL
Labeler
SHORLA ONCOLOGY INC.
Application
NDA212479
Marketing category
NDA
Marketing start
2023-12-15
Substance
METHOTREXATE
Active strength
2 mg/mL
Pharmacologic classes
Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism 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 45.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N212479-001JYLAMVOMETHOTREXATE2MG/MLSOLUTION / ORALRLD, RS2022-11-29

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N212479-001117717012034-10-29U-3700Drug product2023-10-20
N212479-001117717012034-10-29U-3701Drug product2023-10-20
N212479-001117717012034-10-29U-3702Drug product2023-10-20
N212479-001117717012034-10-29U-3703Drug product2023-10-20
N212479-001117717012034-10-29U-3704Drug product2023-10-20
N212479-001126053852035-10-25Drug product2026-05-15
N212479-001111298332035-10-28Drug product2023-08-22

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
2026-11-14 07:37:172026-10N212479-001JYLAMVO2MG/MLSOLUTION / ORALRLD, RS2022-11-29d4dbc9d85df4…
2026-10-15 13:18:302026-09N212479-001JYLAMVO2MG/MLSOLUTION / ORALRLD, RS2022-11-29c2088c7a36db…
2026-09-14 22:38:342026-08N212479-001JYLAMVO2MG/MLSOLUTION / ORALRLD, RS2022-11-2984e616aacf4f…
2026-08-18 06:07:402026-07N212479-001JYLAMVO2MG/MLSOLUTION / ORALRLD, RS2022-11-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N212479-001JYLAMVO2MG/MLSOLUTION / ORALRLD, RS2022-11-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212479-001JYLAMVO2MG/MLSOLUTION / ORALRLD, RS2022-11-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N212479-001JYLAMVO2MG/MLSOLUTION / ORALRLD, RS2022-11-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N212479-001JYLAMVO2MG/MLSOLUTION / ORALRLD, RS2022-11-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N212479-001JYLAMVO2MG/MLSOLUTION / ORALRLD, RS2022-11-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N212479-001JYLAMVO2MG/MLSOLUTION / ORALRLD, RS2022-11-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N212479-001JYLAMVO2MG/MLSOLUTION / ORALRLD, RS2022-11-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N212479-001JYLAMVO2MG/MLSOLUTION / ORALRLD, RS2022-11-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N212479-001JYLAMVO2MG/MLSOLUTION / ORALRLD, RS2022-11-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N212479-001JYLAMVO2MG/MLSOLUTION / ORALRLD, RS2022-11-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N212479-001JYLAMVO2MG/MLSOLUTION / ORALRLD, RS2022-11-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N212479-001JYLAMVO2MG/MLSOLUTION / ORALRLD, RS2022-11-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N212479-001JYLAMVO2MG/MLSOLUTION / ORALRLD, RS2022-11-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05N212479-001JYLAMVO2MG/MLSOLUTION / ORALRLD, RS2022-11-298072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N212479-001JYLAMVO2MG/MLSOLUTION / ORALRLD, RS2022-11-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N212479-001JYLAMVO2MG/MLSOLUTION / ORALRLD, RS2022-11-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12N212479-001JYLAMVO2MG/MLSOLUTION / ORALRLD, RS2022-11-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N212479-001JYLAMVO2MG/MLSOLUTION / ORALRLD, RS2022-11-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N212479-001JYLAMVO2MG/MLSOLUTION / ORALRLD2022-11-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N212479-001JYLAMVO2MG/MLSOLUTION / ORALRLD2022-11-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N212479-001JYLAMVO2MG/MLSOLUTION / ORALRLD2022-11-293f0d92c62455…
2023-05-13 08:27 UTC2023-05N212479-001JYLAMVO2MG/MLSOLUTION / ORALRLD, RS2022-11-29053a50430f4f…
2023-01-26 05:58 UTC2023-01N212479-001JYLAMVO2MG/MLSOLUTION / ORALRLD, RS2022-11-293bdfa0b2c4d7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N212479-001JYLAMVO2MG/MLSOLUTION / ORALRLD, RS2022-11-29a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 4 · 144 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-11-14 07:37:172026-10N212479-001117717012034-10-29U-3700Drug product2023-10-20d4dbc9d85df4…
2026-11-14 07:37:172026-10N212479-001117717012034-10-29U-3701Drug product2023-10-20d4dbc9d85df4…
2026-11-14 07:37:172026-10N212479-001117717012034-10-29U-3702Drug product2023-10-20d4dbc9d85df4…
2026-11-14 07:37:172026-10N212479-001117717012034-10-29U-3703Drug product2023-10-20d4dbc9d85df4…
2026-11-14 07:37:172026-10N212479-001117717012034-10-29U-3704Drug product2023-10-20d4dbc9d85df4…
2026-11-14 07:37:172026-10N212479-001126053852035-10-25Drug product2026-05-15d4dbc9d85df4…
2026-11-14 07:37:172026-10N212479-001111298332035-10-28Drug product2023-08-22d4dbc9d85df4…
2026-10-15 13:18:302026-09N212479-001117717012034-10-29U-3700Drug product2023-10-20c2088c7a36db…
2026-10-15 13:18:302026-09N212479-001117717012034-10-29U-3701Drug product2023-10-20c2088c7a36db…
2026-10-15 13:18:302026-09N212479-001117717012034-10-29U-3702Drug product2023-10-20c2088c7a36db…
2026-10-15 13:18:302026-09N212479-001117717012034-10-29U-3703Drug product2023-10-20c2088c7a36db…
2026-10-15 13:18:302026-09N212479-001117717012034-10-29U-3704Drug product2023-10-20c2088c7a36db…
2026-10-15 13:18:302026-09N212479-001126053852035-10-25Drug product2026-05-15c2088c7a36db…
2026-10-15 13:18:302026-09N212479-001111298332035-10-28Drug product2023-08-22c2088c7a36db…
2026-09-14 22:38:342026-08N212479-001117717012034-10-29U-3700Drug product2023-10-2084e616aacf4f…
2026-09-14 22:38:342026-08N212479-001117717012034-10-29U-3701Drug product2023-10-2084e616aacf4f…
2026-09-14 22:38:342026-08N212479-001117717012034-10-29U-3702Drug product2023-10-2084e616aacf4f…
2026-09-14 22:38:342026-08N212479-001117717012034-10-29U-3703Drug product2023-10-2084e616aacf4f…
2026-09-14 22:38:342026-08N212479-001117717012034-10-29U-3704Drug product2023-10-2084e616aacf4f…
2026-09-14 22:38:342026-08N212479-001126053852035-10-25Drug product2026-05-1584e616aacf4f…
2026-09-14 22:38:342026-08N212479-001111298332035-10-28Drug product2023-08-2284e616aacf4f…
2026-08-18 06:07:402026-07N212479-001117717012034-10-29U-3700Drug product2023-10-20caaa826d4ba7…
2026-08-18 06:07:402026-07N212479-001117717012034-10-29U-3701Drug product2023-10-20caaa826d4ba7…
2026-08-18 06:07:402026-07N212479-001117717012034-10-29U-3702Drug product2023-10-20caaa826d4ba7…
2026-08-18 06:07:402026-07N212479-001117717012034-10-29U-3703Drug product2023-10-20caaa826d4ba7…
2026-08-18 06:07:402026-07N212479-001117717012034-10-29U-3704Drug product2023-10-20caaa826d4ba7…
2026-08-18 06:07:402026-07N212479-001126053852035-10-25Drug product2026-05-15caaa826d4ba7…
2026-08-18 06:07:402026-07N212479-001111298332035-10-28Drug product2023-08-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N212479-001117717012034-10-29U-3700Drug product2023-10-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212479-001117717012034-10-29U-3701Drug product2023-10-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212479-001117717012034-10-29U-3702Drug product2023-10-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212479-001117717012034-10-29U-3703Drug product2023-10-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212479-001117717012034-10-29U-3704Drug product2023-10-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212479-001111298332035-10-28Drug product2023-08-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212479-001117717012034-10-29U-3700Drug product2023-10-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212479-001117717012034-10-29U-3701Drug product2023-10-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212479-001117717012034-10-29U-3702Drug product2023-10-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212479-001117717012034-10-29U-3703Drug product2023-10-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212479-001117717012034-10-29U-3704Drug product2023-10-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212479-001111298332035-10-28Drug product2023-08-2231067a03dcf5…

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
JYLAMVO
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHOTREXATE2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
YL5FZ2Y5U1Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2671456Internal RxNorm lookup
2671462Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
96e931f5-51ae-4bdf-a441-bb0dd26d4c0eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2eb9a854-4fbc-9bbe-3199-41fc1018a1f0Product name920250224
3082de91-569a-4d57-b379-acbf37f1d5c3Product name120210312
f76135bc-a210-42d9-851b-1b73cbaccdb3Product name120200511
423544b2-e325-49ee-8910-4c5dfe41906fProduct name120181120
c9fd924b-0a8d-4d53-bf70-11070e24e4ddProduct name220181120
ce1e7cc6-4850-4cb1-8dde-8010b2fbc359Product name120181120
eb454f54-2806-4c31-a08b-8dcb08261099Product name220181120
d9cebc09-c68d-46f5-bdcd-fd82e945cc27Product name120170705
16ba0c1e-2371-48a4-8b4c-a9a338dfe1f3Product name220160504
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
88514aea-9d58-4ed2-b135-9811fb14c8fbProduct name120141209
0eba90a2-1cca-7e7b-28a5-85a09e2bc9a4Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81927-204-01JYLAMVO1 in 1 CARTONSOLUTION110
81927-204-01JYLAMVO60 mL in 1 BOTTLE, GLASSSOLUTION6010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81927-204-01ML - Milliliter81927-20422cc5d6e-613d-4996-bcb5-9c7fb6b8ebe712023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81927-204JYLAMVO (METHOTREXATE) SOLUTION [SHORLA ONCOLOGY INC.]9Current NDC, 2 package rows20250502_96e931f5-51ae-4bdf-a441-bb0dd26d4c0e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2671462Jylamvo 2 MG in 1 mL Oral SolutionPSN96e931f5-51ae-4bdf-a441-bb0dd26d4c0e10
2671456methotrexate 2 MG in 1 mL Oral SolutionPSN96e931f5-51ae-4bdf-a441-bb0dd26d4c0e10
2671462methotrexate 2 MG/ML Oral Solution [Jylamvo]SBD96e931f5-51ae-4bdf-a441-bb0dd26d4c0e10
2671456methotrexate 2 MG/ML Oral SolutionSCD96e931f5-51ae-4bdf-a441-bb0dd26d4c0e10
2671462Jylamvo 2 MG per 1 ML Oral SolutionSY96e931f5-51ae-4bdf-a441-bb0dd26d4c0e10
2671456methotrexate 2 MG per 1 ML Oral SolutionSY96e931f5-51ae-4bdf-a441-bb0dd26d4c0e10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
81927-204-01819270204011 BOTTLE, GLASS in 1 CARTON (81927-204-01) / 60 mL in 1 BOTTLE, GLASS2023-12-15NoNoCurrent