Home NDC 81927-204 JYLAMVO
Product NDC 81927-204
11-digit product format 819270204
Labeler code 81927
Product ID 81927-204_3a5966e9-256b-4595-b962-e00d07526623
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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N212479-001 JYLAMVO METHOTREXATE 2MG/ML SOLUTION / ORAL RLD, RS 2022-11-29
Orange Book patents# Current patent rows page 1 of 1 · 7 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N212479-001 11771701 2034-10-29 U-3700 Drug product 2023-10-20 N212479-001 11771701 2034-10-29 U-3701 Drug product 2023-10-20 N212479-001 11771701 2034-10-29 U-3702 Drug product 2023-10-20 N212479-001 11771701 2034-10-29 U-3703 Drug product 2023-10-20 N212479-001 11771701 2034-10-29 U-3704 Drug product 2023-10-20 N212479-001 12605385 2035-10-25 Drug product 2026-05-15 N212479-001 11129833 2035-10-28 Drug product 2023-08-22
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N212479-001 JYLAMVO 2MG/ML SOLUTION / ORAL RLD, RS 2022-11-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212479-001 JYLAMVO 2MG/ML SOLUTION / ORAL RLD, RS 2022-11-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212479-001 JYLAMVO 2MG/ML SOLUTION / ORAL RLD, RS 2022-11-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212479-001 JYLAMVO 2MG/ML SOLUTION / ORAL RLD, RS 2022-11-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212479-001 JYLAMVO 2MG/ML SOLUTION / ORAL RLD, RS 2022-11-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212479-001 JYLAMVO 2MG/ML SOLUTION / ORAL RLD, RS 2022-11-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212479-001 JYLAMVO 2MG/ML SOLUTION / ORAL RLD, RS 2022-11-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212479-001 JYLAMVO 2MG/ML SOLUTION / ORAL RLD, RS 2022-11-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212479-001 JYLAMVO 2MG/ML SOLUTION / ORAL RLD, RS 2022-11-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212479-001 JYLAMVO 2MG/ML SOLUTION / ORAL RLD, RS 2022-11-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212479-001 JYLAMVO 2MG/ML SOLUTION / ORAL RLD, RS 2022-11-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212479-001 JYLAMVO 2MG/ML SOLUTION / ORAL RLD, RS 2022-11-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212479-001 JYLAMVO 2MG/ML SOLUTION / ORAL RLD, RS 2022-11-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212479-001 JYLAMVO 2MG/ML SOLUTION / ORAL RLD, RS 2022-11-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212479-001 JYLAMVO 2MG/ML SOLUTION / ORAL RLD, RS 2022-11-29 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N212479-001 JYLAMVO 2MG/ML SOLUTION / ORAL RLD, RS 2022-11-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N212479-001 JYLAMVO 2MG/ML SOLUTION / ORAL RLD, RS 2022-11-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N212479-001 JYLAMVO 2MG/ML SOLUTION / ORAL RLD, RS 2022-11-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N212479-001 JYLAMVO 2MG/ML SOLUTION / ORAL RLD, RS 2022-11-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N212479-001 JYLAMVO 2MG/ML SOLUTION / ORAL RLD 2022-11-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N212479-001 JYLAMVO 2MG/ML SOLUTION / ORAL RLD 2022-11-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N212479-001 JYLAMVO 2MG/ML SOLUTION / ORAL RLD 2022-11-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N212479-001 JYLAMVO 2MG/ML SOLUTION / ORAL RLD, RS 2022-11-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N212479-001 JYLAMVO 2MG/ML SOLUTION / ORAL RLD, RS 2022-11-29 3bdfa0b2c4d7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N212479-001 JYLAMVO 2MG/ML SOLUTION / ORAL RLD, RS 2022-11-29 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 4 · 123 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N212479-001 11771701 2034-10-29 U-3700 Drug product 2023-10-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212479-001 11771701 2034-10-29 U-3701 Drug product 2023-10-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212479-001 11771701 2034-10-29 U-3702 Drug product 2023-10-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212479-001 11771701 2034-10-29 U-3703 Drug product 2023-10-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212479-001 11771701 2034-10-29 U-3704 Drug product 2023-10-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212479-001 12605385 2035-10-25 Drug product 2026-05-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212479-001 11129833 2035-10-28 Drug product 2023-08-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212479-001 11771701 2034-10-29 U-3700 Drug product 2023-10-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212479-001 11771701 2034-10-29 U-3701 Drug product 2023-10-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212479-001 11771701 2034-10-29 U-3702 Drug product 2023-10-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212479-001 11771701 2034-10-29 U-3703 Drug product 2023-10-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212479-001 11771701 2034-10-29 U-3704 Drug product 2023-10-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212479-001 11129833 2035-10-28 Drug product 2023-08-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212479-001 11771701 2034-10-29 U-3700 Drug product 2023-10-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212479-001 11771701 2034-10-29 U-3701 Drug product 2023-10-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212479-001 11771701 2034-10-29 U-3702 Drug product 2023-10-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212479-001 11771701 2034-10-29 U-3703 Drug product 2023-10-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212479-001 11771701 2034-10-29 U-3704 Drug product 2023-10-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212479-001 11129833 2035-10-28 Drug product 2023-08-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212479-001 11771701 2034-10-29 U-3700 Drug product 2023-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212479-001 11771701 2034-10-29 U-3701 Drug product 2023-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212479-001 11771701 2034-10-29 U-3702 Drug product 2023-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212479-001 11771701 2034-10-29 U-3703 Drug product 2023-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212479-001 11771701 2034-10-29 U-3704 Drug product 2023-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212479-001 11129833 2035-10-28 Drug product 2023-08-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212479-001 11771701 2034-10-29 U-3700 Drug product 2023-10-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212479-001 11771701 2034-10-29 U-3701 Drug product 2023-10-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212479-001 11771701 2034-10-29 U-3702 Drug product 2023-10-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212479-001 11771701 2034-10-29 U-3703 Drug product 2023-10-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212479-001 11771701 2034-10-29 U-3704 Drug product 2023-10-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212479-001 11129833 2035-10-28 Drug product 2023-08-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212479-001 11771701 2034-10-29 U-3700 Drug product 2023-10-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212479-001 11771701 2034-10-29 U-3701 Drug product 2023-10-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212479-001 11771701 2034-10-29 U-3702 Drug product 2023-10-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212479-001 11771701 2034-10-29 U-3703 Drug product 2023-10-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212479-001 11771701 2034-10-29 U-3704 Drug product 2023-10-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212479-001 11129833 2035-10-28 Drug product 2023-08-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212479-001 11771701 2034-10-29 U-3700 Drug product 2023-10-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212479-001 11771701 2034-10-29 U-3701 Drug product 2023-10-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212479-001 11771701 2034-10-29 U-3702 Drug product 2023-10-20 03ed91905a0d…
Additional Listing Data#
Finished product Yes
Brand name base JYLAMVO
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHOTREXATE 2 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination YL5FZ2Y5U1 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2671456 Internal RxNorm lookup 2671462 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 81927-204-01 JYLAMVO 1 in 1 CARTON SOLUTION 1 10 81927-204-01 JYLAMVO 60 mL in 1 BOTTLE, GLASS SOLUTION 60 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81927-204 JYLAMVO (METHOTREXATE) SOLUTION [SHORLA ONCOLOGY INC.] 9 Current NDC, 2 package rows 20250502_96e931f5-51ae-4bdf-a441-bb0dd26d4c0e.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 JYLAMVO METHOTREXATE SHORLA ONCOLOGY INC. 96e931f5-51ae-4bdf-a441-bb0dd26d4c0e 2026-06-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 212479 application number: NDA212479 ndc (product): 81927-204
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 81927-204-01 81927020401 1 BOTTLE, GLASS in 1 CARTON (81927-204-01) / 60 mL in 1 BOTTLE, GLASS 2023-12-15 No No Current