Home NDC 81927-201 IMKELDI
Product NDC 81927-201
11-digit product format 819270201
Labeler code 81927
Product ID 81927-201_dead98c8-2ac0-4fe6-890a-cc8c92ddcffc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name imatinib oral
Dosage form SOLUTION
Route ORAL
Labeler Shorla Oncology Inc.,
Application NDA219097
Marketing category NDA
Marketing start 2024-12-19
Substance IMATINIB MESYLATE
Active strength 80 mg/mL
Pharmacologic classes Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC]
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 1 .
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 N219097-001 IMKELDI IMATINIB MESYLATE EQ 80MG BASE/ML SOLUTION / ORAL RLD, RS 2024-11-22
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N219097-001 11957681 2040-04-27 Drug product 2024-11-27
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 2026-02-19 14:30 UTC 2026-02 N219097-001 IMKELDI EQ 80MG BASE/ML SOLUTION / ORAL RLD, RS 2024-11-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219097-001 IMKELDI EQ 80MG BASE/ML SOLUTION / ORAL RLD, RS 2024-11-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N219097-001 IMKELDI EQ 80MG BASE/ML SOLUTION / ORAL RLD, RS 2024-11-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N219097-001 IMKELDI EQ 80MG BASE/ML SOLUTION / ORAL RLD, RS 2024-11-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N219097-001 IMKELDI EQ 80MG BASE/ML SOLUTION / ORAL RLD, RS 2024-11-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N219097-001 IMKELDI EQ 80MG BASE/ML SOLUTION / ORAL RLD, RS 2024-11-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N219097-001 IMKELDI EQ 80MG BASE/ML SOLUTION / ORAL RLD, RS 2024-11-22 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219097-001 IMKELDI EQ 80MG BASE/ML SOLUTION / ORAL RLD, RS 2024-11-22 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N219097-001 11957681 2040-04-27 Drug product 2024-11-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219097-001 11957681 2040-04-27 Drug product 2024-11-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N219097-001 11957681 2040-04-27 Drug product 2024-11-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N219097-001 11957681 2040-04-27 Drug product 2024-11-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N219097-001 11957681 2040-04-27 Drug product 2024-11-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N219097-001 11957681 2040-04-27 Drug product 2024-11-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N219097-001 11957681 2040-04-27 Drug product 2024-11-27 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219097-001 11957681 2040-04-27 Drug product 2024-11-27 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base IMKELDI
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IMATINIB MESYLATE 80 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8A1O1M485B Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2699831 Internal RxNorm lookup 2699837 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 81927-201-01 IMKELDI 140 mL in 1 BOTTLE SOLUTION 140 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81927-201 IMKELDI (IMATINIB ORAL) SOLUTION [SHORLA ONCOLOGY INC.,] 2 Current NDC, 1 package rows 20241220_26658bb7-9ba1-a10e-e063-6394a90a172e.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 81927-201-01 81927020101 140 mL in 1 BOTTLE (81927-201-01) 140 ml 2024-12-19 No No Current