Home NDC 81864-101 Ojjaara
Product NDC 81864-101
11-digit product format 818640101
Labeler code 81864
Product ID 81864-101_3921e23f-5c82-4e00-9611-f017ff57c06e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Momelotinib
Dosage form TABLET
Route ORAL
Labeler GlaxoSmithKline LLC
Application NDA216873
Marketing category NDA
Marketing start 2023-09-15
Substance MOMELOTINIB DIHYDROCHLORIDE MONOHYDRATE
Active strength 200 mg/1
Pharmacologic classes Breast Cancer Resistance Protein Inhibitors [MoA], Kinase Inhibitor [EPC], Kinase 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 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N216873-001 OJJAARA MOMELOTINIB DIHYDROCHLORIDE EQ 100MG BASE TABLET / ORAL RLD 2023-09-15 N216873-002 OJJAARA MOMELOTINIB DIHYDROCHLORIDE EQ 150MG BASE TABLET / ORAL RLD 2023-09-15 N216873-003 OJJAARA MOMELOTINIB DIHYDROCHLORIDE EQ 200MG BASE TABLET / ORAL RLD, RS 2023-09-15
Orange Book patents# Current patent rows page 1 of 1 · 15 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N216873-001 8486941 2035-01-03 U-1201 Drug substance, Drug product 2023-10-04 N216873-001 9809559 2035-06-11 U-1201 2023-10-04 N216873-001 RE48285 2035-06-11 U-1201 Drug substance, Drug product 2023-10-04 N216873-001 12576089 2039-08-21 U-4441 2026-03-27 N216873-001 11963962 2040-12-02 U-3928 2024-05-21 N216873-002 8486941 2035-01-03 U-1201 Drug substance, Drug product 2023-10-04 N216873-002 9809559 2035-06-11 U-1201 2023-10-04 N216873-002 RE48285 2035-06-11 U-1201 Drug substance, Drug product 2023-10-04 N216873-002 12576089 2039-08-21 U-4441 2026-03-27 N216873-002 11963962 2040-12-02 U-3928 2024-05-21 N216873-003 8486941 2035-01-03 U-1201 Drug substance, Drug product 2023-10-04 N216873-003 9809559 2035-06-11 U-1201 2023-10-04 N216873-003 RE48285 2035-06-11 U-1201 Drug substance, Drug product 2023-10-04 N216873-003 12576089 2039-08-21 U-4441 2026-03-27 N216873-003 11963962 2040-12-02 U-3928 2024-05-21
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.
Product history page 1 of 2 · 66 observed 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 N216873-001 OJJAARA EQ 100MG BASE TABLET / ORAL RLD 2023-09-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216873-002 OJJAARA EQ 150MG BASE TABLET / ORAL RLD 2023-09-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216873-003 OJJAARA EQ 200MG BASE TABLET / ORAL RLD, RS 2023-09-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216873-001 OJJAARA EQ 100MG BASE TABLET / ORAL RLD 2023-09-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216873-002 OJJAARA EQ 150MG BASE TABLET / ORAL RLD 2023-09-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216873-003 OJJAARA EQ 200MG BASE TABLET / ORAL RLD, RS 2023-09-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216873-001 OJJAARA EQ 100MG BASE TABLET / ORAL RLD 2023-09-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216873-002 OJJAARA EQ 150MG BASE TABLET / ORAL RLD 2023-09-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216873-003 OJJAARA EQ 200MG BASE TABLET / ORAL RLD, RS 2023-09-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216873-001 OJJAARA EQ 100MG BASE TABLET / ORAL RLD 2023-09-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216873-002 OJJAARA EQ 150MG BASE TABLET / ORAL RLD 2023-09-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216873-003 OJJAARA EQ 200MG BASE TABLET / ORAL RLD, RS 2023-09-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216873-001 OJJAARA EQ 100MG BASE TABLET / ORAL RLD 2023-09-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216873-002 OJJAARA EQ 150MG BASE TABLET / ORAL RLD 2023-09-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216873-003 OJJAARA EQ 200MG BASE TABLET / ORAL RLD, RS 2023-09-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216873-001 OJJAARA EQ 100MG BASE TABLET / ORAL RLD 2023-09-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216873-002 OJJAARA EQ 150MG BASE TABLET / ORAL RLD 2023-09-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216873-003 OJJAARA EQ 200MG BASE TABLET / ORAL RLD, RS 2023-09-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216873-001 OJJAARA EQ 100MG BASE TABLET / ORAL RLD 2023-09-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216873-002 OJJAARA EQ 150MG BASE TABLET / ORAL RLD 2023-09-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216873-003 OJJAARA EQ 200MG BASE TABLET / ORAL RLD, RS 2023-09-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216873-001 OJJAARA EQ 100MG BASE TABLET / ORAL RLD 2023-09-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216873-002 OJJAARA EQ 150MG BASE TABLET / ORAL RLD 2023-09-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216873-003 OJJAARA EQ 200MG BASE TABLET / ORAL RLD, RS 2023-09-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216873-001 OJJAARA EQ 100MG BASE TABLET / ORAL RLD 2023-09-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216873-002 OJJAARA EQ 150MG BASE TABLET / ORAL RLD 2023-09-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216873-003 OJJAARA EQ 200MG BASE TABLET / ORAL RLD, RS 2023-09-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216873-001 OJJAARA EQ 100MG BASE TABLET / ORAL RLD 2023-09-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216873-002 OJJAARA EQ 150MG BASE TABLET / ORAL RLD 2023-09-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216873-003 OJJAARA EQ 200MG BASE TABLET / ORAL RLD, RS 2023-09-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216873-001 OJJAARA EQ 100MG BASE TABLET / ORAL RLD 2023-09-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216873-002 OJJAARA EQ 150MG BASE TABLET / ORAL RLD 2023-09-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216873-003 OJJAARA EQ 200MG BASE TABLET / ORAL RLD, RS 2023-09-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216873-001 OJJAARA EQ 100MG BASE TABLET / ORAL RLD 2023-09-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N216873-002 OJJAARA EQ 150MG BASE TABLET / ORAL RLD 2023-09-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N216873-003 OJJAARA EQ 200MG BASE TABLET / ORAL RLD, RS 2023-09-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216873-001 OJJAARA EQ 100MG BASE TABLET / ORAL RLD 2023-09-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216873-002 OJJAARA EQ 150MG BASE TABLET / ORAL RLD 2023-09-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216873-003 OJJAARA EQ 200MG BASE TABLET / ORAL RLD, RS 2023-09-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216873-001 OJJAARA EQ 100MG BASE TABLET / ORAL RLD 2023-09-15 301d65b070ca…
Observed Orange Book patent history# Patent history page 1 of 7 · 255 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 N216873-001 8486941 2035-01-03 U-1201 Drug substance, Drug product 2023-10-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216873-001 9809559 2035-06-11 U-1201 2023-10-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216873-001 RE48285 2035-06-11 U-1201 Drug substance, Drug product 2023-10-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216873-001 12576089 2039-08-21 U-4441 2026-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216873-001 11963962 2040-12-02 U-3928 2024-05-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216873-002 8486941 2035-01-03 U-1201 Drug substance, Drug product 2023-10-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216873-002 9809559 2035-06-11 U-1201 2023-10-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216873-002 RE48285 2035-06-11 U-1201 Drug substance, Drug product 2023-10-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216873-002 12576089 2039-08-21 U-4441 2026-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216873-002 11963962 2040-12-02 U-3928 2024-05-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216873-003 8486941 2035-01-03 U-1201 Drug substance, Drug product 2023-10-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216873-003 9809559 2035-06-11 U-1201 2023-10-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216873-003 RE48285 2035-06-11 U-1201 Drug substance, Drug product 2023-10-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216873-003 12576089 2039-08-21 U-4441 2026-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216873-003 11963962 2040-12-02 U-3928 2024-05-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216873-001 8486941 2035-01-03 U-1201 Drug substance, Drug product 2023-10-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216873-001 9809559 2035-06-11 U-1201 2023-10-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216873-001 RE48285 2035-06-11 U-1201 Drug substance, Drug product 2023-10-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216873-001 12576089 2039-08-21 U-4441 2026-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216873-001 11963962 2040-12-02 U-3928 2024-05-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216873-002 8486941 2035-01-03 U-1201 Drug substance, Drug product 2023-10-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216873-002 9809559 2035-06-11 U-1201 2023-10-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216873-002 RE48285 2035-06-11 U-1201 Drug substance, Drug product 2023-10-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216873-002 12576089 2039-08-21 U-4441 2026-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216873-002 11963962 2040-12-02 U-3928 2024-05-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216873-003 8486941 2035-01-03 U-1201 Drug substance, Drug product 2023-10-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216873-003 9809559 2035-06-11 U-1201 2023-10-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216873-003 RE48285 2035-06-11 U-1201 Drug substance, Drug product 2023-10-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216873-003 12576089 2039-08-21 U-4441 2026-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216873-003 11963962 2040-12-02 U-3928 2024-05-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216873-001 8486941 2030-01-03 U-1201 Drug substance, Drug product 2023-10-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216873-001 9809559 2035-06-11 U-1201 2023-10-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216873-001 RE48285 2035-06-11 U-1201 Drug substance, Drug product 2023-10-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216873-001 11963962 2040-12-02 U-3928 2024-05-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216873-002 8486941 2030-01-03 U-1201 Drug substance, Drug product 2023-10-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216873-002 9809559 2035-06-11 U-1201 2023-10-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216873-002 RE48285 2035-06-11 U-1201 Drug substance, Drug product 2023-10-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216873-002 11963962 2040-12-02 U-3928 2024-05-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216873-003 8486941 2030-01-03 U-1201 Drug substance, Drug product 2023-10-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216873-003 9809559 2035-06-11 U-1201 2023-10-04 011fe1cb6892…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 132 observed states.
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 Ojjaara
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MOMELOTINIB DIHYDROCHLORIDE MONOHYDRATE 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination LDX8893L5D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2665210 Internal RxNorm lookup 2665216 Internal RxNorm lookup 2665218 Internal RxNorm lookup 2665220 Internal RxNorm lookup 2665222 Internal RxNorm lookup 2665224 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 81864-101-30 Ojjaara 30 in 1 BOTTLE TABLET 30 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81864-101 OJJAARA (MOMELOTINIB) TABLET [GLAXOSMITHKLINE LLC] 6 Current NDC, 1 package rows 20250430_4a672fd1-eb7b-4aa9-9b23-845e4b5dc400.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 81864-101-30 81864010130 30 TABLET in 1 BOTTLE (81864-101-30) 30 tablet 2023-09-15 No No Current