Ojjaara

Product NDC: 81864-102
11-digit product format: 818640102
Labeler code: 81864
Product ID: 81864-102_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: 150 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	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.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N216873-001	NCE	2028-09-15
N216873-001	ODE-441	2030-09-15
N216873-002	NCE	2028-09-15
N216873-002	ODE-441	2030-09-15
N216873-003	NCE	2028-09-15
N216873-003	ODE-441	2030-09-15

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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N216873-001	NCE	2028-09-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216873-001	ODE-441	2030-09-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216873-002	NCE	2028-09-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216873-002	ODE-441	2030-09-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216873-003	NCE	2028-09-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216873-003	ODE-441	2030-09-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216873-001	NCE	2028-09-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216873-001	ODE-441	2030-09-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216873-002	NCE	2028-09-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216873-002	ODE-441	2030-09-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216873-003	NCE	2028-09-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216873-003	ODE-441	2030-09-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216873-001	NCE	2028-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216873-001	ODE-441	2030-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216873-002	NCE	2028-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216873-002	ODE-441	2030-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216873-003	NCE	2028-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216873-003	ODE-441	2030-09-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216873-001	NCE	2028-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216873-001	ODE-441	2030-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216873-002	NCE	2028-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216873-002	ODE-441	2030-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216873-003	NCE	2028-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216873-003	ODE-441	2030-09-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216873-001	NCE	2028-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216873-001	ODE-441	2030-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216873-002	NCE	2028-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216873-002	ODE-441	2030-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216873-003	NCE	2028-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216873-003	ODE-441	2030-09-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216873-001	NCE	2028-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216873-001	ODE-441	2030-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216873-002	NCE	2028-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216873-002	ODE-441	2030-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216873-003	NCE	2028-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216873-003	ODE-441	2030-09-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216873-001	NCE	2028-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216873-001	ODE-441	2030-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216873-002	NCE	2028-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216873-002	ODE-441	2030-09-15	`b8a1b40f171c…`

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	150 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4a672fd1-eb7b-4aa9-9b23-845e4b5dc400	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
231b345c-e8f7-4afa-9c0d-901845058cbd	Product name	1	20230919

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
81864-102-30	Ojjaara	30 in 1 BOTTLE	TABLET	30		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
81864-102-30	EA - Each	81864-102	cc5c226c-92b9-4575-aac7-b3c32454383b	1	2023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81864-102	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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ojjaara	MOMELOTINIB	GlaxoSmithKline LLC	4a672fd1-eb7b-4aa9-9b23-845e4b5dc400	2026-07-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 216873 application number: NDA216873 ndc (product): 81864-102

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6O01GMS00P	MOMELOTINIB	1056634-68-4	Momelotinib

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2665210	momelotinib 100 MG Oral Tablet	PSN	4a672fd1-eb7b-4aa9-9b23-845e4b5dc400	8
2665218	momelotinib 150 MG Oral Tablet	PSN	4a672fd1-eb7b-4aa9-9b23-845e4b5dc400	8
2665222	momelotinib 200 MG Oral Tablet	PSN	4a672fd1-eb7b-4aa9-9b23-845e4b5dc400	8
2665216	Ojjaara 100 MG Oral Tablet	PSN	4a672fd1-eb7b-4aa9-9b23-845e4b5dc400	8
2665220	Ojjaara 150 MG Oral Tablet	PSN	4a672fd1-eb7b-4aa9-9b23-845e4b5dc400	8
2665224	Ojjaara 200 MG Oral Tablet	PSN	4a672fd1-eb7b-4aa9-9b23-845e4b5dc400	8
2665216	momelotinib 100 MG Oral Tablet [Ojjaara]	SBD	4a672fd1-eb7b-4aa9-9b23-845e4b5dc400	8
2665220	momelotinib 150 MG Oral Tablet [Ojjaara]	SBD	4a672fd1-eb7b-4aa9-9b23-845e4b5dc400	8
2665224	momelotinib 200 MG Oral Tablet [Ojjaara]	SBD	4a672fd1-eb7b-4aa9-9b23-845e4b5dc400	8
2665210	momelotinib 100 MG Oral Tablet	SCD	4a672fd1-eb7b-4aa9-9b23-845e4b5dc400	8
2665218	momelotinib 150 MG Oral Tablet	SCD	4a672fd1-eb7b-4aa9-9b23-845e4b5dc400	8
2665222	momelotinib 200 MG Oral Tablet	SCD	4a672fd1-eb7b-4aa9-9b23-845e4b5dc400	8
2665210	momelotinib 100 MG (equivalent to 121.94 MG momelotinib dihydrochloride monohydrate) Oral Tablet	SY	4a672fd1-eb7b-4aa9-9b23-845e4b5dc400	8
2665218	momelotinib 150 MG (equivalent to 182.91 MG momelotinib dihydrochloride monohydrate) Oral Tablet	SY	4a672fd1-eb7b-4aa9-9b23-845e4b5dc400	8
2665222	momelotinib 200 MG (equivalent to 243.88 MG momelotinib dihydrochloride monohydrate) Oral Tablet	SY	4a672fd1-eb7b-4aa9-9b23-845e4b5dc400	8
2665216	Ojjaara 100 MG (equivalent to 121.94 MG momelotinib dihydrochloride monohydrate) Oral Tablet	SY	4a672fd1-eb7b-4aa9-9b23-845e4b5dc400	8
2665220	Ojjaara 150 MG (equivalent to 182.91 MG momelotinib dihydrochloride monohydrate) Oral Tablet	SY	4a672fd1-eb7b-4aa9-9b23-845e4b5dc400	8
2665224	Ojjaara 200 MG (equivalent to 243.88 MG momelotinib dihydrochloride monohydrate) Oral Tablet	SY	4a672fd1-eb7b-4aa9-9b23-845e4b5dc400	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
81864-102-30	81864010230	30 TABLET in 1 BOTTLE (81864-102-30)	30 tablet	2023-09-15	No	No	Current