JORNAY PM

Product NDC: 71376-201
11-digit product format: 713760201
Labeler code: 71376
Product ID: 71376-201_1c0e3d41-30b4-4815-8dbc-5466eaf56f8f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methylphenidate Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Ironshore Pharmaceuticals Inc.
Application: NDA209311
Marketing category: NDA
Marketing start: 2019-06-01
Substance: METHYLPHENIDATE HYDROCHLORIDE
Active strength: 20 mg/1
Pharmacologic classes: Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule: CII
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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N209311-001	JORNAY PM	METHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08
N209311-002	JORNAY PM	METHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08
N209311-003	JORNAY PM	METHYLPHENIDATE HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08
N209311-004	JORNAY PM	METHYLPHENIDATE HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08
N209311-005	JORNAY PM	METHYLPHENIDATE HYDROCHLORIDE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2018-08-08

Orange Book patents#

Current patent rows page 1 of 1 · 80 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209311-001	10182995	2032-03-23		Drug product	2019-02-05
N209311-001	10292937	2032-03-23	U-2357		2019-06-20
N209311-001	10617651	2032-03-23	U-2357		2020-04-30
N209311-001	10881618	2032-03-23	U-2357		2021-02-24
N209311-001	10905652	2032-03-23		Drug product	2021-02-24
N209311-001	11241391	2032-03-23	U-2357		2022-03-10
N209311-001	11241392	2032-03-23		Drug product	2022-03-10
N209311-001	11911518	2032-03-23	U-2357		2024-03-20
N209311-001	8916588	2032-03-23	U-2357		2018-09-13
N209311-001	8927010	2032-03-23		Drug product	2018-09-07
N209311-001	9023389	2032-03-23		Drug product	2018-09-07
N209311-001	9028868	2032-03-23	U-2357		2018-09-13
N209311-001	9034902	2032-03-23	U-2357		2018-09-13
N209311-001	9283214	2032-03-23		Drug product	2018-09-07
N209311-001	9498447	2032-03-23		Drug product	2018-09-07
N209311-001	9603809	2032-03-23	U-2357		2018-09-13
N209311-002	10182995	2032-03-23		Drug product	2019-02-05
N209311-002	10292937	2032-03-23	U-2357		2019-06-20
N209311-002	10617651	2032-03-23	U-2357		2020-04-30
N209311-002	10881618	2032-03-23	U-2357		2021-02-24
N209311-002	10905652	2032-03-23		Drug product	2021-02-24
N209311-002	11241391	2032-03-23	U-2357		2022-03-10
N209311-002	11241392	2032-03-23		Drug product	2022-03-10
N209311-002	11911518	2032-03-23	U-2357		2024-03-20
N209311-002	8916588	2032-03-23	U-2357		2018-09-13
N209311-002	8927010	2032-03-23		Drug product	2018-09-07
N209311-002	9023389	2032-03-23		Drug product	2018-09-07
N209311-002	9028868	2032-03-23	U-2357		2018-09-13
N209311-002	9034902	2032-03-23	U-2357		2018-09-13
N209311-002	9283214	2032-03-23		Drug product	2018-09-07
N209311-002	9498447	2032-03-23		Drug product	2018-09-07
N209311-002	9603809	2032-03-23	U-2357		2018-09-13
N209311-003	10182995	2032-03-23		Drug product	2019-02-05
N209311-003	10292937	2032-03-23	U-2357		2019-06-20
N209311-003	10617651	2032-03-23	U-2357		2020-04-30
N209311-003	10881618	2032-03-23	U-2357		2021-02-24
N209311-003	10905652	2032-03-23		Drug product	2021-02-24
N209311-003	11241391	2032-03-23	U-2357		2022-03-10
N209311-003	11241392	2032-03-23		Drug product	2022-03-10
N209311-003	11911518	2032-03-23	U-2357		2024-03-20
N209311-003	8916588	2032-03-23	U-2357		2018-09-13
N209311-003	8927010	2032-03-23		Drug product	2018-09-07
N209311-003	9023389	2032-03-23		Drug product	2018-09-07
N209311-003	9028868	2032-03-23	U-2357		2018-09-13
N209311-003	9034902	2032-03-23	U-2357		2018-09-13
N209311-003	9283214	2032-03-23		Drug product	2018-09-07
N209311-003	9498447	2032-03-23		Drug product	2018-09-07
N209311-003	9603809	2032-03-23	U-2357		2018-09-13
N209311-004	10182995	2032-03-23		Drug product	2019-02-05
N209311-004	10292937	2032-03-23	U-2357		2019-06-20
N209311-004	10617651	2032-03-23	U-2357		2020-04-30
N209311-004	10881618	2032-03-23	U-2357		2021-02-24
N209311-004	10905652	2032-03-23		Drug product	2021-02-24
N209311-004	11241391	2032-03-23	U-2357		2022-03-10
N209311-004	11241392	2032-03-23		Drug product	2022-03-10
N209311-004	11911518	2032-03-23	U-2357		2024-03-20
N209311-004	8916588	2032-03-23	U-2357		2018-09-13
N209311-004	8927010	2032-03-23		Drug product	2018-09-07
N209311-004	9023389	2032-03-23		Drug product	2018-09-07
N209311-004	9028868	2032-03-23	U-2357		2018-09-13
N209311-004	9034902	2032-03-23	U-2357		2018-09-13
N209311-004	9283214	2032-03-23		Drug product	2018-09-07
N209311-004	9498447	2032-03-23		Drug product	2018-09-07
N209311-004	9603809	2032-03-23	U-2357		2018-09-13
N209311-005	10182995	2032-03-23		Drug product	2019-02-05
N209311-005	10292937	2032-03-23	U-2357		2019-06-20
N209311-005	10617651	2032-03-23	U-2357		2020-04-30
N209311-005	10881618	2032-03-23	U-2357		2021-02-24
N209311-005	10905652	2032-03-23		Drug product	2021-02-24
N209311-005	11241391	2032-03-23	U-2357		2022-03-10
N209311-005	11241392	2032-03-23		Drug product	2022-03-10
N209311-005	11911518	2032-03-23	U-2357		2024-03-20
N209311-005	8916588	2032-03-23	U-2357		2018-09-13
N209311-005	8927010	2032-03-23		Drug product	2018-09-07
N209311-005	9023389	2032-03-23		Drug product	2018-09-07
N209311-005	9028868	2032-03-23	U-2357		2018-09-13
N209311-005	9034902	2032-03-23	U-2357		2018-09-13
N209311-005	9283214	2032-03-23		Drug product	2018-09-07
N209311-005	9498447	2032-03-23		Drug product	2018-09-07
N209311-005	9603809	2032-03-23	U-2357		2018-09-13

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 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209311-001	JORNAY PM	20MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-002	JORNAY PM	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-003	JORNAY PM	60MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-004	JORNAY PM	80MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-005	JORNAY PM	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2018-08-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209311-001	JORNAY PM	20MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209311-002	JORNAY PM	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209311-003	JORNAY PM	60MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209311-004	JORNAY PM	80MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209311-005	JORNAY PM	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2018-08-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209311-001	JORNAY PM	20MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209311-002	JORNAY PM	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209311-003	JORNAY PM	60MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209311-004	JORNAY PM	80MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209311-005	JORNAY PM	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2018-08-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209311-001	JORNAY PM	20MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209311-002	JORNAY PM	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209311-003	JORNAY PM	60MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209311-004	JORNAY PM	80MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209311-005	JORNAY PM	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2018-08-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209311-001	JORNAY PM	20MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209311-002	JORNAY PM	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209311-003	JORNAY PM	60MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209311-004	JORNAY PM	80MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209311-005	JORNAY PM	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2018-08-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209311-001	JORNAY PM	20MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209311-002	JORNAY PM	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209311-003	JORNAY PM	60MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209311-004	JORNAY PM	80MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209311-005	JORNAY PM	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2018-08-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209311-001	JORNAY PM	20MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209311-002	JORNAY PM	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209311-003	JORNAY PM	60MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209311-004	JORNAY PM	80MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209311-005	JORNAY PM	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2018-08-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209311-001	JORNAY PM	20MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209311-002	JORNAY PM	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209311-003	JORNAY PM	60MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209311-004	JORNAY PM	80MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209311-005	JORNAY PM	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2018-08-08	`5bbf6a4d5a75…`

Observed Orange Book patent history#

Patent history page 1 of 74 · 2,960 observed states.

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	N209311-001	10182995	2032-03-23		Drug product	2019-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-001	10292937	2032-03-23	U-2357		2019-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-001	10617651	2032-03-23	U-2357		2020-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-001	10881618	2032-03-23	U-2357		2021-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-001	10905652	2032-03-23		Drug product	2021-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-001	11241391	2032-03-23	U-2357		2022-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-001	11241392	2032-03-23		Drug product	2022-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-001	11911518	2032-03-23	U-2357		2024-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-001	8916588	2032-03-23	U-2357		2018-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-001	8927010	2032-03-23		Drug product	2018-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-001	9023389	2032-03-23		Drug product	2018-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-001	9028868	2032-03-23	U-2357		2018-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-001	9034902	2032-03-23	U-2357		2018-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-001	9283214	2032-03-23		Drug product	2018-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-001	9498447	2032-03-23		Drug product	2018-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-001	9603809	2032-03-23	U-2357		2018-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-002	10182995	2032-03-23		Drug product	2019-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-002	10292937	2032-03-23	U-2357		2019-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-002	10617651	2032-03-23	U-2357		2020-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-002	10881618	2032-03-23	U-2357		2021-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-002	10905652	2032-03-23		Drug product	2021-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-002	11241391	2032-03-23	U-2357		2022-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-002	11241392	2032-03-23		Drug product	2022-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-002	11911518	2032-03-23	U-2357		2024-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-002	8916588	2032-03-23	U-2357		2018-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-002	8927010	2032-03-23		Drug product	2018-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-002	9023389	2032-03-23		Drug product	2018-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-002	9028868	2032-03-23	U-2357		2018-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-002	9034902	2032-03-23	U-2357		2018-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-002	9283214	2032-03-23		Drug product	2018-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-002	9498447	2032-03-23		Drug product	2018-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-002	9603809	2032-03-23	U-2357		2018-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-003	10182995	2032-03-23		Drug product	2019-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-003	10292937	2032-03-23	U-2357		2019-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-003	10617651	2032-03-23	U-2357		2020-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-003	10881618	2032-03-23	U-2357		2021-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-003	10905652	2032-03-23		Drug product	2021-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-003	11241391	2032-03-23	U-2357		2022-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-003	11241392	2032-03-23		Drug product	2022-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-003	11911518	2032-03-23	U-2357		2024-03-20	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 45 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N209311-001	NP	2021-08-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209311-002	NP	2021-08-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209311-003	NP	2021-08-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209311-004	NP	2021-08-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209311-005	NP	2021-08-08	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N209311-001	NP	2021-08-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209311-002	NP	2021-08-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209311-003	NP	2021-08-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209311-004	NP	2021-08-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209311-005	NP	2021-08-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209311-001	NP	2021-08-08	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209311-002	NP	2021-08-08	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209311-003	NP	2021-08-08	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209311-004	NP	2021-08-08	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209311-005	NP	2021-08-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209311-001	NP	2021-08-08	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N209311-002	NP	2021-08-08	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N209311-003	NP	2021-08-08	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N209311-004	NP	2021-08-08	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N209311-005	NP	2021-08-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209311-001	NP	2021-08-08	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209311-002	NP	2021-08-08	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209311-003	NP	2021-08-08	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209311-004	NP	2021-08-08	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209311-005	NP	2021-08-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209311-001	NP	2021-08-08	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N209311-002	NP	2021-08-08	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N209311-003	NP	2021-08-08	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N209311-004	NP	2021-08-08	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N209311-005	NP	2021-08-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209311-001	NP	2021-08-08	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209311-002	NP	2021-08-08	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209311-003	NP	2021-08-08	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209311-004	NP	2021-08-08	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209311-005	NP	2021-08-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209311-001	NP	2021-08-08	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209311-002	NP	2021-08-08	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209311-003	NP	2021-08-08	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209311-004	NP	2021-08-08	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209311-005	NP	2021-08-08	`b00525d2431f…`

Additional Listing Data#

Finished product: Yes
Brand name base: JORNAY PM
Brand name suffix: Extended-Release
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHYLPHENIDATE HYDROCHLORIDE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4B3SC438HI	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2168857	Internal RxNorm lookup
2168859	Internal RxNorm lookup
2168861	Internal RxNorm lookup
2168863	Internal RxNorm lookup
2168864	Internal RxNorm lookup
2168865	Internal RxNorm lookup
2168866	Internal RxNorm lookup
2168867	Internal RxNorm lookup
2168868	Internal RxNorm lookup
2168869	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
d95dede0-b1ff-4489-8f91-3bbe122852bf	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
143536be-f21a-464c-bc5a-163f5c171815	Product name	2	20250626
fd4d0878-dcea-3832-288e-e3bbbbe580ff	Product name	9	20240516
435f0341-cf24-41d5-8fbf-c909821e5596	Product name	1	20230313
c9b6eabb-08d7-bb2d-e81a-06be3590b436	Product name	2	20221216
67aa32c6-44f4-50de-64dd-643e8caf420d	Product name	6	20210622
50b24f34-96fa-4f1e-b262-b0baf4a4a440	Product name	4	20210513
cf83c421-eebe-4de2-b1a2-fd96e3dbfcf8	Product name	1	20200128
166d1d2d-dd55-4fdf-82e2-b83a3c5347c1	Product name	1	20190828
343a61d5-785d-cc27-a43a-0779da054d88	Product name	3	20190828
7607489b-cd15-3103-f3b1-d4283574d250	Product name	2	20190614
407f0cce-da29-4050-a512-2cabe9e5692d	Product name	9	20190611
f7f4bf1e-7c67-46c6-8c42-9beb1a06b38e	Product name	2	20190415
190572d9-6c7b-4b40-8172-c1b5f802c20f	Product name	1	20180724
2948856e-f76e-d380-d9ed-b317efafbc98	Product name	5	20180423
c0aa09de-7aa1-4a98-8f70-62ec3c97c695	Product name	1	20170803
3317aade-2d6e-f159-9fe6-e8385a825178	Product name	3	20160829
0fe52203-83a7-4fed-a91f-8e47a22cf1d3	Product name	1	20160111

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-08-23	These highlights do not include all the information needed to use JORNAY PM® safely and effectively. See full prescribing information for JORNAY PM. JORNAY PM (methylphenidate hydrochloride) extended-release capsules, for oral use, CII Initial U.S. Approval: 1955
2024-08-23	These highlights do not include all the information needed to use JORNAY PM® safely and effectively. See full prescribing information for JORNAY PM. JORNAY PM (methylphenidate hydrochloride) extended-release capsules, for oral use, CII Initial U.S. Approval: 1955
2024-07-30	These highlights do not include all the information needed to use JORNAY PM® safely and effectively. See full prescribing information for JORNAY PM. JORNAY PM (methylphenidate hydrochloride) extended-release capsules, for oral use, CII Initial U.S. Approval: 1955
2024-07-30	These highlights do not include all the information needed to use JORNAY PM® safely and effectively. See full prescribing information for JORNAY PM. JORNAY PM (methylphenidate hydrochloride) extended-release capsules, for oral use, CII Initial U.S. Approval: 1955
2024-01-30	These highlights do not include all the information needed to use JORNAY PM® safely and effectively. See full prescribing information for JORNAY PM. JORNAY PM (methylphenidate hydrochloride) extended-release capsules, for oral use, CII Initial U.S. Approval: 1955
2024-01-30	These highlights do not include all the information needed to use JORNAY PM® safely and effectively. See full prescribing information for JORNAY PM. JORNAY PM (methylphenidate hydrochloride) extended-release capsules, for oral use, CII Initial U.S. Approval: 1955

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71376-201-03	JORNAY PM Extended-Release	100 in 1 BOTTLE	CAPSULE	100		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71376-201-03	EA - Each	71376-201	5ce2db17-daf9-4329-a38c-d6427ba114ef	1	2019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71376-201	JORNAY PM EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [IRONSHORE PHARMACEUTICALS INC.]	15	Current NDC, Legacy NDC, 1 package rows	20240824_d95dede0-b1ff-4489-8f91-3bbe122852bf.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
JORNAY PM Extended-Release	METHYLPHENIDATE HYDROCHLORIDE	Ironshore Pharmaceuticals Inc.	d95dede0-b1ff-4489-8f91-3bbe122852bf	2025-10-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 209311 application number: NDA209311 ndc (product): 71376-201

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4B3SC438HI	METHYLPHENIDATE HYDROCHLORIDE	23655-65-4	METHYLPHENIDATE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2168865	JORNAY PM 100 MG 24HR Extended Release Oral Capsule	PSN	d95dede0-b1ff-4489-8f91-3bbe122852bf	16
2168867	JORNAY PM 20 MG 24HR Extended Release Oral Capsule	PSN	d95dede0-b1ff-4489-8f91-3bbe122852bf	16
2168869	JORNAY PM 40 MG 24HR Extended Release Oral Capsule	PSN	d95dede0-b1ff-4489-8f91-3bbe122852bf	16
2168859	JORNAY PM 60 MG 24HR Extended Release Oral Capsule	PSN	d95dede0-b1ff-4489-8f91-3bbe122852bf	16
2168863	JORNAY PM 80 MG 24HR Extended Release Oral Capsule	PSN	d95dede0-b1ff-4489-8f91-3bbe122852bf	16
2168864	methylphenidate HCl 100 MG 24HR Extended Release Oral Capsule, Evening Dosing	PSN	d95dede0-b1ff-4489-8f91-3bbe122852bf	16
2168866	methylphenidate HCl 20 MG 24HR Extended Release Oral Capsule, Evening Dosing	PSN	d95dede0-b1ff-4489-8f91-3bbe122852bf	16
2168868	methylphenidate HCl 40 MG 24HR Extended Release Oral Capsule, Evening Dosing	PSN	d95dede0-b1ff-4489-8f91-3bbe122852bf	16
2168857	methylphenidate HCl 60 MG 24HR Extended Release Oral Capsule, Evening Dosing	PSN	d95dede0-b1ff-4489-8f91-3bbe122852bf	16
2168861	methylphenidate HCl 80 MG 24HR Extended Release Oral Capsule, Evening Dosing	PSN	d95dede0-b1ff-4489-8f91-3bbe122852bf	16
2168865	Evening Dosing 24 HR methylphenidate hydrochloride 100 MG Extended Release Oral Capsule [Jornay]	SBD	d95dede0-b1ff-4489-8f91-3bbe122852bf	16
2168867	Evening Dosing 24 HR methylphenidate hydrochloride 20 MG Extended Release Oral Capsule [Jornay]	SBD	d95dede0-b1ff-4489-8f91-3bbe122852bf	16
2168869	Evening Dosing 24 HR methylphenidate hydrochloride 40 MG Extended Release Oral Capsule [Jornay]	SBD	d95dede0-b1ff-4489-8f91-3bbe122852bf	16
2168859	Evening Dosing 24 HR methylphenidate hydrochloride 60 MG Extended Release Oral Capsule [Jornay]	SBD	d95dede0-b1ff-4489-8f91-3bbe122852bf	16
2168863	Evening Dosing 24 HR methylphenidate hydrochloride 80 MG Extended Release Oral Capsule [Jornay]	SBD	d95dede0-b1ff-4489-8f91-3bbe122852bf	16
2168864	Evening Dosing 24 HR methylphenidate hydrochloride 100 MG Extended Release Oral Capsule	SCD	d95dede0-b1ff-4489-8f91-3bbe122852bf	16
2168866	Evening Dosing 24 HR methylphenidate hydrochloride 20 MG Extended Release Oral Capsule	SCD	d95dede0-b1ff-4489-8f91-3bbe122852bf	16
2168868	Evening Dosing 24 HR methylphenidate hydrochloride 40 MG Extended Release Oral Capsule	SCD	d95dede0-b1ff-4489-8f91-3bbe122852bf	16
2168857	Evening Dosing 24 HR methylphenidate hydrochloride 60 MG Extended Release Oral Capsule	SCD	d95dede0-b1ff-4489-8f91-3bbe122852bf	16
2168861	Evening Dosing 24 HR methylphenidate hydrochloride 80 MG Extended Release Oral Capsule	SCD	d95dede0-b1ff-4489-8f91-3bbe122852bf	16
2168865	Evening Dosing 24 HR Jornay 100 MG Extended Release Oral Capsule	SY	d95dede0-b1ff-4489-8f91-3bbe122852bf	16
2168867	Evening Dosing 24 HR Jornay 20 MG Extended Release Oral Capsule	SY	d95dede0-b1ff-4489-8f91-3bbe122852bf	16
2168869	Evening Dosing 24 HR Jornay 40 MG Extended Release Oral Capsule	SY	d95dede0-b1ff-4489-8f91-3bbe122852bf	16
2168859	Evening Dosing 24 HR Jornay 60 MG Extended Release Oral Capsule	SY	d95dede0-b1ff-4489-8f91-3bbe122852bf	16
2168863	Evening Dosing 24 HR Jornay 80 MG Extended Release Oral Capsule	SY	d95dede0-b1ff-4489-8f91-3bbe122852bf	16
2168865	Jornay PM 100 MG 24HR Extended Release Oral Capsule	SY	d95dede0-b1ff-4489-8f91-3bbe122852bf	16
2168867	Jornay PM 20 MG 24HR Extended Release Oral Capsule	SY	d95dede0-b1ff-4489-8f91-3bbe122852bf	16
2168869	Jornay PM 40 MG 24HR Extended Release Oral Capsule	SY	d95dede0-b1ff-4489-8f91-3bbe122852bf	16
2168859	Jornay PM 60 MG 24HR Extended Release Oral Capsule	SY	d95dede0-b1ff-4489-8f91-3bbe122852bf	16
2168863	Jornay PM 80 MG 24HR Extended Release Oral Capsule	SY	d95dede0-b1ff-4489-8f91-3bbe122852bf	16
2168864	methylphenidate HCl 100 MG 24HR Extended Release Oral Capsule, Evening Dosing	SY	d95dede0-b1ff-4489-8f91-3bbe122852bf	16
2168866	methylphenidate HCl 20 MG 24HR Extended Release Oral Capsule, Evening Dosing	SY	d95dede0-b1ff-4489-8f91-3bbe122852bf	16
2168868	methylphenidate HCl 40 MG 24HR Extended Release Oral Capsule, Evening Dosing	SY	d95dede0-b1ff-4489-8f91-3bbe122852bf	16
2168857	methylphenidate HCl 60 MG 24HR Extended Release Oral Capsule, Evening Dosing	SY	d95dede0-b1ff-4489-8f91-3bbe122852bf	16
2168861	methylphenidate HCl 80 MG 24HR Extended Release Oral Capsule, Evening Dosing	SY	d95dede0-b1ff-4489-8f91-3bbe122852bf	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71376-201-03	71376020103	100 CAPSULE in 1 BOTTLE (71376-201-03)	100 capsule	2019-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
JORNAY PM Extended-Release	Ironshore Pharmaceuticals Inc. \| Patheon Puerto Rico, Inc.	2025-10-03	HUMAN PRESCRIPTION DRUG LABEL	16