RELEXXII

Product NDC: 68025-084
11-digit product format: 680250084
Labeler code: 68025
Product ID: 68025-084_86f477e9-07fc-466b-913e-1a4434c91df4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methylphenidate hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Vertical Pharmaceuticals, LLC
Application: NDA216117
Marketing category: NDA
Marketing start: 2022-06-23
Substance: METHYLPHENIDATE HYDROCHLORIDE
Active strength: 72 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 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N216117-001	RELEXXII	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-06-23
N216117-002	RELEXXII	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-06-23
N216117-003	RELEXXII	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-06-23
N216117-004	RELEXXII	METHYLPHENIDATE HYDROCHLORIDE	45MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-06-23
N216117-005	RELEXXII	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-06-23
N216117-006	RELEXXII	METHYLPHENIDATE HYDROCHLORIDE	63MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-06-23
N216117-007	RELEXXII	METHYLPHENIDATE HYDROCHLORIDE	72MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-06-23

Orange Book patents#

Current patent rows page 1 of 1 · 35 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N216117-001	10265308	2037-02-03	U-4032	Drug product	2024-11-18
N216117-001	10695336	2037-02-03	U-4032		2024-11-18
N216117-001	9707217	2037-02-03		Drug product	2024-11-18
N216117-001	9827234	2037-02-03	U-4032		2024-11-18
N216117-001	9855258	2037-02-03	U-4032	Drug product	2024-11-18
N216117-002	10265308	2037-02-03	U-4032	Drug product	2024-11-18
N216117-002	10695336	2037-02-03	U-4032		2024-11-18
N216117-002	9707217	2037-02-03		Drug product	2024-11-18
N216117-002	9827234	2037-02-03	U-4032		2024-11-18
N216117-002	9855258	2037-02-03	U-4032	Drug product	2024-11-18
N216117-003	10265308	2037-02-03	U-4032	Drug product	2024-11-18
N216117-003	10695336	2037-02-03	U-4032		2024-11-18
N216117-003	9707217	2037-02-03		Drug product	2024-11-18
N216117-003	9827234	2037-02-03	U-4032		2024-11-18
N216117-003	9855258	2037-02-03	U-4032	Drug product	2024-11-18
N216117-004	10265308	2037-02-03	U-4032	Drug product	2024-11-18
N216117-004	10695336	2037-02-03	U-4032		2024-11-18
N216117-004	9707217	2037-02-03		Drug product	2024-11-18
N216117-004	9827234	2037-02-03	U-4032		2024-11-18
N216117-004	9855258	2037-02-03	U-4032	Drug product	2024-11-18
N216117-005	10265308	2037-02-03	U-4032	Drug product	2024-11-18
N216117-005	10695336	2037-02-03	U-4032		2024-11-18
N216117-005	9707217	2037-02-03		Drug product	2024-11-18
N216117-005	9827234	2037-02-03	U-4032		2024-11-18
N216117-005	9855258	2037-02-03	U-4032	Drug product	2024-11-18
N216117-006	10265308	2037-02-03	U-4032	Drug product	2024-11-18
N216117-006	10695336	2037-02-03	U-4032		2024-11-18
N216117-006	9707217	2037-02-03		Drug product	2024-11-18
N216117-006	9827234	2037-02-03	U-4032		2024-11-18
N216117-006	9855258	2037-02-03	U-4032	Drug product	2024-11-18
N216117-007	10265308	2037-02-03	U-4032	Drug product	2024-11-18
N216117-007	10695336	2037-02-03	U-4032		2024-11-18
N216117-007	9707217	2037-02-03		Drug product	2024-11-18
N216117-007	9827234	2037-02-03	U-4032		2024-11-18
N216117-007	9855258	2037-02-03	U-4032	Drug product	2024-11-18

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 5 · 196 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	N216117-001	RELEXXII	18MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216117-002	RELEXXII	27MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216117-003	RELEXXII	36MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216117-004	RELEXXII	45MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216117-005	RELEXXII	54MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216117-006	RELEXXII	63MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216117-007	RELEXXII	72MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-06-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216117-001	RELEXXII	18MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216117-002	RELEXXII	27MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216117-003	RELEXXII	36MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216117-004	RELEXXII	45MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216117-005	RELEXXII	54MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216117-006	RELEXXII	63MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216117-007	RELEXXII	72MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-06-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216117-001	RELEXXII	18MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-06-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216117-002	RELEXXII	27MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-06-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216117-003	RELEXXII	36MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-06-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216117-004	RELEXXII	45MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-06-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216117-005	RELEXXII	54MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-06-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216117-006	RELEXXII	63MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-06-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216117-007	RELEXXII	72MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-06-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216117-001	RELEXXII	18MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-06-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216117-002	RELEXXII	27MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-06-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216117-003	RELEXXII	36MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-06-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216117-004	RELEXXII	45MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-06-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216117-005	RELEXXII	54MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-06-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216117-006	RELEXXII	63MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-06-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216117-007	RELEXXII	72MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-06-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216117-001	RELEXXII	18MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-06-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216117-002	RELEXXII	27MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-06-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216117-003	RELEXXII	36MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-06-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216117-004	RELEXXII	45MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-06-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216117-005	RELEXXII	54MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-06-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216117-006	RELEXXII	63MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-06-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216117-007	RELEXXII	72MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-06-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216117-001	RELEXXII	18MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-06-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216117-002	RELEXXII	27MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-06-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216117-003	RELEXXII	36MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-06-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216117-004	RELEXXII	45MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-06-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216117-005	RELEXXII	54MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-06-23	`03ed91905a0d…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 280 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	N216117-001	10265308	2037-02-03	U-4032	Drug product	2024-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216117-001	10695336	2037-02-03	U-4032		2024-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216117-001	9707217	2037-02-03		Drug product	2024-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216117-001	9827234	2037-02-03	U-4032		2024-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216117-001	9855258	2037-02-03	U-4032	Drug product	2024-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216117-002	10265308	2037-02-03	U-4032	Drug product	2024-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216117-002	10695336	2037-02-03	U-4032		2024-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216117-002	9707217	2037-02-03		Drug product	2024-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216117-002	9827234	2037-02-03	U-4032		2024-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216117-002	9855258	2037-02-03	U-4032	Drug product	2024-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216117-003	10265308	2037-02-03	U-4032	Drug product	2024-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216117-003	10695336	2037-02-03	U-4032		2024-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216117-003	9707217	2037-02-03		Drug product	2024-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216117-003	9827234	2037-02-03	U-4032		2024-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216117-003	9855258	2037-02-03	U-4032	Drug product	2024-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216117-004	10265308	2037-02-03	U-4032	Drug product	2024-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216117-004	10695336	2037-02-03	U-4032		2024-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216117-004	9707217	2037-02-03		Drug product	2024-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216117-004	9827234	2037-02-03	U-4032		2024-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216117-004	9855258	2037-02-03	U-4032	Drug product	2024-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216117-005	10265308	2037-02-03	U-4032	Drug product	2024-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216117-005	10695336	2037-02-03	U-4032		2024-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216117-005	9707217	2037-02-03		Drug product	2024-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216117-005	9827234	2037-02-03	U-4032		2024-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216117-005	9855258	2037-02-03	U-4032	Drug product	2024-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216117-006	10265308	2037-02-03	U-4032	Drug product	2024-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216117-006	10695336	2037-02-03	U-4032		2024-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216117-006	9707217	2037-02-03		Drug product	2024-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216117-006	9827234	2037-02-03	U-4032		2024-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216117-006	9855258	2037-02-03	U-4032	Drug product	2024-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216117-007	10265308	2037-02-03	U-4032	Drug product	2024-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216117-007	10695336	2037-02-03	U-4032		2024-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216117-007	9707217	2037-02-03		Drug product	2024-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216117-007	9827234	2037-02-03	U-4032		2024-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216117-007	9855258	2037-02-03	U-4032	Drug product	2024-11-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216117-001	10265308	2037-02-03	U-4032	Drug product	2024-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216117-001	10695336	2037-02-03	U-4032		2024-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216117-001	9707217	2037-02-03		Drug product	2024-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216117-001	9827234	2037-02-03	U-4032		2024-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216117-001	9855258	2037-02-03	U-4032	Drug product	2024-11-18	`31067a03dcf5…`

Additional Listing Data#

Finished product: Yes
Brand name base: RELEXXII
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHYLPHENIDATE HYDROCHLORIDE	72 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 · 14 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1091155	Internal RxNorm lookup
1091170	Internal RxNorm lookup
1091185	Internal RxNorm lookup
1091210	Internal RxNorm lookup
1995461	Internal RxNorm lookup
2052826	Internal RxNorm lookup
2605796	Internal RxNorm lookup
2605798	Internal RxNorm lookup
2605943	Internal RxNorm lookup
2605946	Internal RxNorm lookup
2668496	Internal RxNorm lookup
2668499	Internal RxNorm lookup
2668502	Internal RxNorm lookup
2668505	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
22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
435f0341-cf24-41d5-8fbf-c909821e5596	Product name	1	20230313
c9b6eabb-08d7-bb2d-e81a-06be3590b436	Product name	2	20221216
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
67aa32c6-44f4-50de-64dd-643e8caf420d	Product name	6	20210622
50b24f34-96fa-4f1e-b262-b0baf4a4a440	Product name	4	20210513
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
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
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
7607489b-cd15-3103-f3b1-d4283574d250	Product name	2	20190614
407f0cce-da29-4050-a512-2cabe9e5692d	Product name	9	20190611
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
f7f4bf1e-7c67-46c6-8c42-9beb1a06b38e	Product name	2	20190415
190572d9-6c7b-4b40-8172-c1b5f802c20f	Product name	1	20180724
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
2948856e-f76e-d380-d9ed-b317efafbc98	Product name	5	20180423
c0aa09de-7aa1-4a98-8f70-62ec3c97c695	Product name	1	20170803
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
3317aade-2d6e-f159-9fe6-e8385a825178	Product name	3	20160829
0fe52203-83a7-4fed-a91f-8e47a22cf1d3	Product name	1	20160111
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68025-084-30	RELEXXII	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30		18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68025-084-10	EA - Each	68025-084	219aa3a9-d23d-48b7-8bb7-1e4b536ee375	1	2018-12-13
68025-084-30	EA - Each	68025-084	676cc0d2-7acc-4e0a-954d-01f4b273ca11	1	2019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68025-084	RELEXXII (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [VERTICAL PHARMACEUTICALS, LLC]	17	Current NDC, Legacy NDC, 1 package rows	20240809_22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RELEXXII	METHYLPHENIDATE HYDROCHLORIDE	Vertical Pharmaceuticals, LLC	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	2025-09-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 216117 application number: NDA216117 ndc (product): 68025-084
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Trigen Laboratories, LLC	dd8d7b6e-c23d-4e16-bb53-959e9127ebc6	2025-09-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 216117 application number: NDA216117

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
1091155	methylphenidate HCl 18 MG 24HR Extended Release Oral Tablet	PSN	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
1091170	methylphenidate HCl 27 MG 24HR Extended Release Oral Tablet	PSN	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
1091185	methylphenidate HCl 36 MG 24HR Extended Release Oral Tablet	PSN	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
1091210	methylphenidate HCl 54 MG 24HR Extended Release Oral Tablet	PSN	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
2605796	methylphenidate HCl 63 MG 24HR Extended Release Oral Tablet	PSN	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
1995461	methylphenidate HCl 72 MG 24HR Extended Release Oral Tablet	PSN	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
2605798	methylphenidate hydrochloride 45 MG 24HR Extended Release Oral Tablet	PSN	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
2668496	RELEXXII 18 MG 24HR Extended Release Oral Tablet	PSN	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
2668499	RELEXXII 27 MG 24HR Extended Release Oral Tablet	PSN	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
2668502	RELEXXII 36 MG 24HR Extended Release Oral Tablet	PSN	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
2605943	RELEXXII 45 MG 24HR Extended Release Oral Tablet	PSN	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
2668505	RELEXXII 54 MG 24HR Extended Release Oral Tablet	PSN	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
2605946	RELEXXII 63 MG 24HR Extended Release Oral Tablet	PSN	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
2052826	RELEXXII 72 MG 24HR Extended Release Oral Tablet	PSN	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
2668496	24 HR methylphenidate hydrochloride 18 MG Extended Release Oral Tablet [Relexxii]	SBD	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
2668499	24 HR methylphenidate hydrochloride 27 MG Extended Release Oral Tablet [Relexxii]	SBD	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
2668502	24 HR methylphenidate hydrochloride 36 MG Extended Release Oral Tablet [Relexxii]	SBD	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
2605943	24 HR methylphenidate hydrochloride 45 MG Extended Release Oral Tablet [Relexxii]	SBD	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
2668505	24 HR methylphenidate hydrochloride 54 MG Extended Release Oral Tablet [Relexxii]	SBD	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
2605946	24 HR methylphenidate hydrochloride 63 MG Extended Release Oral Tablet [Relexxii]	SBD	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
2052826	24 HR methylphenidate hydrochloride 72 MG Extended Release Oral Tablet [Relexxii]	SBD	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
1091155	24 HR methylphenidate hydrochloride 18 MG Extended Release Oral Tablet	SCD	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
1091170	24 HR methylphenidate hydrochloride 27 MG Extended Release Oral Tablet	SCD	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
1091185	24 HR methylphenidate hydrochloride 36 MG Extended Release Oral Tablet	SCD	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
2605798	24 HR methylphenidate hydrochloride 45 MG Extended Release Oral Tablet	SCD	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
1091210	24 HR methylphenidate hydrochloride 54 MG Extended Release Oral Tablet	SCD	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
2605796	24 HR methylphenidate hydrochloride 63 MG Extended Release Oral Tablet	SCD	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
1995461	24 HR methylphenidate hydrochloride 72 MG Extended Release Oral Tablet	SCD	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
2668496	24 HR Relexxii 18 MG Extended Release Oral Tablet	SY	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
2668499	24 HR Relexxii 27 MG Extended Release Oral Tablet	SY	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
2668502	24 HR Relexxii 36 MG Extended Release Oral Tablet	SY	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
2668505	24 HR Relexxii 54 MG Extended Release Oral Tablet	SY	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
2052826	24 HR Relexxii 72 MG Extended Release Oral Tablet	SY	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
1091155	methylphenidate hydrochloride 18 MG 24 HR Extended Release Oral Tablet	SY	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
1091170	methylphenidate hydrochloride 27 MG 24 HR Extended Release Oral Tablet	SY	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
1091185	methylphenidate hydrochloride 36 MG 24 HR Extended Release Oral Tablet	SY	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
2605798	methylphenidate hydrochloride 45 MG 24 HR Extended Release Oral Tablet	SY	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
1091210	methylphenidate hydrochloride 54 MG 24 HR Extended Release Oral Tablet	SY	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
2605796	methylphenidate hydrochloride 63 MG 24 HR Extended Release Oral Tablet	SY	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
1995461	methylphenidate hydrochloride 72 MG 24 HR Extended Release Oral Tablet	SY	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
2668496	Relexxii 18 MG 24 HR Extended Release Oral Tablet	SY	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
2668499	Relexxii 27 MG 24 HR Extended Release Oral Tablet	SY	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
2668502	Relexxii 36 MG 24 HR Extended Release Oral Tablet	SY	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
2605943	Relexxii 45 MG 24 HR Extended Release Oral Tablet	SY	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
2668505	Relexxii 54 MG 24 HR Extended Release Oral Tablet	SY	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
2605946	Relexxii 63 MG 24 HR Extended Release Oral Tablet	SY	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18
2052826	Relexxii 72 MG 24 HR Extended Release Oral Tablet	SY	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68025-084-10	68025008410	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-084-10)	2018-11-08	0000-00-00	No	No	Current
68025-084-30	68025008430	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-084-30)	2022-06-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
RELEXXII	Vertical Pharmaceuticals, LLC	2025-09-26	HUMAN PRESCRIPTION DRUG LABEL	18
RELEXXII	Vertical Pharmaceuticals, LLC	2021-11-24	HUMAN PRESCRIPTION DRUG LABEL	9