Metadate CD

Product NDC: 53014-581
11-digit product format: 530140581
Labeler code: 53014
Product ID: 53014-581_bb9a02a4-3803-482d-970d-0f27f3b6f452
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methylphenidate hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Unither Manufacturing, LLC
Application: NDA021259
Marketing category: NDA
Marketing start: 2003-07-22
Marketing end: 0000-00-00
Substance: METHYLPHENIDATE HYDROCHLORIDE
Active strength: 30 mg/1
Pharmacologic classes: Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA schedule: CII
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53014-581		D	Discontinued by firm		2026-08-17
excluded package	package	53014-581	53014-581-07	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 26 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53014-581-07	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53014-581-07	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53014-581-07	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53014-581-07	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53014-581-07	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53014-581-07	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53014-581-07	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53014-581-07	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53014-581-07	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53014-581-07	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53014-581-07	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53014-581-07	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	53014-581-07	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021259-001	METADATE CD	METHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2001-04-03
N021259-002	METADATE CD	METHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2003-06-19
N021259-003	METADATE CD	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2003-05-27
N021259-004	METADATE CD	METHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2006-02-19
N021259-005	METADATE CD	METHYLPHENIDATE HYDROCHLORIDE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2006-02-19
N021259-006	METADATE CD	METHYLPHENIDATE HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2006-02-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
N021259-001	AB2
N021259-002	AB2
N021259-003	AB2
N021259-004	AB2
N021259-005	AB2
N021259-006	AB2

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 7 · 252 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
2026-08-18 06:07:40	2026-07	N021259-001	METADATE CD	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2001-04-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021259-002	METADATE CD	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2003-06-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021259-003	METADATE CD	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2003-05-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021259-004	METADATE CD	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2006-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021259-005	METADATE CD	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2006-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021259-006	METADATE CD	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2006-02-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021259-001	METADATE CD	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2001-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021259-002	METADATE CD	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2003-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021259-003	METADATE CD	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2003-05-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021259-004	METADATE CD	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2006-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021259-005	METADATE CD	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2006-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021259-006	METADATE CD	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2006-02-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021259-001	METADATE CD	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2001-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021259-002	METADATE CD	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2003-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021259-003	METADATE CD	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2003-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021259-004	METADATE CD	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2006-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021259-005	METADATE CD	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2006-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021259-006	METADATE CD	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2006-02-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021259-001	METADATE CD	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2001-04-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021259-002	METADATE CD	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2003-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021259-003	METADATE CD	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2003-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021259-004	METADATE CD	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2006-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021259-005	METADATE CD	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2006-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021259-006	METADATE CD	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2006-02-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021259-001	METADATE CD	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2001-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021259-002	METADATE CD	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2003-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021259-003	METADATE CD	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2003-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021259-004	METADATE CD	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2006-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021259-005	METADATE CD	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2006-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021259-006	METADATE CD	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2006-02-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021259-001	METADATE CD	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2001-04-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021259-002	METADATE CD	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2003-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021259-003	METADATE CD	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2003-05-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021259-004	METADATE CD	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2006-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021259-005	METADATE CD	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2006-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021259-006	METADATE CD	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2006-02-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021259-001	METADATE CD	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2001-04-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021259-002	METADATE CD	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2003-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021259-003	METADATE CD	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2003-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021259-004	METADATE CD	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2006-02-19	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 252 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N021259-001	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021259-002	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021259-003	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021259-004	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021259-005	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021259-006	AB2	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021259-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021259-002	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021259-003	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021259-004	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021259-005	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021259-006	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021259-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021259-002	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021259-003	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021259-004	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021259-005	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021259-006	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021259-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021259-002	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021259-003	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021259-004	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021259-005	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021259-006	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021259-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021259-002	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021259-003	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021259-004	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021259-005	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021259-006	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021259-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021259-002	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021259-003	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021259-004	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021259-005	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021259-006	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021259-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021259-002	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021259-003	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021259-004	AB2	1	`03ed91905a0d…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021259-001	6344215	2020-10-27	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021259-002	6344215	2020-10-27	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021259-003	6344215	2020-10-27	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021259-004	6344215	2020-10-27	Drug product	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021259-001	6344215	2020-10-27	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021259-002	6344215	2020-10-27	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021259-003	6344215	2020-10-27	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021259-004	6344215	2020-10-27	Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021259-001	6344215	2020-10-27	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021259-002	6344215	2020-10-27	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021259-003	6344215	2020-10-27	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021259-004	6344215	2020-10-27	Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021259-001	6344215	2020-10-27	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021259-002	6344215	2020-10-27	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021259-003	6344215	2020-10-27	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021259-004	6344215	2020-10-27	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021259-001	6344215	2020-10-27	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021259-002	6344215	2020-10-27	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021259-003	6344215	2020-10-27	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021259-004	6344215	2020-10-27	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021259-001	6344215	2020-10-27	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021259-002	6344215	2020-10-27	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021259-003	6344215	2020-10-27	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021259-004	6344215	2020-10-27	Drug product	`ea99ee380514…`

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53014-581-07	EA - Each	53014-581	dd9cbc56-32c4-4de6-83a1-66590f46b034	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
methylphenidate hydrochloride	ACTIVE INGREDIENT	4B3SC438HI	METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC]	13
methylphenidate	ACTIVE MOIETY	207ZZ9QZ49	METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC]	13
dibutyl sebacate	INACTIVE INGREDIENT	4W5IH7FLNY	METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC]	13
ethylcelluloses	INACTIVE INGREDIENT	7Z8S9VYZ4B	METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC]	13
FD&C Blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC]	13
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC]	13
Ferric Oxide Yellow	INACTIVE INGREDIENT	EX438O2MRT	METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC]	13
gelatin	INACTIVE INGREDIENT	2G86QN327L	METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC]	13
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC]	13
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC]	13
povidones	INACTIVE INGREDIENT	FZ989GH94E	METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC]	13
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC]	13
METHYLPHENIDATE HYDROCHLORIDE	ACTIVE INGREDIENT	4B3SC438HI	METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
METHYLPHENIDATE	ACTIVE MOIETY	207ZZ9QZ49	METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
DIBUTYL SEBACATE	INACTIVE INGREDIENT	4W5IH7FLNY	METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
methylphenidate hydrochloride CD	METHYLPHENIDATE HYDROCHLORIDE	Lannett Company, LLC	e45c75dc-d381-475b-b649-a871c8a36e60	2026-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021259 application number: NDA021259
METADATE CD	METHYLPHENIDATE HYDROCHLORIDE	Lannett Company, LLC	29f06562-6b6a-4ca6-b62e-d08a45fb3dd4	2026-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021259 application number: NDA021259
METADATE CD	METHYLPHENIDATE HYDROCHLORIDE	Aytu BioPharma, Inc.	be59f8b4-7842-42cc-9559-bfa747f0baa5	2025-11-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021259 application number: NDA021259

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
1091139	Metadate CD 10 MG 24HR Extended Release Oral Capsule	PSN	be6f8d00-9281-4f67-b8fc-3de58a4d14f4	1
1091163	Metadate CD 20 MG 24HR Extended Release Oral Capsule	PSN	be6f8d00-9281-4f67-b8fc-3de58a4d14f4	1
1091178	Metadate CD 30 MG 24HR Extended Release Oral Capsule	PSN	be6f8d00-9281-4f67-b8fc-3de58a4d14f4	1
1091204	Metadate CD 50 MG 24HR Extended Release Oral Capsule	PSN	be6f8d00-9281-4f67-b8fc-3de58a4d14f4	1
1806181	methylphenidate HCl 10 MG 30/70 Release 24HR Extended Release Oral Capsule	PSN	be6f8d00-9281-4f67-b8fc-3de58a4d14f4	1
1806187	methylphenidate HCl 20 MG 30/70 Release 24HR Extended Release Oral Capsule	PSN	be6f8d00-9281-4f67-b8fc-3de58a4d14f4	1
1806189	methylphenidate HCl 30 MG 30/70 Release 24HR Extended Release Oral Capsule	PSN	be6f8d00-9281-4f67-b8fc-3de58a4d14f4	1
1806193	methylphenidate HCl 50 MG 30/70 Release 24HR Extended Release Oral Capsule	PSN	be6f8d00-9281-4f67-b8fc-3de58a4d14f4	1
1091139	30/70 Release 24 HR methylphenidate hydrochloride 10 MG Extended Release Oral Capsule [Metadate]	SBD	be6f8d00-9281-4f67-b8fc-3de58a4d14f4	1
1091163	30/70 Release 24 HR methylphenidate hydrochloride 20 MG Extended Release Oral Capsule [Metadate]	SBD	be6f8d00-9281-4f67-b8fc-3de58a4d14f4	1
1091178	30/70 Release 24 HR methylphenidate hydrochloride 30 MG Extended Release Oral Capsule [Metadate]	SBD	be6f8d00-9281-4f67-b8fc-3de58a4d14f4	1
1091204	30/70 Release 24 HR methylphenidate hydrochloride 50 MG Extended Release Oral Capsule [Metadate]	SBD	be6f8d00-9281-4f67-b8fc-3de58a4d14f4	1
1806181	30/70 Release 24 HR methylphenidate hydrochloride 10 MG Extended Release Oral Capsule	SCD	be6f8d00-9281-4f67-b8fc-3de58a4d14f4	1
1806187	30/70 Release 24 HR methylphenidate hydrochloride 20 MG Extended Release Oral Capsule	SCD	be6f8d00-9281-4f67-b8fc-3de58a4d14f4	1
1806189	30/70 Release 24 HR methylphenidate hydrochloride 30 MG Extended Release Oral Capsule	SCD	be6f8d00-9281-4f67-b8fc-3de58a4d14f4	1
1806193	30/70 Release 24 HR methylphenidate hydrochloride 50 MG Extended Release Oral Capsule	SCD	be6f8d00-9281-4f67-b8fc-3de58a4d14f4	1
1091139	Metadate CD 10 MG 24 HR Extended Release Oral Capsule	SY	be6f8d00-9281-4f67-b8fc-3de58a4d14f4	1
1091163	Metadate CD 20 MG 24HR Extended Release Oral Capsule	SY	be6f8d00-9281-4f67-b8fc-3de58a4d14f4	1
1091178	Metadate CD 30 MG 24HR Extended Release Oral Capsule	SY	be6f8d00-9281-4f67-b8fc-3de58a4d14f4	1
1091204	Metadate CD 50 MG 24HR Extended Release Oral Capsule	SY	be6f8d00-9281-4f67-b8fc-3de58a4d14f4	1
1806181	methylphenidate HCl 10 MG 30/70 Release 24HR Extended Release Oral Capsule	SY	be6f8d00-9281-4f67-b8fc-3de58a4d14f4	1
1806187	methylphenidate HCl 20 MG 30/70 Release 24HR Extended Release Oral Capsule	SY	be6f8d00-9281-4f67-b8fc-3de58a4d14f4	1
1806189	methylphenidate HCl 30 MG 30/70 Release 24HR Extended Release Oral Capsule	SY	be6f8d00-9281-4f67-b8fc-3de58a4d14f4	1
1806193	methylphenidate HCl 50 MG 30/70 Release 24HR Extended Release Oral Capsule	SY	be6f8d00-9281-4f67-b8fc-3de58a4d14f4	1

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metadate CD ® (methylphenidate HCl, USP) Extended-Release Capsules CII	McKesson Corporation dba RX Pak	2019-09-05	HUMAN PRESCRIPTION DRUG LABEL	10
Metadate CD ® (methylphenidate HCl, USP) Extended-Release Capsules CII	Unither Manufacturing, LLC	2016-10-11	HUMAN PRESCRIPTION DRUG LABEL	14
Metadate CD ® (methylphenidate HCl, USP) Extended-Release Capsules CII	Physicians Total Care, Inc.	2010-11-01	HUMAN PRESCRIPTION DRUG LABEL	1