METADATE CD

Product NDC: 0527-6582
11-digit product format: 005276582
Labeler code: 0527
Product ID: 0527-6582_28336547-2194-432f-8dbd-f81b2cc4ef2d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methylphenidate hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Lannett Company, LLC
Application: NDA021259
Marketing category: NDA
Marketing start: 2024-02-22
Substance: METHYLPHENIDATE HYDROCHLORIDE
Active strength: 40 mg/1
Pharmacologic classes: Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule: CII
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 · 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 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021259-001	METADATE CD	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2001-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021259-002	METADATE CD	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2003-06-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021259-003	METADATE CD	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2003-05-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021259-004	METADATE CD	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2006-02-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021259-005	METADATE CD	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2006-02-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021259-006	METADATE CD	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2006-02-19	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N021259-001	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021259-002	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021259-003	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021259-004	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021259-005	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021259-006	AB2	1	`84e616aacf4f…`
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…`

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…`

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: METADATE CD
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHYLPHENIDATE HYDROCHLORIDE	40 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 · 12 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1091139	Internal RxNorm lookup
1091163	Internal RxNorm lookup
1091178	Internal RxNorm lookup
1091193	Internal RxNorm lookup
1091204	Internal RxNorm lookup
1091220	Internal RxNorm lookup
1806181	Internal RxNorm lookup
1806187	Internal RxNorm lookup
1806189	Internal RxNorm lookup
1806191	Internal RxNorm lookup
1806193	Internal RxNorm lookup
1806197	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
29f06562-6b6a-4ca6-b62e-d08a45fb3dd4	Available on FDA.report

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 ndc (product): 0527-6582
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
0527-6582-30	00527658230	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-6582-30)	2024-02-22	No	No	Current