METADATE CD

Product NDC: 69654-582
11-digit product format: 696540582
Labeler code: 69654
Product ID: 69654-582_43e0b75f-01c3-28cd-e063-6394a90a74a8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methylphenidate hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Aytu BioPharma, Inc.
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: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

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

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
be59f8b4-7842-42cc-9559-bfa747f0baa5	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69654-582-30	METADATE CD	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69654-582-30	EA - Each	69654-582	8814270f-07f8-4420-a7cb-43c322a4098c	1	2024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69654-582	METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [AYTU BIOPHARMA, INC.]	4	Current NDC, 1 package rows	20250119_be59f8b4-7842-42cc-9559-bfa747f0baa5.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 · 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 ndc (product): 69654-582

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	be59f8b4-7842-42cc-9559-bfa747f0baa5	6
1091163	Metadate CD 20 MG 24HR Extended Release Oral Capsule	PSN	be59f8b4-7842-42cc-9559-bfa747f0baa5	6
1091178	Metadate CD 30 MG 24HR Extended Release Oral Capsule	PSN	be59f8b4-7842-42cc-9559-bfa747f0baa5	6
1091193	Metadate CD 40 MG 24HR Extended Release Oral Capsule	PSN	be59f8b4-7842-42cc-9559-bfa747f0baa5	6
1091204	Metadate CD 50 MG 24HR Extended Release Oral Capsule	PSN	be59f8b4-7842-42cc-9559-bfa747f0baa5	6
1091220	Metadate CD 60 MG 24HR Extended Release Oral Capsule	PSN	be59f8b4-7842-42cc-9559-bfa747f0baa5	6
1806181	methylphenidate HCl 10 MG 30/70 Release 24HR Extended Release Oral Capsule	PSN	be59f8b4-7842-42cc-9559-bfa747f0baa5	6
1806187	methylphenidate HCl 20 MG 30/70 Release 24HR Extended Release Oral Capsule	PSN	be59f8b4-7842-42cc-9559-bfa747f0baa5	6
1806189	methylphenidate HCl 30 MG 30/70 Release 24HR Extended Release Oral Capsule	PSN	be59f8b4-7842-42cc-9559-bfa747f0baa5	6
1806191	methylphenidate HCl 40 MG 30/70 Release 24HR Extended Release Oral Capsule	PSN	be59f8b4-7842-42cc-9559-bfa747f0baa5	6
1806193	methylphenidate HCl 50 MG 30/70 Release 24HR Extended Release Oral Capsule	PSN	be59f8b4-7842-42cc-9559-bfa747f0baa5	6
1806197	methylphenidate HCl 60 MG 30/70 Release 24HR Extended Release Oral Capsule	PSN	be59f8b4-7842-42cc-9559-bfa747f0baa5	6
1091139	30/70 Release 24 HR methylphenidate hydrochloride 10 MG Extended Release Oral Capsule [Metadate]	SBD	be59f8b4-7842-42cc-9559-bfa747f0baa5	6
1091163	30/70 Release 24 HR methylphenidate hydrochloride 20 MG Extended Release Oral Capsule [Metadate]	SBD	be59f8b4-7842-42cc-9559-bfa747f0baa5	6
1091178	30/70 Release 24 HR methylphenidate hydrochloride 30 MG Extended Release Oral Capsule [Metadate]	SBD	be59f8b4-7842-42cc-9559-bfa747f0baa5	6
1091193	30/70 Release 24 HR methylphenidate hydrochloride 40 MG Extended Release Oral Capsule [Metadate]	SBD	be59f8b4-7842-42cc-9559-bfa747f0baa5	6
1091204	30/70 Release 24 HR methylphenidate hydrochloride 50 MG Extended Release Oral Capsule [Metadate]	SBD	be59f8b4-7842-42cc-9559-bfa747f0baa5	6
1091220	30/70 Release 24 HR methylphenidate hydrochloride 60 MG Extended Release Oral Capsule [Metadate]	SBD	be59f8b4-7842-42cc-9559-bfa747f0baa5	6
1806181	30/70 Release 24 HR methylphenidate hydrochloride 10 MG Extended Release Oral Capsule	SCD	be59f8b4-7842-42cc-9559-bfa747f0baa5	6
1806187	30/70 Release 24 HR methylphenidate hydrochloride 20 MG Extended Release Oral Capsule	SCD	be59f8b4-7842-42cc-9559-bfa747f0baa5	6
1806189	30/70 Release 24 HR methylphenidate hydrochloride 30 MG Extended Release Oral Capsule	SCD	be59f8b4-7842-42cc-9559-bfa747f0baa5	6
1806191	30/70 Release 24 HR methylphenidate hydrochloride 40 MG Extended Release Oral Capsule	SCD	be59f8b4-7842-42cc-9559-bfa747f0baa5	6
1806193	30/70 Release 24 HR methylphenidate hydrochloride 50 MG Extended Release Oral Capsule	SCD	be59f8b4-7842-42cc-9559-bfa747f0baa5	6
1806197	30/70 Release 24 HR methylphenidate hydrochloride 60 MG Extended Release Oral Capsule	SCD	be59f8b4-7842-42cc-9559-bfa747f0baa5	6
1091139	Metadate CD 10 MG 24 HR Extended Release Oral Capsule	SY	be59f8b4-7842-42cc-9559-bfa747f0baa5	6
1091163	Metadate CD 20 MG 24HR Extended Release Oral Capsule	SY	be59f8b4-7842-42cc-9559-bfa747f0baa5	6
1091178	Metadate CD 30 MG 24HR Extended Release Oral Capsule	SY	be59f8b4-7842-42cc-9559-bfa747f0baa5	6
1091193	Metadate CD 40 MG 24HR Extended Release Oral Capsule	SY	be59f8b4-7842-42cc-9559-bfa747f0baa5	6
1091204	Metadate CD 50 MG 24HR Extended Release Oral Capsule	SY	be59f8b4-7842-42cc-9559-bfa747f0baa5	6
1091220	Metadate CD 60 MG 24HR Extended Release Oral Capsule	SY	be59f8b4-7842-42cc-9559-bfa747f0baa5	6
1806181	methylphenidate HCl 10 MG 30/70 Release 24HR Extended Release Oral Capsule	SY	be59f8b4-7842-42cc-9559-bfa747f0baa5	6
1806187	methylphenidate HCl 20 MG 30/70 Release 24HR Extended Release Oral Capsule	SY	be59f8b4-7842-42cc-9559-bfa747f0baa5	6
1806189	methylphenidate HCl 30 MG 30/70 Release 24HR Extended Release Oral Capsule	SY	be59f8b4-7842-42cc-9559-bfa747f0baa5	6
1806191	methylphenidate HCl 40 MG 30/70 Release 24HR Extended Release Oral Capsule	SY	be59f8b4-7842-42cc-9559-bfa747f0baa5	6
1806193	methylphenidate HCl 50 MG 30/70 Release 24HR Extended Release Oral Capsule	SY	be59f8b4-7842-42cc-9559-bfa747f0baa5	6
1806197	methylphenidate HCl 60 MG 30/70 Release 24HR Extended Release Oral Capsule	SY	be59f8b4-7842-42cc-9559-bfa747f0baa5	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
69654-582-30	69654058230	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69654-582-30)	2024-02-22	No	No	Current