Ritalin

Product NDC: 0078-0424
11-digit product format: 000780424
Labeler code: 0078
Product ID: 0078-0424_8f4647d0-4965-4dee-8f60-1340ef9be3de
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methylphenidate hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Novartis Pharmaceuticals Corporation
Application: NDA021284
Marketing category: NDA
Marketing start: 2002-06-05
Marketing end: 2026-10-31
Substance: METHYLPHENIDATE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule: CII
NDC exclude flag: No
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021284-001	RITALIN LA	METHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05
N021284-002	RITALIN LA	METHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05
N021284-003	RITALIN LA	METHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05
N021284-004	RITALIN LA	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2004-04-10
N021284-005	RITALIN LA	METHYLPHENIDATE HYDROCHLORIDE	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2014-10-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N021284-001	AB1
N021284-002	AB1
N021284-003	AB1
N021284-004	AB1

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021284-001	RITALIN LA	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021284-002	RITALIN LA	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021284-003	RITALIN LA	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021284-004	RITALIN LA	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2004-04-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021284-005	RITALIN LA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2014-10-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021284-001	RITALIN LA	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021284-002	RITALIN LA	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021284-003	RITALIN LA	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021284-004	RITALIN LA	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2004-04-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021284-005	RITALIN LA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2014-10-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021284-001	RITALIN LA	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021284-002	RITALIN LA	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021284-003	RITALIN LA	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021284-004	RITALIN LA	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2004-04-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021284-005	RITALIN LA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2014-10-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021284-001	RITALIN LA	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021284-002	RITALIN LA	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021284-003	RITALIN LA	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021284-004	RITALIN LA	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2004-04-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021284-005	RITALIN LA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2014-10-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021284-001	RITALIN LA	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021284-002	RITALIN LA	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021284-003	RITALIN LA	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021284-004	RITALIN LA	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2004-04-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021284-005	RITALIN LA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2014-10-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021284-001	RITALIN LA	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021284-002	RITALIN LA	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021284-003	RITALIN LA	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021284-004	RITALIN LA	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2004-04-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021284-005	RITALIN LA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2014-10-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021284-001	RITALIN LA	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021284-002	RITALIN LA	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021284-003	RITALIN LA	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021284-004	RITALIN LA	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2004-04-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021284-005	RITALIN LA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2014-10-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021284-001	RITALIN LA	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021284-002	RITALIN LA	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021284-003	RITALIN LA	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021284-004	RITALIN LA	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2004-04-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021284-005	RITALIN LA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2014-10-27	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021284-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021284-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021284-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021284-004	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021284-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021284-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021284-003	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021284-004	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021284-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021284-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021284-003	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021284-004	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021284-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021284-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021284-003	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021284-004	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021284-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021284-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021284-003	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021284-004	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021284-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021284-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021284-003	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021284-004	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021284-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021284-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021284-003	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021284-004	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021284-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021284-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021284-003	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021284-004	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021284-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021284-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021284-003	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021284-004	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021284-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021284-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021284-003	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021284-004	AB1	1	`d06236e962d9…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021284-001	6228398	2019-11-01	U-472	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021284-002	6228398	2019-11-01	U-472	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021284-003	6228398	2019-11-01	U-472	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021284-004	6228398	2019-11-01	U-472	Drug product	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021284-001	6228398	2019-11-01	U-472	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021284-002	6228398	2019-11-01	U-472	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021284-003	6228398	2019-11-01	U-472	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021284-004	6228398	2019-11-01	U-472	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021284-001	6228398	2019-11-01	U-472	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021284-002	6228398	2019-11-01	U-472	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021284-003	6228398	2019-11-01	U-472	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021284-004	6228398	2019-11-01	U-472	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021284-001	6228398	2019-11-01	U-472	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021284-002	6228398	2019-11-01	U-472	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021284-003	6228398	2019-11-01	U-472	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021284-004	6228398	2019-11-01	U-472	Drug product	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ritalin
Brand name suffix: LA

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHYLPHENIDATE HYDROCHLORIDE	10 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 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1091143	Internal RxNorm lookup
1091167	Internal RxNorm lookup
1091182	Internal RxNorm lookup
1091197	Internal RxNorm lookup
1806177	Internal RxNorm lookup
1806179	Internal RxNorm lookup
1806183	Internal RxNorm lookup
1806195	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
effd952d-ac94-47bb-b107-589a4934dcca	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
0078-0424-05	RitalinLA	100 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	100		36

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0078-0424-05	EA - Each	0078-0424	13555f85-cc76-4e76-84dc-1480818a4f18	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METHYLPHENIDATE HYDROCHLORIDE	ACTIVE INGREDIENT	4B3SC438HI	RITALIN LA (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	20
METHYLPHENIDATE	ACTIVE MOIETY	207ZZ9QZ49	RITALIN LA (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	20
DEXTROSE	INACTIVE INGREDIENT	IY9XDZ35W2	RITALIN LA (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	20
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	RITALIN LA (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	20
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	RITALIN LA (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	20
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	RITALIN LA (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	20
GELATIN	INACTIVE INGREDIENT	2G86QN327L	RITALIN LA (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	20
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	RITALIN LA (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	20
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	RITALIN LA (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	20
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	RITALIN LA (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	20
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	RITALIN LA (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0078-0424	RITALIN LA (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	33	Current NDC, Legacy NDC, 1 package rows	20231030_effd952d-ac94-47bb-b107-589a4934dcca.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	METHYLPHENIDATE	Sandoz Inc	1f8983ce-71b8-4c62-830d-e4692ddededa	2025-09-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021284 application number: NDA021284
Ritalin LA	METHYLPHENIDATE HYDROCHLORIDE	Novartis Pharmaceuticals Corporation	effd952d-ac94-47bb-b107-589a4934dcca	2025-09-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021284 application number: NDA021284 ndc (product): 0078-0424
Methylphenidate	METHYLPHENIDATE	Sandoz Inc	44386394-d2a3-4483-abe1-6c5c634cc501	2025-09-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021284 application number: NDA021284

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
1806195	methylphenidate HCl 10 MG 50/50 Release 24HR Extended Release Oral Capsule	PSN	effd952d-ac94-47bb-b107-589a4934dcca	36
1806177	methylphenidate HCl 20 MG 50/50 Release 24HR Extended Release Oral Capsule	PSN	effd952d-ac94-47bb-b107-589a4934dcca	36
1806179	methylphenidate HCl 30 MG 50/50 Release 24HR Extended Release Oral Capsule	PSN	effd952d-ac94-47bb-b107-589a4934dcca	36
1806183	methylphenidate HCl 40 MG 50/50 Release 24HR Extended Release Oral Capsule	PSN	effd952d-ac94-47bb-b107-589a4934dcca	36
1091143	Ritalin LA 10 MG 24HR Extended Release Oral Capsule	PSN	effd952d-ac94-47bb-b107-589a4934dcca	36
1091167	Ritalin LA 20 MG 24HR Extended Release Oral Capsule	PSN	effd952d-ac94-47bb-b107-589a4934dcca	36
1091182	Ritalin LA 30 MG 24HR Extended Release Oral Capsule	PSN	effd952d-ac94-47bb-b107-589a4934dcca	36
1091197	Ritalin LA 40 MG 24HR Extended Release Oral Capsule	PSN	effd952d-ac94-47bb-b107-589a4934dcca	36
1091143	50/50 Release 24 HR methylphenidate hydrochloride 10 MG Extended Release Oral Capsule [Ritalin]	SBD	effd952d-ac94-47bb-b107-589a4934dcca	36
1091167	50/50 Release 24 HR methylphenidate hydrochloride 20 MG Extended Release Oral Capsule [Ritalin]	SBD	effd952d-ac94-47bb-b107-589a4934dcca	36
1091182	50/50 Release 24 HR methylphenidate hydrochloride 30 MG Extended Release Oral Capsule [Ritalin]	SBD	effd952d-ac94-47bb-b107-589a4934dcca	36
1091197	50/50 Release 24 HR methylphenidate hydrochloride 40 MG Extended Release Oral Capsule [Ritalin]	SBD	effd952d-ac94-47bb-b107-589a4934dcca	36
1806195	50/50 Release 24 HR methylphenidate hydrochloride 10 MG Extended Release Oral Capsule	SCD	effd952d-ac94-47bb-b107-589a4934dcca	36
1806177	50/50 Release 24 HR methylphenidate hydrochloride 20 MG Extended Release Oral Capsule	SCD	effd952d-ac94-47bb-b107-589a4934dcca	36
1806179	50/50 Release 24 HR methylphenidate hydrochloride 30 MG Extended Release Oral Capsule	SCD	effd952d-ac94-47bb-b107-589a4934dcca	36
1806183	50/50 Release 24 HR methylphenidate hydrochloride 40 MG Extended Release Oral Capsule	SCD	effd952d-ac94-47bb-b107-589a4934dcca	36
1806195	methylphenidate HCl 10 MG 50/50 Release 24HR Extended Release Oral Capsule	SY	effd952d-ac94-47bb-b107-589a4934dcca	36
1806177	methylphenidate HCl 20 MG 50/50 Release 24HR Extended Release Oral Capsule	SY	effd952d-ac94-47bb-b107-589a4934dcca	36
1806179	methylphenidate HCl 30 MG 50/50 Release 24HR Extended Release Oral Capsule	SY	effd952d-ac94-47bb-b107-589a4934dcca	36
1806183	methylphenidate HCl 40 MG 50/50 Release 24HR Extended Release Oral Capsule	SY	effd952d-ac94-47bb-b107-589a4934dcca	36
1091143	Ritalin LA 10 MG 24HR Extended Release Oral Capsule	SY	effd952d-ac94-47bb-b107-589a4934dcca	36
1091167	Ritalin LA 20 MG 24 HR Extended Release Oral Capsule	SY	effd952d-ac94-47bb-b107-589a4934dcca	36
1091182	Ritalin LA 30 MG 24HR Extended Release Oral Capsule	SY	effd952d-ac94-47bb-b107-589a4934dcca	36
1091197	Ritalin LA 40 MG 24HR Extended Release Oral Capsule	SY	effd952d-ac94-47bb-b107-589a4934dcca	36

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0078-0424-05	00078042405	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0424-05)	2002-06-05	2026-09-30	No	No	Current