Application 010187

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
003	RITALIN	METHYLPHENIDATE HYDROCHLORIDE	TABLET;ORAL	5MG	Yes	No
006	RITALIN	METHYLPHENIDATE HYDROCHLORIDE	TABLET;ORAL	10MG	Yes	No
010	RITALIN	METHYLPHENIDATE HYDROCHLORIDE	TABLET;ORAL	20MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS
N010187-003	RITALIN	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RLD, Approved before 1982
N010187-006	RITALIN	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982
N010187-010	RITALIN	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N010187-003	AB
N010187-006	AB
N010187-010	AB

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N010187-003	RITALIN	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N010187-006	RITALIN	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N010187-010	RITALIN	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N010187-003	RITALIN	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N010187-006	RITALIN	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N010187-010	RITALIN	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N010187-003	RITALIN	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N010187-006	RITALIN	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N010187-010	RITALIN	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010187-003	RITALIN	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010187-006	RITALIN	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010187-010	RITALIN	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N010187-003	RITALIN	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N010187-006	RITALIN	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N010187-010	RITALIN	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010187-003	RITALIN	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010187-006	RITALIN	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010187-010	RITALIN	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N010187-003	RITALIN	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N010187-006	RITALIN	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N010187-010	RITALIN	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N010187-003	RITALIN	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N010187-006	RITALIN	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N010187-010	RITALIN	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N010187-003	RITALIN	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N010187-006	RITALIN	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N010187-010	RITALIN	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N010187-003	RITALIN	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N010187-006	RITALIN	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N010187-010	RITALIN	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N010187-003	RITALIN	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N010187-006	RITALIN	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N010187-010	RITALIN	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N010187-003	RITALIN	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N010187-006	RITALIN	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N010187-010	RITALIN	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N010187-003	RITALIN	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N010187-006	RITALIN	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N010187-010	RITALIN	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N010187-003	RITALIN	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-14 00:12 UTC	2019-12	N010187-010	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N010187-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N010187-006	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N010187-010	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N010187-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N010187-006	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N010187-010	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N010187-003	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N010187-006	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N010187-010	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N010187-003	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N010187-006	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N010187-010	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N010187-003	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N010187-006	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N010187-010	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N010187-003	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N010187-006	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N010187-010	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N010187-003	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N010187-006	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N010187-010	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N010187-003	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N010187-006	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N010187-010	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N010187-003	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N010187-006	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N010187-010	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N010187-003	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N010187-006	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N010187-010	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N010187-003	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N010187-006	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N010187-010	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N010187-003	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N010187-006	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N010187-010	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N010187-003	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N010187-006	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N010187-010	AB	1	`f41ea6bd6efb…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ritalin	METHYLPHENIDATE HYDROCHLORIDE	Sandoz Inc	d6fb2750-cdab-4749-ba0d-7534840a5892	2025-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 010187 application number: NDA010187

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0439	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0439	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0439	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0439	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0439	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0439	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0439	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0440	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0440	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0440	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0440	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0440	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0440	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0440	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0441	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0441	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0441	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0441	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0441	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0441	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0441	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0781-5748	Methylphenidate Hydrochloride	methylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5748	Methylphenidate Hydrochloride	methylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5749	Methylphenidate Hydrochloride	methylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5749	Methylphenidate Hydrochloride	methylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5753	Methylphenidate Hydrochloride	methylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5753	Methylphenidate Hydrochloride	methylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
63629-3166	Methylphenidate Hydrochloride	methylphenidate hydrochloride	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-3166	Methylphenidate Hydrochloride	methylphenidate hydrochloride	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
71335-0838	Methylphenidate Hydrochloride	methylphenidate hydrochloride	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
71335-0838	Methylphenidate Hydrochloride	methylphenidate hydrochloride	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81055	SUPPL	2025-02-06
81054	SUPPL	2025-02-06
80962	SUPPL	2025-02-05
75819	SUPPL	2023-10-17
75818	SUPPL	2023-10-17
75747	SUPPL	2023-10-16
75746	SUPPL	2023-10-16
67969	SUPPL	2021-06-29
67968	SUPPL	2021-06-29
67950	SUPPL	2021-06-29
60988	SUPPL	2019-11-20
60987	SUPPL	2019-11-20
60982	SUPPL	2019-11-20
57265	SUPPL	2019-01-18
57264	SUPPL	2019-01-18
57184	SUPPL	2019-01-11
57183	SUPPL	2019-01-11
57182	SUPPL	2019-01-11
57181	SUPPL	2019-01-11
46824	SUPPL	2017-01-13
46823	SUPPL	2017-01-13
46705	SUPPL	2017-01-06
33014	SUPPL	2015-04-21
216	SUPPL	2015-04-21
10748	SUPPL	2013-12-17
11896	SUPPL	2013-12-16
33013	SUPPL	2013-06-11
215	SUPPL	2013-06-11
214	SUPPL	2010-12-15
33012	SUPPL	2010-12-10
213	SUPPL	2010-11-18
10747	SUPPL	2010-11-17
23528	ORIG	2007-05-10
10746	SUPPL	2007-05-01
212	SUPPL	2007-05-01
211	SUPPL	2006-08-11
210	SUPPL	2006-08-11
10745	SUPPL	2006-08-09
10744	SUPPL	2006-08-09
208	SUPPL	2004-05-27
207	SUPPL	2004-05-27
209	SUPPL	2002-01-11