Application 205756

Type: ANDA
Sponsor: RISING

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	TABLET, CHEWABLE;ORAL	2.5MG	No	No
002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	TABLET, CHEWABLE;ORAL	5MG	No	No
003	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	TABLET, CHEWABLE;ORAL	10MG	No	No

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	Approval date
A205756-001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07
A205756-002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07
A205756-003	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205756-001	AB
A205756-002	AB
A205756-003	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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A205756-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205756-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205756-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205756-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205756-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205756-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205756-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205756-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205756-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205756-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205756-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205756-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205756-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205756-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205756-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205756-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205756-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205756-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205756-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205756-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205756-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205756-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205756-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205756-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205756-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205756-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205756-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205756-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205756-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205756-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205756-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205756-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205756-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205756-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205756-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205756-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205756-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205756-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205756-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205756-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB	2016-11-07	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205756-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205756-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205756-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205756-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205756-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205756-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205756-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205756-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205756-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205756-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205756-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205756-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205756-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205756-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205756-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205756-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205756-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205756-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205756-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205756-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205756-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205756-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205756-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205756-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205756-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205756-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205756-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205756-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205756-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205756-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A205756-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A205756-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205756-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A205756-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A205756-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205756-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A205756-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A205756-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205756-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205756-002	AB	1	`3f01610625f2…`

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
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	e5cb0740-813f-4dce-8c29-d7680c66e77c	2025-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205756 application number: ANDA205756 ndc (product): 64980-221 ndc (product): 64980-223 ndc (product): 64980-222

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
64980-221	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-221	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-222	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-222	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-223	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-223	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Rising Pharmaceuticals, Inc.	ANDA	Current