Application 091159

Type: ANDA
Sponsor: MOUNTAIN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
003	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	TABLET;ORAL	20MG	No	No

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

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	Approval date
A091159-001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2014-03-12
A091159-002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2014-03-12
A091159-003	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2014-03-12

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 · 123 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
2026-02-19 14:30 UTC	2026-02	A091159-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL		2014-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091159-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL		2014-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091159-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL		2014-03-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091159-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL		2014-03-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091159-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL		2014-03-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091159-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL		2014-03-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091159-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-03-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091159-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-03-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091159-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-03-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091159-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-03-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091159-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-03-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091159-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-03-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091159-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-03-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091159-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-03-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091159-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-03-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091159-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-03-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091159-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-03-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091159-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-03-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091159-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-03-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091159-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-03-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091159-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-03-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091159-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-03-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091159-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-03-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091159-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-03-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091159-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-03-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091159-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-03-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091159-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-03-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091159-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-03-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091159-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-03-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091159-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-03-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091159-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-03-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091159-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-03-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091159-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-03-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091159-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-03-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091159-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-03-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091159-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-03-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091159-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-03-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091159-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-03-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091159-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-03-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091159-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-03-12	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A091159-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091159-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091159-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091159-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091159-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091159-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091159-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091159-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091159-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091159-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091159-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091159-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091159-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091159-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091159-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091159-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091159-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091159-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091159-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091159-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091159-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091159-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091159-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091159-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091159-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091159-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091159-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091159-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091159-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091159-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091159-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091159-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091159-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091159-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091159-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091159-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091159-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091159-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091159-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091159-001	AB	1	`5d02ea3f76ae…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	c614cf55-b462-4f7e-b19c-6d22a47e509f	2025-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091159 application number: ANDA091159 ndc (product): 0115-1800 ndc (product): 0115-1802 ndc (product): 0115-1801
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	11f4ec97-ed86-48b5-af3a-446b882294cb	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091159 application number: ANDA091159
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	13a17c5a-bba7-4c5a-a4f9-2141bcdffa1a	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091159 application number: ANDA091159
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	1da9dc9e-7e8e-457a-93d4-9c2aee434e69	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091159 application number: ANDA091159

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0115-1800	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Impax Generics	ANDA	Current
0115-1800	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Impax Generics	ANDA	Current
0115-1800	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1800	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1800	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1800	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1801	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Impax Generics	ANDA	Current
0115-1801	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Impax Generics	ANDA	Current
0115-1801	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1801	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1801	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1801	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1802	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Impax Generics	ANDA	Current
0115-1802	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Impax Generics	ANDA	Current
0115-1802	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1802	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1802	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1802	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
64720-238	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	CorePharma, LLC	ANDA	Current
64720-239	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	CorePharma, LLC	ANDA	Current