Application 085799

Type: ANDA
Sponsor: LANNETT CO INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	TABLET;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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A085799-001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL		Approved before 1982

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	A085799-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A085799-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A085799-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085799-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085799-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085799-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085799-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085799-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085799-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085799-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085799-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085799-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085799-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085799-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085799-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085799-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085799-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085799-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085799-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085799-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085799-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085799-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085799-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085799-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085799-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085799-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085799-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085799-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085799-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085799-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085799-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085799-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085799-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085799-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085799-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085799-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085799-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085799-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085799-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085799-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`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 3 of 4 · 74 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Cranbury Pharmaceuticals, LLC	e817377f-bc72-415a-acd2-7136746b2479	2025-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate Hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	b77128b3-fce4-4bee-bdad-5fe4af9d612d	2024-11-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METHYLPHENIDATE HYDROCHLORIDE generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	c87a2000-b75c-41df-8497-7e00a9b41ad4	2024-11-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METHYLPHENIDATE HYDROCHLORIDE generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	371346d1-ac7e-491c-a010-ad29cb3d567a	2024-11-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METHYLPHENIDATE HYDROCHLORIDE generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	ec3d9304-13bc-4f0b-bf14-1a1ea824bd91	2024-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METHYLPHENIDATE HYDROCHLORIDE generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride Extended-Release	METHYLPHENIDATE HYDROCHLORIDE	SpecGx LLC	b1b0f2ff-d9df-42ab-b471-226ecf97e075	2024-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Ascend Laboratories, LLC	8e97c9f3-956c-416a-a7c2-68bb92053ce5	2024-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate Hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Accord Healthcare, Inc.	4f3c91e6-4576-4326-bdab-7d8fb7c09bb8	2024-06-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METHYLPHENIDATE HYDROCHLORIDE generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	11f4ec97-ed86-48b5-af3a-446b882294cb	2024-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METHYLPHENIDATE HYDROCHLORIDE generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	13a17c5a-bba7-4c5a-a4f9-2141bcdffa1a	2024-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METHYLPHENIDATE HYDROCHLORIDE generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	1da9dc9e-7e8e-457a-93d4-9c2aee434e69	2024-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METHYLPHENIDATE HYDROCHLORIDE generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	b9c31526-d486-433c-9b3c-7a12765afe94	2024-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate Hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	83e70f8f-18dd-45fc-8bc5-4b8f7f23439e	2024-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate Hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	ad3a3865-952e-46cf-8387-1228e2375312	2024-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate Hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	ea5a6d4e-60ba-46f3-b314-3c7a970b377d	2024-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate Hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Lupin Pharmaceuticals,Inc.	ec8a8896-077d-4dee-9e10-97172512c5ed	2024-03-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate Hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Nivagen Pharmaceuticals, Inc.	4cc16009-44ad-4055-ac76-efa282f1ff47	2024-02-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METHYLPHENIDATE HYDROCHLORIDE generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	7293dffd-eb01-43d4-b9c4-04f79bec180c	2024-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate Hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	213ca0da-dde8-48ee-ac8c-c66558e6f62d	2024-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate Hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	b49863bd-20ba-44d5-8dab-96fcbd276a5c	2024-01-10	Warnings, Adverse reactions	Name fallback brand name: Methylphenidate Hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0527-2530	Methylphenidate Hydrochloride	methylphenidate hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-2530	Methylphenidate Hydrochloride	methylphenidate hydrochloride	Lannett Company, Inc.	ANDA	Current
53014-530	Methylphenidate Hydrochloride	methylphenidate hydrochloride	Unither Manufacturing, LLC	ANDA	Current
65580-530	Methylphenidate Hydrochloride	methylphenidate hydrochloride	Upstate Pharma, LLC	ANDA	Current