Application 206734

Type: ANDA
Sponsor: SUN PHARM INDS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	5MG	No	No
002	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	10MG	No	No
003	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	15MG	No	No
004	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	20MG	No	No
005	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	25MG	No	No
006	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	30MG	No	No
007	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	35MG	No	No
008	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	40MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A206734-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05
A206734-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05
A206734-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05
A206734-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05
A206734-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05
A206734-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05
A206734-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05
A206734-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05

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 7 · 280 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A206734-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206734-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206734-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206734-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206734-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206734-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206734-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206734-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206734-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206734-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206734-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206734-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206734-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206734-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206734-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206734-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206734-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206734-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206734-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206734-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206734-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206734-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206734-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206734-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206734-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206734-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206734-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206734-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206734-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206734-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206734-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206734-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206734-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206734-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206734-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206734-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206734-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206734-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206734-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206734-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`6a471c1ec25d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 232 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206734-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206734-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206734-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206734-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206734-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206734-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206734-007	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206734-008	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206734-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206734-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206734-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206734-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206734-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206734-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206734-007	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206734-008	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206734-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206734-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206734-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206734-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206734-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206734-006	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206734-007	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206734-008	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206734-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206734-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206734-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206734-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206734-005	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206734-006	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206734-007	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206734-008	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206734-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206734-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206734-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206734-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206734-005	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206734-006	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206734-007	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206734-008	AB	1	`5bbf6a4d5a75…`

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 2 of 2 · 40 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	06bcef7a-b321-4dd8-9bf6-5d8f8940f04a	2024-08-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	a03d8819-a315-4337-ac50-530af98082b0	2024-08-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	424da264-7448-4364-939f-d3ebbee1a6d7	2024-08-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	d3318fec-a1bc-4e3c-86a9-3f00ec296869	2024-08-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	c423a632-e8e0-44a7-a8a8-f66cec81aa64	2024-08-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Cranbury Pharmaceuticals, LLC	1f2aa66a-51dc-459c-a765-5364bccd310f	2024-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Ascend Laboratories, LLC	830df993-db01-40df-beef-90af6b86f561	2024-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	f930af78-760b-42c7-af30-ffcc64c4d35d	2024-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride Extended-Release	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	a0133bf5-3cb3-4405-a007-43fbcf957333	2024-05-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride Extended-Release	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	32b3c189-f0f8-4f3e-87da-ce56f583fc42	2024-05-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Focalin	DEXMETHYLPHENIDATE HYDROCHLORIDE	Sandoz Inc	2016f5c2-95d2-4655-af65-c588c2bf5e6d	2024-05-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	17950616-ab96-4d7e-be48-f36cae547de0	2024-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	f65759db-5294-4e82-bb3c-3ea368edaca7	2024-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	ea04c0e3-0be3-4607-bd59-29f611e6681b	2024-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Par Health USA, LLC	e304388e-86a6-4335-abae-0ce79c7c99c6	2024-01-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Lupin Pharmaceuticals,Inc.	a61932ef-c2b6-4363-a21d-1f0358f317b6	2024-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	194bb3a5-5f6c-49e3-85ab-ac557b3f8bbd	2024-01-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	f88da72d-c22f-413b-9dce-60871299b06a	2024-01-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	987b4983-1edc-40f1-adc9-724747080969	2024-01-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	77659abe-74be-4092-90fe-cc475726d4ec	2021-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DEXMETHYLPHENIDATE HYDROCHLORIDE generic name: DEXMETHYLPHENIDATE 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 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-562	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Northstar Rx LLC	ANDA	Current
16714-563	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Northstar Rx LLC	ANDA	Current
16714-564	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Northstar Rx LLC	ANDA	Current
16714-565	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Northstar Rx LLC	ANDA	Current
16714-566	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Northstar Rx LLC	ANDA	Current
16714-567	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Northstar Rx LLC	ANDA	Current
16714-568	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Northstar Rx LLC	ANDA	Current
16714-569	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Northstar Rx LLC	ANDA	Current
57664-621	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-622	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-623	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-624	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-625	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-626	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-628	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-629	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current