Application 212631

Type: ANDA
Sponsor: ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	TABLET;ORAL	2.5MG	No	No
002	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
003	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A212631-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2019-07-19
A212631-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-07-19
A212631-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-07-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212631-001	AB
A212631-002	AB
A212631-003	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 · 126 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	A212631-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212631-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212631-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212631-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212631-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212631-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212631-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212631-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212631-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212631-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212631-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212631-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212631-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212631-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212631-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212631-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2019-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212631-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212631-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-07-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212631-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2019-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212631-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212631-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-07-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212631-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2019-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212631-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212631-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-07-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212631-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2019-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212631-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212631-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-07-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212631-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2019-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212631-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212631-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-07-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212631-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2019-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212631-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212631-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-07-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212631-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2019-07-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212631-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-07-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212631-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-07-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212631-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2019-07-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212631-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-07-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212631-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-07-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212631-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2019-07-19	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 4 · 126 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	A212631-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A212631-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A212631-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A212631-003	AB	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212631-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212631-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212631-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212631-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A212631-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A212631-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212631-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A212631-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A212631-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212631-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212631-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212631-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212631-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212631-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212631-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212631-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212631-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212631-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212631-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212631-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212631-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212631-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A212631-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A212631-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212631-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A212631-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A212631-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212631-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212631-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212631-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212631-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A212631-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A212631-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212631-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A212631-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A212631-003	AB	1	`e64feba35796…`

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
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Ascend Laboratories, LLC	830df993-db01-40df-beef-90af6b86f561	2024-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212631 application number: ANDA212631 ndc (product): 67877-655 ndc (product): 67877-656 ndc (product): 67877-657

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63629-9467	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-9468	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-9469	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
67877-655	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-655	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-655	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-656	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-656	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-656	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-657	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-657	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-657	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Ascend Laboratories, LLC	ANDA	Current