Dexmethylphenidate Hydrochloride

Product NDC: 0527-1899
11-digit product format: 005271899
Labeler code: 0527
Product ID: 0527-1899_0c69f111-f3c3-4ecb-a8ae-05c5531632db
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dexmethylphenidate Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Lannett Company, Inc.
Application: ANDA209468
Marketing category: ANDA
Marketing start: 2017-09-25
Marketing end: 0000-00-00
Substance: DEXMETHYLPHENIDATE HYDROCHLORIDE
Active strength: 3 mg/1
Pharmacologic classes: Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0527-1899		D	Discontinued by firm		2026-10-30
excluded package	package	0527-1899	0527-1899-01	D	Discontinued by firm		2026-10-30

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 28 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0527-1899-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0527-1899-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0527-1899-01	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0527-1899-01	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0527-1899-01	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0527-1899-01	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0527-1899-01	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0527-1899-01	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0527-1899-01	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0527-1899-01	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	0527-1899-01	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	0527-1899-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	0527-1899-01	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0527-1899-01	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A209468-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2017-09-25
A209468-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2017-09-25
A209468-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2017-09-25

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 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A209468-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2017-09-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A209468-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2017-09-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A209468-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2017-09-25	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A209468-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2017-09-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209468-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2017-09-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209468-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2017-09-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209468-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2017-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209468-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2017-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209468-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2017-09-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209468-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2017-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209468-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2017-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209468-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2017-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209468-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2017-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209468-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2017-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209468-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2017-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209468-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2017-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209468-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2017-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209468-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2017-09-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209468-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2017-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209468-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2017-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209468-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2017-09-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209468-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2017-09-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209468-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2017-09-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209468-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2017-09-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209468-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2017-09-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209468-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2017-09-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209468-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2017-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209468-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2017-09-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209468-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2017-09-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209468-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2017-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209468-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2017-09-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209468-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2017-09-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209468-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2017-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209468-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2017-09-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209468-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2017-09-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209468-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2017-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209468-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2017-09-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209468-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2017-09-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209468-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2017-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209468-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2017-09-25	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A209468-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209468-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209468-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A209468-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A209468-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A209468-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209468-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A209468-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A209468-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209468-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A209468-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A209468-003	AB	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2023-07-27	These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS. DEXMETHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 2001
2020-09-27	These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS. DEXMETHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 2001
2020-09-25	These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS. DEXMETHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 2001
2020-07-22	These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS. DEXMETHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 2001

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1678OK0E08	DEXMETHYLPHENIDATE HYDROCHLORIDE	19262-68-1	DEXMETHYLPHENIDATE HYDROCHLORIDE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dexmethylphenidate Hydrochloride	Lannett Company, Inc.	2023-07-26	HUMAN PRESCRIPTION DRUG LABEL	14