Dexmethylphenidate hydrochloride

Product NDC: 0115-1710
11-digit product format: 001151710
Labeler code: 0115
Product ID: 0115-1710_b9254c68-2d68-4a6d-874b-d85a32ce4893
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dexmethylphenidate hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Amneal Pharmaceuticals of New York LLC
Application: ANDA203614
Marketing category: ANDA
Marketing start: 2017-07-05
Substance: DEXMETHYLPHENIDATE HYDROCHLORIDE
Active strength: 35 mg/1
Pharmacologic classes: Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product	0115-1710		I	Inactivated by FDA		excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0115-1710	0115-1710-01	I	Inactivated by FDA		excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203614-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-07-05
A203614-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-07-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A203614-001	AB
A203614-002	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 3 · 82 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	A203614-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203614-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203614-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203614-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203614-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203614-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203614-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203614-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203614-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203614-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203614-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203614-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203614-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203614-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203614-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203614-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203614-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203614-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203614-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203614-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203614-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203614-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203614-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203614-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203614-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203614-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203614-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203614-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203614-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203614-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203614-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203614-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203614-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203614-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203614-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203614-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203614-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203614-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203614-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203614-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203614-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203614-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203614-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203614-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203614-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203614-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203614-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203614-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203614-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203614-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203614-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203614-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203614-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203614-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203614-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203614-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203614-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203614-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203614-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203614-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203614-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203614-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203614-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203614-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203614-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203614-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203614-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203614-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203614-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203614-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203614-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203614-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203614-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203614-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203614-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203614-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203614-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203614-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203614-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203614-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Dexmethylphenidate hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXMETHYLPHENIDATE HYDROCHLORIDE	35 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1678OK0E08	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1101926	Internal RxNorm lookup
1101932	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
be7019d7-eb3e-48eb-b6ba-0ffefae6dcd0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1ff349b0-f325-4585-9c0d-7dc58eb1bc1b	Product name	1	20210818
7d5b6b15-5a1e-e1e5-992d-90d0701572ad	Product name	9	20210511
ccfbb2ac-2915-4b21-1d79-8a93f773e70f	Product name	9	20200714

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2020-12-29	These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 2005
2020-12-29	These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 2005
2020-09-27	These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 2005
2020-09-27	These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 2005
2020-09-25	These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 2005
2020-09-25	These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 2005
2020-07-22	These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 2005
2020-07-22	These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 2005

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0115-1710-01	Dexmethylphenidate hydrochloride	100 in 1 BOTTLE, PLASTIC	CAPSULE, EXTENDED RELEASE	100		22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0115-1710-01	EA - Each	0115-1710	0eba2ce4-804c-4ff6-91bf-d7ef8fe7a762	1	2017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0115-1710	DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]	21	Current NDC, Legacy NDC, 1 package rows	20240919_be7019d7-eb3e-48eb-b6ba-0ffefae6dcd0.zip

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	Amneal Pharmaceuticals of New York LLC	be7019d7-eb3e-48eb-b6ba-0ffefae6dcd0	2025-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203614 application number: ANDA203614 ndc (product): 0115-1710

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1101926	dexmethylphenidate HCl 25 MG 24HR Extended Release Oral Capsule	PSN	be7019d7-eb3e-48eb-b6ba-0ffefae6dcd0	22
1101932	dexmethylphenidate HCl 35 MG 24HR Extended Release Oral Capsule	PSN	be7019d7-eb3e-48eb-b6ba-0ffefae6dcd0	22
1101926	24 HR dexmethylphenidate hydrochloride 25 MG Extended Release Oral Capsule	SCD	be7019d7-eb3e-48eb-b6ba-0ffefae6dcd0	22
1101932	24 HR dexmethylphenidate hydrochloride 35 MG Extended Release Oral Capsule	SCD	be7019d7-eb3e-48eb-b6ba-0ffefae6dcd0	22
1101926	dexmethylphenidate hydrochloride 25 MG 24 HR Extended Release Oral Capsule	SY	be7019d7-eb3e-48eb-b6ba-0ffefae6dcd0	22
1101932	dexmethylphenidate hydrochloride 35 MG 24 HR Extended Release Oral Capsule	SY	be7019d7-eb3e-48eb-b6ba-0ffefae6dcd0	22

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0115-1710-01	00115171001	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0115-1710-01)	2017-07-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	2025-10-09	HUMAN PRESCRIPTION DRUG LABEL	22