Dexmethylphenidate Hydrochloride

Product NDC: 49884-339
11-digit product format: 498840339
Labeler code: 49884
Product ID: 49884-339_09fcee97-8b48-4a1d-a380-0e01c92e0e9b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dexmethylphenidate Hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Par Health USA, LLC
Application: ANDA202842
Marketing category: ANDA
Marketing start: 2017-01-05
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
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product	49884-339		I	Inactivated by FDA		excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	49884-339	49884-339-01	I	Inactivated by FDA		excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	TE codes	Approval date
A202842-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30
A202842-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30
A202842-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30
A202842-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30
A202842-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30
A202842-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30
A202842-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30
A202842-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 8 matching rows.

Application-product, TE code table
Application-product	TE code
A202842-001	AB
A202842-002	AB
A202842-003	AB
A202842-004	AB
A202842-005	AB
A202842-006	AB
A202842-007	AB
A202842-008	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 9 · 336 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
2026-08-18 06:07:40	2026-07	A202842-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202842-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202842-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202842-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202842-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202842-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202842-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202842-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202842-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202842-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202842-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202842-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202842-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202842-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202842-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202842-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202842-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202842-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202842-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202842-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202842-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202842-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202842-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202842-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202842-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202842-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202842-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202842-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202842-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202842-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202842-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202842-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202842-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202842-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202842-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202842-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202842-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202842-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202842-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202842-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 9 · 336 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A202842-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202842-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202842-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202842-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202842-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202842-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202842-007	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202842-008	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202842-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202842-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202842-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202842-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202842-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202842-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202842-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202842-008	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202842-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202842-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202842-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202842-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202842-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202842-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202842-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202842-008	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202842-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202842-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202842-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202842-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202842-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202842-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202842-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202842-008	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202842-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202842-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202842-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202842-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202842-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202842-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202842-007	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202842-008	AB	1	`fd3edfee7708…`

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 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
899439	Internal RxNorm lookup
899461	Internal RxNorm lookup
899485	Internal RxNorm lookup
899495	Internal RxNorm lookup
899511	Internal RxNorm lookup
1006608	Internal RxNorm lookup
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
e304388e-86a6-4335-abae-0ce79c7c99c6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49884-339-01	2022-10-05	C162847	48780-1	e4f33bdf-a7e7-d8a0-e053-dadaa90a6e4e	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
49884-339-01	2022-07-29	C162847	48780-1	e4f33bdf-a7e7-d8a0-e053-dadaa90a6e4e	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
49884-339-01	Dexmethylphenidate Hydrochloride	100 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	100		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49884-339-01	EA - Each	49884-339	253ef70c-765d-4ef5-8be7-7059daac9d37	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49884-339	DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ENDO USA, INC.]	12	Current NDC, Legacy NDC, 1 package rows	20250116_e304388e-86a6-4335-abae-0ce79c7c99c6.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 · 12 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	d9c450fa-c8c5-4ff0-a263-4a9eee6f5437	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202842 application number: ANDA202842
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	b64f3622-b3d7-4a1e-9f1f-0ac0fe3dadfe	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202842 application number: ANDA202842
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	b82e8d08-cc4a-40a6-85a5-07717f3cb38b	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202842 application number: ANDA202842
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	b7410d65-9c7f-4ffd-b957-969e2725f38f	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202842 application number: ANDA202842
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	9700cc3d-52e9-40e4-8595-f1c56279a2e0	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202842 application number: ANDA202842
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	6593b3ae-efcc-49ff-ba51-3fb5558605e5	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202842 application number: ANDA202842
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	06bcef7a-b321-4dd8-9bf6-5d8f8940f04a	2024-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202842 application number: ANDA202842
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	a03d8819-a315-4337-ac50-530af98082b0	2024-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202842 application number: ANDA202842
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	424da264-7448-4364-939f-d3ebbee1a6d7	2024-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202842 application number: ANDA202842
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	d3318fec-a1bc-4e3c-86a9-3f00ec296869	2024-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202842 application number: ANDA202842
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	c423a632-e8e0-44a7-a8a8-f66cec81aa64	2024-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202842 application number: ANDA202842
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Par Health USA, LLC	e304388e-86a6-4335-abae-0ce79c7c99c6	2024-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202842 application number: ANDA202842 ndc (product): 49884-339

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
1101932	dexmethylphenidate HCl 35 MG 24HR Extended Release Oral Capsule	PSN	06bcef7a-b321-4dd8-9bf6-5d8f8940f04a	104
1101932	24 HR dexmethylphenidate hydrochloride 35 MG Extended Release Oral Capsule	SCD	06bcef7a-b321-4dd8-9bf6-5d8f8940f04a	104
1101932	dexmethylphenidate hydrochloride 35 MG 24 HR Extended Release Oral Capsule	SY	06bcef7a-b321-4dd8-9bf6-5d8f8940f04a	104
1101932	dexmethylphenidate HCl 35 MG 24HR Extended Release Oral Capsule	PSN	b7410d65-9c7f-4ffd-b957-969e2725f38f	102
1101932	24 HR dexmethylphenidate hydrochloride 35 MG Extended Release Oral Capsule	SCD	b7410d65-9c7f-4ffd-b957-969e2725f38f	102
1101932	dexmethylphenidate hydrochloride 35 MG 24 HR Extended Release Oral Capsule	SY	b7410d65-9c7f-4ffd-b957-969e2725f38f	102
899439	dexmethylphenidate HCl 10 MG 24HR Extended Release Oral Capsule	PSN	e304388e-86a6-4335-abae-0ce79c7c99c6	13
899461	dexmethylphenidate HCl 15 MG 24HR Extended Release Oral Capsule	PSN	e304388e-86a6-4335-abae-0ce79c7c99c6	13
899485	dexmethylphenidate HCl 20 MG 24HR Extended Release Oral Capsule	PSN	e304388e-86a6-4335-abae-0ce79c7c99c6	13
1101926	dexmethylphenidate HCl 25 MG 24HR Extended Release Oral Capsule	PSN	e304388e-86a6-4335-abae-0ce79c7c99c6	13
899495	dexmethylphenidate HCl 30 MG 24HR Extended Release Oral Capsule	PSN	e304388e-86a6-4335-abae-0ce79c7c99c6	13
1101932	dexmethylphenidate HCl 35 MG 24HR Extended Release Oral Capsule	PSN	e304388e-86a6-4335-abae-0ce79c7c99c6	13
1006608	dexmethylphenidate HCl 40 MG 24HR Extended Release Oral Capsule	PSN	e304388e-86a6-4335-abae-0ce79c7c99c6	13
899511	dexmethylphenidate HCl 5 MG 24HR Extended Release Oral Capsule	PSN	e304388e-86a6-4335-abae-0ce79c7c99c6	13
899439	24 HR dexmethylphenidate hydrochloride 10 MG Extended Release Oral Capsule	SCD	e304388e-86a6-4335-abae-0ce79c7c99c6	13
899461	24 HR dexmethylphenidate hydrochloride 15 MG Extended Release Oral Capsule	SCD	e304388e-86a6-4335-abae-0ce79c7c99c6	13
899485	24 HR dexmethylphenidate hydrochloride 20 MG Extended Release Oral Capsule	SCD	e304388e-86a6-4335-abae-0ce79c7c99c6	13
1101926	24 HR dexmethylphenidate hydrochloride 25 MG Extended Release Oral Capsule	SCD	e304388e-86a6-4335-abae-0ce79c7c99c6	13
899495	24 HR dexmethylphenidate hydrochloride 30 MG Extended Release Oral Capsule	SCD	e304388e-86a6-4335-abae-0ce79c7c99c6	13
1101932	24 HR dexmethylphenidate hydrochloride 35 MG Extended Release Oral Capsule	SCD	e304388e-86a6-4335-abae-0ce79c7c99c6	13
1006608	24 HR dexmethylphenidate hydrochloride 40 MG Extended Release Oral Capsule	SCD	e304388e-86a6-4335-abae-0ce79c7c99c6	13
899511	24 HR dexmethylphenidate hydrochloride 5 MG Extended Release Oral Capsule	SCD	e304388e-86a6-4335-abae-0ce79c7c99c6	13
899439	dexmethylphenidate hydrochloride 10 MG 24 HR Extended Release Oral Capsule	SY	e304388e-86a6-4335-abae-0ce79c7c99c6	13
899461	dexmethylphenidate hydrochloride 15 MG 24 HR Extended Release Oral Capsule	SY	e304388e-86a6-4335-abae-0ce79c7c99c6	13
899485	dexmethylphenidate hydrochloride 20 MG 24 HR Extended Release Oral Capsule	SY	e304388e-86a6-4335-abae-0ce79c7c99c6	13
1101926	dexmethylphenidate hydrochloride 25 MG 24 HR Extended Release Oral Capsule	SY	e304388e-86a6-4335-abae-0ce79c7c99c6	13
899495	dexmethylphenidate hydrochloride 30 MG 24 HR Extended Release Oral Capsule	SY	e304388e-86a6-4335-abae-0ce79c7c99c6	13
1101932	dexmethylphenidate hydrochloride 35 MG 24 HR Extended Release Oral Capsule	SY	e304388e-86a6-4335-abae-0ce79c7c99c6	13
1006608	dexmethylphenidate hydrochloride 40 MG 24 HR Extended Release Oral Capsule	SY	e304388e-86a6-4335-abae-0ce79c7c99c6	13
899511	dexmethylphenidate hydrochloride 5 MG 24 HR Extended Release Oral Capsule	SY	e304388e-86a6-4335-abae-0ce79c7c99c6	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
49884-339-01	49884033901	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (49884-339-01)	2017-01-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	2024-08-12	HUMAN PRESCRIPTION DRUG LABEL	102
Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	2024-08-08	HUMAN PRESCRIPTION DRUG LABEL	104
Dexmethylphenidate Hydrochloride	Par Health USA, LLC	2024-01-31	HUMAN PRESCRIPTION DRUG LABEL	13