Dexmethylphenidate Hydrochloride

Product NDC: 49884-430
11-digit product format: 498840430
Labeler code: 49884
Product ID: 49884-430_47a67542-0c06-4542-e063-6394a90a8bfe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dexmethylphenidate Hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Par Health USA, LLC
Application: ANDA078992
Marketing category: ANDA
Marketing start: 2013-11-19
Substance: DEXMETHYLPHENIDATE HYDROCHLORIDE
Active strength: 30 mg/1
Pharmacologic classes: Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 12 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	49884-430-10	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	49884-430-01	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	49884-430-10	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	49884-430-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	49884-430-10	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	49884-430-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	49884-430-10	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	49884-430-01	`bd6a592717d7…`	`303034d00443…`

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078992-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-11-23
A078992-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-11-23
A078992-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-18
A078992-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-18
A078992-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-11-23
A078992-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-11-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A078992-001	AB
A078992-002	AB
A078992-003	AB
A078992-004	AB
A078992-005	AB
A078992-006	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 6 · 220 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	A078992-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078992-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078992-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078992-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078992-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078992-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-11-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078992-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078992-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078992-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078992-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078992-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078992-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-11-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078992-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078992-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078992-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078992-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078992-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078992-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-11-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078992-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078992-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078992-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078992-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078992-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078992-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-11-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078992-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078992-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078992-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078992-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078992-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078992-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-11-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078992-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078992-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078992-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078992-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078992-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078992-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-11-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078992-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078992-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078992-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078992-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-18	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 220 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	A078992-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078992-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078992-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078992-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078992-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078992-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078992-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078992-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078992-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078992-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078992-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078992-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078992-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078992-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078992-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078992-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078992-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078992-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078992-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078992-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078992-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078992-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078992-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078992-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078992-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078992-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078992-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078992-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078992-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078992-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078992-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078992-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078992-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078992-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078992-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078992-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078992-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078992-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078992-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078992-004	AB	1	`03ed91905a0d…`

Additional Listing Data#

Finished product: Yes
Brand name base: Dexmethylphenidate Hydrochloride
Brand name suffix: Extended-Release
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXMETHYLPHENIDATE HYDROCHLORIDE	30 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
899461	Internal RxNorm lookup
899495	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
4ed9f3c8-c71f-499e-bb91-c19847bf4444	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#

NDC, Effective, Related label table
NDC	Effective	Related label
49884-430-01	2024-04-21	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
49884-430-10	2024-04-21	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
49884-430-01	2022-01-28	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
49884-430-10	2022-01-28	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
49884-430-01	Dexmethylphenidate HydrochlorideExtended-Release	100 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	100		22
49884-430-10	Dexmethylphenidate HydrochlorideExtended-Release	1000 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	1000		22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49884-430-01	EA - Each	49884-430	703129bd-61fe-4f9e-ad0f-47c30487b623	1	2013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXMETHYLPHENIDATE HYDROCHLORIDE	ACTIVE INGREDIENT	1678OK0E08	DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL INC.]	5
DEXMETHYLPHENIDATE	ACTIVE MOIETY	M32RH9MFGP	DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL INC.]	5
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL INC.]	5
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL INC.]	5
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL INC.]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL INC.]	5
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	INACTIVE INGREDIENT	74G4R6TH13	DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL INC.]	5
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)	INACTIVE INGREDIENT	5KY68S2577	DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL INC.]	5
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL INC.]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL INC.]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL INC.]	5
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL INC.]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL INC.]	5
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL INC.]	5
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49884-430	DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICALS, INC.]	21	Current NDC, Legacy NDC, 2 package rows	20240423_4ed9f3c8-c71f-499e-bb91-c19847bf4444.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexmethylphenidate Hydrochloride Extended-Release	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	bb4f32eb-05c7-449e-8e5a-f45781a58f70	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078992 application number: ANDA078992
Dexmethylphenidate Hydrochloride Extended-Release	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	72d7a084-79cf-44c5-a158-fae1fc2faba4	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078992 application number: ANDA078992
Dexmethylphenidate Hydrochloride Extended-Release	DEXMETHYLPHENIDATE HYDROCHLORIDE	Par Health USA, LLC	4ed9f3c8-c71f-499e-bb91-c19847bf4444	2026-01-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078992 application number: ANDA078992 ndc (product): 49884-430
Dexmethylphenidate Hydrochloride Extended-Release	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	a0133bf5-3cb3-4405-a007-43fbcf957333	2024-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078992 application number: ANDA078992
Dexmethylphenidate Hydrochloride Extended-Release	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	32b3c189-f0f8-4f3e-87da-ce56f583fc42	2024-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078992 application number: ANDA078992

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
899495	dexmethylphenidate HCl 30 MG 24HR Extended Release Oral Capsule	PSN	72d7a084-79cf-44c5-a158-fae1fc2faba4	104
899495	dexmethylphenidate HCl 30 MG 24HR Extended Release Oral Capsule	PSN	a0133bf5-3cb3-4405-a007-43fbcf957333	104
899495	24 HR dexmethylphenidate hydrochloride 30 MG Extended Release Oral Capsule	SCD	72d7a084-79cf-44c5-a158-fae1fc2faba4	104
899495	24 HR dexmethylphenidate hydrochloride 30 MG Extended Release Oral Capsule	SCD	a0133bf5-3cb3-4405-a007-43fbcf957333	104
899495	dexmethylphenidate hydrochloride 30 MG 24 HR Extended Release Oral Capsule	SY	72d7a084-79cf-44c5-a158-fae1fc2faba4	104
899495	dexmethylphenidate hydrochloride 30 MG 24 HR Extended Release Oral Capsule	SY	a0133bf5-3cb3-4405-a007-43fbcf957333	104
899461	dexmethylphenidate HCl 15 MG 24HR Extended Release Oral Capsule	PSN	4ed9f3c8-c71f-499e-bb91-c19847bf4444	22
899495	dexmethylphenidate HCl 30 MG 24HR Extended Release Oral Capsule	PSN	4ed9f3c8-c71f-499e-bb91-c19847bf4444	22
899461	24 HR dexmethylphenidate hydrochloride 15 MG Extended Release Oral Capsule	SCD	4ed9f3c8-c71f-499e-bb91-c19847bf4444	22
899495	24 HR dexmethylphenidate hydrochloride 30 MG Extended Release Oral Capsule	SCD	4ed9f3c8-c71f-499e-bb91-c19847bf4444	22
899461	dexmethylphenidate hydrochloride 15 MG 24 HR Extended Release Oral Capsule	SY	4ed9f3c8-c71f-499e-bb91-c19847bf4444	22
899495	dexmethylphenidate hydrochloride 30 MG 24 HR Extended Release Oral Capsule	SY	4ed9f3c8-c71f-499e-bb91-c19847bf4444	22

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
49884-430-01	49884043001	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (49884-430-01)	2013-11-19	0000-00-00	No	No	Current
49884-430-10	49884043010	1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (49884-430-10)	2013-11-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dexmethylphenidate Hydrochloride Extended-Release	Bryant Ranch Prepack	2026-03-31	HUMAN PRESCRIPTION DRUG LABEL	104
Dexmethylphenidate Hydrochloride Extended-Release	Par Health USA, LLC	2026-01-05	HUMAN PRESCRIPTION DRUG LABEL	22
Dexmethylphenidate Hydrochloride Extended-Release	Bryant Ranch Prepack	2024-05-30	HUMAN PRESCRIPTION DRUG LABEL	104