Dexmethylphenidate Hydrochloride

Product NDC: 0093-5553
Requested package NDC: 0093-5553-01
11-digit product format: 000935553
Labeler code: 0093
Product ID: 0093-5553_ee2dd90b-be3b-4649-b6f8-91468a37b1a5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dexmethylphenidate Hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA078908
Marketing category: ANDA
Marketing start: 2015-06-22
Substance: DEXMETHYLPHENIDATE HYDROCHLORIDE
Active strength: 20 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

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078908-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-19
A078908-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-19
A078908-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-19
A078908-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2014-05-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A078908-001	AB
A078908-002	AB
A078908-003	AB
A078908-004	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 5 · 164 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	A078908-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078908-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078908-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078908-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2014-05-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078908-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078908-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078908-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078908-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2014-05-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078908-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078908-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078908-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078908-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2014-05-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078908-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078908-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078908-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078908-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2014-05-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078908-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078908-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078908-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078908-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2014-05-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078908-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078908-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078908-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078908-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2014-05-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078908-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078908-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078908-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078908-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2014-05-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078908-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078908-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078908-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078908-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2014-05-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078908-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078908-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078908-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078908-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2014-05-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078908-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078908-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078908-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-11-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078908-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2014-05-19	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A078908-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078908-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078908-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078908-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078908-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078908-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078908-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078908-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078908-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078908-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078908-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078908-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078908-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078908-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078908-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078908-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078908-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078908-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078908-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078908-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078908-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078908-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078908-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078908-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078908-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078908-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078908-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078908-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078908-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078908-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078908-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078908-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078908-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078908-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078908-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078908-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078908-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078908-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078908-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078908-004	AB	1	`d06236e962d9…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXMETHYLPHENIDATE HYDROCHLORIDE	20 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
dd659d39-41f5-4612-8f17-bad602b4784d	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0093-5553-01	Dexmethylphenidate Hydrochloride	100 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	100		23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-5553-01	EA - Each	0093-5553	33a17653-555d-4172-9202-fc6f47ba9c4d	1	2015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXMETHYLPHENIDATE HYDROCHLORIDE	ACTIVE INGREDIENT	1678OK0E08	DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	5
DEXMETHYLPHENIDATE	ACTIVE MOIETY	M32RH9MFGP	DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	5
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	5
AMMONIO METHACRYLATE COPOLYMER TYPE B	INACTIVE INGREDIENT	161H3B14U2	DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	5
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	5
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	5
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	5
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	5
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	5
HYPROMELLOSE 2208 (3 MPA.S)	INACTIVE INGREDIENT	9H4L916OBU	DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	5
INDIGOTINDISULFONATE SODIUM	INACTIVE INGREDIENT	D3741U8K7L	DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	5
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	INACTIVE INGREDIENT	74G4R6TH13	DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	5
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	5
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	5
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	5
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	5
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0093-5553	DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA, INC.]	21	Current NDC, Legacy NDC, 1 package rows	20250523_dd659d39-41f5-4612-8f17-bad602b4784d.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	Teva Pharmaceuticals USA, Inc.	dd659d39-41f5-4612-8f17-bad602b4784d	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078908 application number: ANDA078908 ndc (package): 0093-5553-01 ndc (product): 0093-5553 ndc11 (package): 00093555301

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
899439	dexmethylphenidate HCl 10 MG 24HR Extended Release Oral Capsule	PSN	dd659d39-41f5-4612-8f17-bad602b4784d	23
899461	dexmethylphenidate HCl 15 MG 24HR Extended Release Oral Capsule	PSN	dd659d39-41f5-4612-8f17-bad602b4784d	23
899485	dexmethylphenidate HCl 20 MG 24HR Extended Release Oral Capsule	PSN	dd659d39-41f5-4612-8f17-bad602b4784d	23
1101926	dexmethylphenidate HCl 25 MG 24HR Extended Release Oral Capsule	PSN	dd659d39-41f5-4612-8f17-bad602b4784d	23
899495	dexmethylphenidate HCl 30 MG 24HR Extended Release Oral Capsule	PSN	dd659d39-41f5-4612-8f17-bad602b4784d	23
1101932	dexmethylphenidate HCl 35 MG 24HR Extended Release Oral Capsule	PSN	dd659d39-41f5-4612-8f17-bad602b4784d	23
1006608	dexmethylphenidate HCl 40 MG 24HR Extended Release Oral Capsule	PSN	dd659d39-41f5-4612-8f17-bad602b4784d	23
899511	dexmethylphenidate HCl 5 MG 24HR Extended Release Oral Capsule	PSN	dd659d39-41f5-4612-8f17-bad602b4784d	23
899439	24 HR dexmethylphenidate hydrochloride 10 MG Extended Release Oral Capsule	SCD	dd659d39-41f5-4612-8f17-bad602b4784d	23
899461	24 HR dexmethylphenidate hydrochloride 15 MG Extended Release Oral Capsule	SCD	dd659d39-41f5-4612-8f17-bad602b4784d	23
899485	24 HR dexmethylphenidate hydrochloride 20 MG Extended Release Oral Capsule	SCD	dd659d39-41f5-4612-8f17-bad602b4784d	23
1101926	24 HR dexmethylphenidate hydrochloride 25 MG Extended Release Oral Capsule	SCD	dd659d39-41f5-4612-8f17-bad602b4784d	23
899495	24 HR dexmethylphenidate hydrochloride 30 MG Extended Release Oral Capsule	SCD	dd659d39-41f5-4612-8f17-bad602b4784d	23
1101932	24 HR dexmethylphenidate hydrochloride 35 MG Extended Release Oral Capsule	SCD	dd659d39-41f5-4612-8f17-bad602b4784d	23
1006608	24 HR dexmethylphenidate hydrochloride 40 MG Extended Release Oral Capsule	SCD	dd659d39-41f5-4612-8f17-bad602b4784d	23
899511	24 HR dexmethylphenidate hydrochloride 5 MG Extended Release Oral Capsule	SCD	dd659d39-41f5-4612-8f17-bad602b4784d	23
899439	dexmethylphenidate hydrochloride 10 MG 24 HR Extended Release Oral Capsule	SY	dd659d39-41f5-4612-8f17-bad602b4784d	23
899461	dexmethylphenidate hydrochloride 15 MG 24 HR Extended Release Oral Capsule	SY	dd659d39-41f5-4612-8f17-bad602b4784d	23
899485	dexmethylphenidate hydrochloride 20 MG 24 HR Extended Release Oral Capsule	SY	dd659d39-41f5-4612-8f17-bad602b4784d	23
1101926	dexmethylphenidate hydrochloride 25 MG 24 HR Extended Release Oral Capsule	SY	dd659d39-41f5-4612-8f17-bad602b4784d	23
899495	dexmethylphenidate hydrochloride 30 MG 24 HR Extended Release Oral Capsule	SY	dd659d39-41f5-4612-8f17-bad602b4784d	23
1101932	dexmethylphenidate hydrochloride 35 MG 24 HR Extended Release Oral Capsule	SY	dd659d39-41f5-4612-8f17-bad602b4784d	23
1006608	dexmethylphenidate hydrochloride 40 MG 24 HR Extended Release Oral Capsule	SY	dd659d39-41f5-4612-8f17-bad602b4784d	23
899511	dexmethylphenidate hydrochloride 5 MG 24 HR Extended Release Oral Capsule	SY	dd659d39-41f5-4612-8f17-bad602b4784d	23

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0093-5553-01	00093555301	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-5553-01)	2015-06-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dexmethylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	2026-07-08	HUMAN PRESCRIPTION DRUG LABEL	24