methylphenidate hydrochloride

Product NDC: 0591-2718
Requested package NDC: 0591-2718-01
11-digit product format: 005912718
Labeler code: 0591
Product ID: 0591-2718_6b2dcacd-6280-421e-8ac2-ac00db79a5d5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methylphenidate hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: NDA021121
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2011-04-01
Marketing end: 2021-09-30
Substance: METHYLPHENIDATE HYDROCHLORIDE
Active strength: 54 mg/1
Pharmacologic classes: Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0591-2718	0591-2718-01	D	Discontinued by firm		2026-08-07

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, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	RLD / RS	Approval date
N021121-001	CONCERTA	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01
N021121-002	CONCERTA	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01
N021121-003	CONCERTA	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-08
N021121-004	CONCERTA	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-04-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021121-001	AB
N021121-002	AB
N021121-003	AB
N021121-004	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021121-001	CONCERTA	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021121-002	CONCERTA	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021121-003	CONCERTA	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021121-004	CONCERTA	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-04-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021121-001	CONCERTA	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021121-002	CONCERTA	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021121-003	CONCERTA	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021121-004	CONCERTA	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-04-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021121-001	CONCERTA	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021121-002	CONCERTA	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021121-003	CONCERTA	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021121-004	CONCERTA	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-04-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021121-001	CONCERTA	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021121-002	CONCERTA	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021121-003	CONCERTA	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021121-004	CONCERTA	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-04-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021121-001	CONCERTA	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021121-002	CONCERTA	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021121-003	CONCERTA	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021121-004	CONCERTA	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-04-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021121-001	CONCERTA	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021121-002	CONCERTA	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021121-003	CONCERTA	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021121-004	CONCERTA	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-04-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021121-001	CONCERTA	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021121-002	CONCERTA	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021121-003	CONCERTA	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021121-004	CONCERTA	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-04-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021121-001	CONCERTA	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021121-002	CONCERTA	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021121-003	CONCERTA	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021121-004	CONCERTA	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-04-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021121-001	CONCERTA	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021121-002	CONCERTA	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021121-003	CONCERTA	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021121-004	CONCERTA	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-04-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021121-001	CONCERTA	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021121-002	CONCERTA	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021121-003	CONCERTA	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021121-004	CONCERTA	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-04-01	`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	N021121-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021121-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021121-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021121-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021121-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021121-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021121-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021121-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021121-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021121-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021121-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021121-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021121-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021121-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021121-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021121-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021121-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021121-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021121-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021121-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021121-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021121-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021121-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021121-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021121-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021121-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021121-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021121-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021121-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021121-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021121-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021121-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021121-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021121-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021121-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021121-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021121-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021121-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021121-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021121-004	AB	1	`d06236e962d9…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-2718-01	EA - Each	0591-2718	0b89e280-16cf-46d6-90f6-39a11b47fc8c	1	2012-07-24
0591-2718-30	EA - Each	0591-2718	b9ce281c-57bf-4f4e-ad2c-8e567baa6154	1	2014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
methylphenidate hydrochloride	ACTIVE INGREDIENT	4B3SC438HI	METHYLPHENIDATE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]	10
methylphenidate	ACTIVE MOIETY	207ZZ9QZ49	METHYLPHENIDATE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]	10
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	METHYLPHENIDATE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]	10
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	METHYLPHENIDATE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]	10
cellulose acetate	INACTIVE INGREDIENT	3J2P07GVB6	METHYLPHENIDATE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]	10
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	METHYLPHENIDATE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]	10
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	METHYLPHENIDATE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]	10
lactose	INACTIVE INGREDIENT	J2B2A4N98G	METHYLPHENIDATE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]	10
phosphoric acid	INACTIVE INGREDIENT	E4GA8884NN	METHYLPHENIDATE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]	10
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	METHYLPHENIDATE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]	10
povidones	INACTIVE INGREDIENT	FZ989GH94E	METHYLPHENIDATE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]	10
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	METHYLPHENIDATE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]	10
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	METHYLPHENIDATE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]	10
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	METHYLPHENIDATE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]	10
succinic acid	INACTIVE INGREDIENT	AB6MNQ6J6L	METHYLPHENIDATE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]	10
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	METHYLPHENIDATE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]	10
triacetin	INACTIVE INGREDIENT	XHX3C3X673	METHYLPHENIDATE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]	10
methylphenidate hydrochloride	ACTIVE INGREDIENT	4B3SC438HI	METHYLPHENIDATE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	2
methylphenidate	ACTIVE MOIETY	207ZZ9QZ49	METHYLPHENIDATE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	2
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	METHYLPHENIDATE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	2
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	METHYLPHENIDATE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	2
cellulose acetate	INACTIVE INGREDIENT	3J2P07GVB6	METHYLPHENIDATE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	2
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	METHYLPHENIDATE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	2
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	METHYLPHENIDATE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	2
lactose	INACTIVE INGREDIENT	J2B2A4N98G	METHYLPHENIDATE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	2
phosphoric acid	INACTIVE INGREDIENT	E4GA8884NN	METHYLPHENIDATE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	2
POLOXAMER 124	INACTIVE INGREDIENT	1S66E28KXA	METHYLPHENIDATE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	2
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	METHYLPHENIDATE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	2
povidones	INACTIVE INGREDIENT	FZ989GH94E	METHYLPHENIDATE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	2
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	METHYLPHENIDATE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	2
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	METHYLPHENIDATE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	2
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	METHYLPHENIDATE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	2
succinic acid	INACTIVE INGREDIENT	AB6MNQ6J6L	METHYLPHENIDATE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	2
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	METHYLPHENIDATE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	2
triacetin	INACTIVE INGREDIENT	XHX3C3X673	METHYLPHENIDATE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	2

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
CONCERTA	METHYLPHENIDATE HYDROCHLORIDE	Janssen Pharmaceuticals, Inc.	1a88218c-5b18-4220-8f56-526de1a276cd	2026-04-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021121 application number: NDA021121

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4B3SC438HI	METHYLPHENIDATE HYDROCHLORIDE	23655-65-4	METHYLPHENIDATE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0591-2718-01	00591271801	100 TABLET in 1 BOTTLE (0591-2718-01)	100 tablet	2011-04-01	2021-09-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
methylphenidate hydrochloride	Actavis Pharma, Inc. \| Alza Corporation \| Janssen Ortho, LLC \| Janssen Pharmaceuticals, Inc. \| AndersonBrecon Inc.	2021-07-14	HUMAN PRESCRIPTION DRUG LABEL	14
methylphenidate hydrochloride	American Health Packaging	2019-10-17	HUMAN PRESCRIPTION DRUG LABEL	5