methylphenidate Hydrochloride

Product NDC: 10147-0685
11-digit product format: 101470685
Labeler code: 10147
Product ID: 10147-0685_5e2dbcde-b6a2-11ec-9a3d-d90cfed203d4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methylphenidate hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Patriot Pharmaceuticals, LLC.
Application: NDA021121
Marketing category: NDA
Marketing start: 2000-08-01
Marketing end: 0000-00-00
Substance: METHYLPHENIDATE HYDROCHLORIDE
Active strength: 18 mg/1
Pharmacologic classes: Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	10147-0685		D	Discontinued by firm		2026-08-07
excluded package	package	10147-0685	10147-0685-1	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 · 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10147-0685	10147-0685-1	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10147-0685	10147-0685-1	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
10147-0685-1	EA - Each	10147-0685	06a23e7c-3a1f-4e25-b90b-24c07cfbd3aa	1	2019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10147-0685	METHYLPHENIDATE HYDROCHLORIDE TABLET [PATRIOT PHARMACEUTICALS, LLC.]	10	Legacy NDC	20231130_dad446b7-b26c-44f2-9e30-4cbd10d8b23c.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
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
10147-0685-1	10147068501	100 TABLET in 1 BOTTLE (10147-0685-1)	100 tablet	2019-02-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
methylphenidate Hydrochloride	Patriot Pharmaceuticals, LLC. \| AndersonBrecon Inc. \| Janssen Pharmaceutica Inc \| Janssen Pharmaceutica Inc. \| Janssen Ortho, LLC \| Janssen-Cilag Manufacturing, LLC	2025-08-05	HUMAN PRESCRIPTION DRUG LABEL	11