Methylphenidate Hydrochloride

Product NDC: 63629-1919
11-digit product format: 636291919
Labeler code: 63629
Product ID: 63629-1919_73ad9601-6bbc-43e3-8761-436f30898686
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methylphenidate Hydrochloride
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA210354
Marketing category: ANDA
Marketing start: 2018-03-01
Marketing end: 0000-00-00
Substance: METHYLPHENIDATE HYDROCHLORIDE
Active strength: 10 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	63629-1919		D	Discontinued by firm		2026-10-05
excluded package	package	63629-1919	63629-1919-1	D	Discontinued by firm		2026-10-05

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210354-001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29
A210354-002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29
A210354-003	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	AB	RS	2017-12-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A210354-001	AB
A210354-002	AB
A210354-003	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 4 · 129 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
2026-09-14 22:38:34	2026-08	A210354-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210354-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210354-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	AB	RS	2017-12-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210354-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210354-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210354-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	AB	RS	2017-12-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210354-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210354-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210354-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	AB	RS	2017-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210354-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210354-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210354-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	AB	RS	2017-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210354-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210354-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210354-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	AB	RS	2017-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210354-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210354-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210354-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	AB	RS	2017-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210354-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210354-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210354-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	AB	RS	2017-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210354-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210354-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210354-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	AB	RS	2017-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210354-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210354-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210354-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	AB	RS	2017-12-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210354-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210354-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210354-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	AB	RS	2017-12-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210354-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210354-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210354-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	AB	RS	2017-12-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210354-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210354-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210354-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	AB	RS	2017-12-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210354-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210354-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210354-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	AB	RS	2017-12-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210354-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A210354-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210354-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210354-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210354-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210354-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210354-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210354-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210354-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210354-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210354-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210354-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210354-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210354-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210354-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210354-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210354-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210354-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210354-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210354-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210354-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210354-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210354-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210354-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210354-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210354-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210354-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210354-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210354-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210354-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210354-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210354-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210354-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210354-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210354-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210354-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210354-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210354-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210354-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210354-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210354-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
143536be-f21a-464c-bc5a-163f5c171815	Product name	2	20250626
fd4d0878-dcea-3832-288e-e3bbbbe580ff	Product name	9	20240516
435f0341-cf24-41d5-8fbf-c909821e5596	Product name	1	20230313
c9b6eabb-08d7-bb2d-e81a-06be3590b436	Product name	2	20221216
67aa32c6-44f4-50de-64dd-643e8caf420d	Product name	6	20210622
50b24f34-96fa-4f1e-b262-b0baf4a4a440	Product name	4	20210513
cf83c421-eebe-4de2-b1a2-fd96e3dbfcf8	Product name	1	20200128
166d1d2d-dd55-4fdf-82e2-b83a3c5347c1	Product name	1	20190828
343a61d5-785d-cc27-a43a-0779da054d88	Product name	3	20190828
7607489b-cd15-3103-f3b1-d4283574d250	Product name	2	20190614
407f0cce-da29-4050-a512-2cabe9e5692d	Product name	9	20190611
f7f4bf1e-7c67-46c6-8c42-9beb1a06b38e	Product name	2	20190415
190572d9-6c7b-4b40-8172-c1b5f802c20f	Product name	1	20180724
2948856e-f76e-d380-d9ed-b317efafbc98	Product name	5	20180423
c0aa09de-7aa1-4a98-8f70-62ec3c97c695	Product name	1	20170803
3317aade-2d6e-f159-9fe6-e8385a825178	Product name	3	20160829
0fe52203-83a7-4fed-a91f-8e47a22cf1d3	Product name	1	20160111

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63629-1919-1	Methylphenidate Hydrochloride	100 in 1 BOTTLE	TABLET, CHEWABLE	100		103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-1919-1	EA - Each	63629-1919	81ac40bd-ff46-433f-8acc-2f1ea10da51d	1	2021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-1919	METHYLPHENIDATE HYDROCHLORIDE TABLET, CHEWABLE [BRYANT RANCH PREPACK]	103	Legacy NDC, 1 package rows	20240110_32887854-16e0-4218-9909-6b2b684c9a9c.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	7293dffd-eb01-43d4-b9c4-04f79bec180c	2024-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210354 application number: ANDA210354
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	XLCare Pharmaceuticals, Inc.	91833146-fa95-471a-8b8d-6d36a2db5c9a	2023-09-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210354 application number: ANDA210354
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Camber Pharmaceuticals Inc.	bb73cd3e-aa7c-4f7e-826d-75e71fb6d1e0	2023-09-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210354 application number: ANDA210354

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1091152	methylphenidate HCl 10 MG Chewable Tablet	PSN	32887854-16e0-4218-9909-6b2b684c9a9c	103
1091152	methylphenidate hydrochloride 10 MG Chewable Tablet	SCD	32887854-16e0-4218-9909-6b2b684c9a9c	103

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-1919-1	63629191901	100 TABLET, CHEWABLE in 1 BOTTLE (63629-1919-1)	2021-01-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methylphenidate Hydrochloride Chewable Tablets CII 2.5 mg, 5 mg and 10 mg Rx only	Bryant Ranch Prepack	2024-01-09	HUMAN PRESCRIPTION DRUG LABEL	103