Methylphenidate Hydrochloride

Product NDC: 57664-710
Requested package NDC: 57664-710-88
11-digit product format: 576640710
Labeler code: 57664
Product ID: 57664-710_5943acc6-3fff-91f4-e063-6294a90a98df
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methylphenidate Hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA217229
Marketing category: ANDA
Marketing start: 2024-12-20
Substance: METHYLPHENIDATE HYDROCHLORIDE
Active strength: 72 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

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A217229-001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	72MG	TABLET, EXTENDED RELEASE / ORAL	AB		2023-08-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217229-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A217229-001	METHYLPHENIDATE HYDROCHLORIDE	72MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217229-001	METHYLPHENIDATE HYDROCHLORIDE	72MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217229-001	METHYLPHENIDATE HYDROCHLORIDE	72MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217229-001	METHYLPHENIDATE HYDROCHLORIDE	72MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217229-001	METHYLPHENIDATE HYDROCHLORIDE	72MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217229-001	METHYLPHENIDATE HYDROCHLORIDE	72MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217229-001	METHYLPHENIDATE HYDROCHLORIDE	72MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217229-001	METHYLPHENIDATE HYDROCHLORIDE	72MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217229-001	METHYLPHENIDATE HYDROCHLORIDE	72MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217229-001	METHYLPHENIDATE HYDROCHLORIDE	72MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217229-001	METHYLPHENIDATE HYDROCHLORIDE	72MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217229-001	METHYLPHENIDATE HYDROCHLORIDE	72MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217229-001	METHYLPHENIDATE HYDROCHLORIDE	72MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217229-001	METHYLPHENIDATE HYDROCHLORIDE	72MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217229-001	METHYLPHENIDATE HYDROCHLORIDE	72MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217229-001	METHYLPHENIDATE HYDROCHLORIDE	72MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217229-001	METHYLPHENIDATE HYDROCHLORIDE	72MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217229-001	METHYLPHENIDATE HYDROCHLORIDE	72MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217229-001	METHYLPHENIDATE HYDROCHLORIDE	72MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217229-001	METHYLPHENIDATE HYDROCHLORIDE	72MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217229-001	METHYLPHENIDATE HYDROCHLORIDE	72MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217229-001	METHYLPHENIDATE HYDROCHLORIDE	72MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A217229-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217229-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217229-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217229-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217229-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217229-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217229-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217229-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217229-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217229-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217229-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217229-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217229-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217229-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217229-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217229-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217229-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217229-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217229-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217229-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217229-001	AB	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217229-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHYLPHENIDATE HYDROCHLORIDE	72 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4B3SC438HI	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1995461	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
18024571-4505-6d51-e063-6294a90a1972	Available on FDA.report

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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
435f0341-cf24-41d5-8fbf-c909821e5596	Product name	1	20230313
c9b6eabb-08d7-bb2d-e81a-06be3590b436	Product name	2	20221216
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
67aa32c6-44f4-50de-64dd-643e8caf420d	Product name	6	20210622
50b24f34-96fa-4f1e-b262-b0baf4a4a440	Product name	4	20210513
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
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
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
7607489b-cd15-3103-f3b1-d4283574d250	Product name	2	20190614
407f0cce-da29-4050-a512-2cabe9e5692d	Product name	9	20190611
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
f7f4bf1e-7c67-46c6-8c42-9beb1a06b38e	Product name	2	20190415
190572d9-6c7b-4b40-8172-c1b5f802c20f	Product name	1	20180724
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
2948856e-f76e-d380-d9ed-b317efafbc98	Product name	5	20180423
c0aa09de-7aa1-4a98-8f70-62ec3c97c695	Product name	1	20170803
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
3317aade-2d6e-f159-9fe6-e8385a825178	Product name	3	20160829
0fe52203-83a7-4fed-a91f-8e47a22cf1d3	Product name	1	20160111
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57664-710-83	Methylphenidate Hydrochloride	30 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	30		2
57664-710-88	Methylphenidate Hydrochloride	100 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	100		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57664-710-83	EA - Each	57664-710	65c892aa-3853-418a-9ab8-67ee651e26db	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57664-710	METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]	1	Current NDC, 2 package rows	20241222_18024571-4505-6d51-e063-6294a90a1972.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Northstar Rx LLC	768bf181-d0d8-49e5-9c87-cacbb069e0b2	2026-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217229 application number: ANDA217229
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	18024571-4505-6d51-e063-6294a90a1972	2026-08-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217229 application number: ANDA217229 ndc (package): 57664-710-88 ndc (product): 57664-710 ndc11 (package): 57664071088

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
1995461	methylphenidate HCl 72 MG 24HR Extended Release Oral Tablet	PSN	18024571-4505-6d51-e063-6294a90a1972	2
1995461	24 HR methylphenidate hydrochloride 72 MG Extended Release Oral Tablet	SCD	18024571-4505-6d51-e063-6294a90a1972	2
1995461	methylphenidate hydrochloride 72 MG 24 HR Extended Release Oral Tablet	SY	18024571-4505-6d51-e063-6294a90a1972	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
57664-710-88	57664071088	100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (57664-710-88)	2024-12-20	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methylphenidate Hydrochloride	Sun Pharmaceutical Industries, Inc. \| Ohm Laboratories Inc.	2026-08-17	HUMAN PRESCRIPTION DRUG LABEL	3