Methylphenidate Hydrochloride

Product NDC: 72603-399
11-digit product format: 726030399
Labeler code: 72603
Product ID: 72603-399_24936e25-28cd-53ce-e063-6294a90ad99d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methylphenidate Hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Northstar Rx LLC
Application: ANDA217229
Marketing category: ANDA
Marketing start: 2025-02-01
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: 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 · 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
2026-02-19 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
2026-02-19 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…`

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	Sun Pharmaceutical Industries, Inc.	18024571-4505-6d51-e063-6294a90a1972	2026-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217229 application number: ANDA217229
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Northstar Rx LLC	768bf181-d0d8-49e5-9c87-cacbb069e0b2	2026-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217229 application number: ANDA217229 ndc (product): 72603-399

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
768bf181-d0d8-49e5-9c87-cacbb069e0b2	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
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
72603-399-01	Methylphenidate Hydrochloride	30 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72603-399-01	EA - Each	72603-399	55a04d04-9390-4ec5-bf0e-48b2f31dafaf	1	2025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72603-399	METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [NORTHSTAR RX LLC]	1	Current NDC, 1 package rows	20250201_768bf181-d0d8-49e5-9c87-cacbb069e0b2.zip

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	Marketing start	Sample	Exclude flag	Status
72603-399-01	72603039901	30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72603-399-01)	2025-02-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methylphenidate Hydrochloride	Northstar Rx LLC \| Ohm Laboratories Inc.	2026-04-02	HUMAN PRESCRIPTION DRUG LABEL	2