METHYLPHENIDATE HYDROCHLORIDE

Product NDC: 70010-042
Requested package NDC: 70010-042-03
11-digit product format: 700100042
Labeler code: 70010
Product ID: 70010-042_4d32fc20-a85a-ae84-e063-6294a90ade10
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: METHYLPHENIDATE HYDROCHLORIDE
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Granules Pharmaceuticals Inc.
Application: ANDA210992
Marketing category: ANDA
Marketing start: 2018-12-17
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: 2027-12-31
Current FDA listing: Yes

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 · 3 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	Archive	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70010-042	70010-042-03	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70010-042	70010-042-03	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70010-042	70010-042-03	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210992-001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-11-21
A210992-002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-11-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A210992-001	AB
A210992-002	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 3 · 82 observed 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	A210992-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210992-002	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210992-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210992-002	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210992-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210992-002	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210992-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210992-002	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210992-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210992-002	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210992-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210992-002	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210992-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210992-002	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210992-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210992-002	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210992-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210992-002	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210992-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210992-002	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210992-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210992-002	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210992-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210992-002	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210992-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210992-002	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210992-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210992-002	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210992-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210992-002	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210992-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210992-002	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210992-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210992-002	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210992-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210992-002	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210992-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210992-002	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210992-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210992-002	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A210992-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210992-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210992-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210992-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210992-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210992-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210992-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210992-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210992-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210992-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210992-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210992-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210992-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210992-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210992-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210992-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210992-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210992-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210992-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210992-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210992-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210992-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210992-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210992-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210992-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210992-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210992-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210992-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210992-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210992-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210992-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210992-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210992-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210992-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210992-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210992-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210992-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210992-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210992-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210992-002	AB	1	`782e0a99824c…`

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	10 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1091145	Internal RxNorm lookup
1091225	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
45d33807-88b2-4b42-9c86-e5b05d7adec1	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
70010-042-01	2025-03-06	Methylphenidate hydrochloride extended-release tablets, USP These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1955
70010-042-01	2025-03-06	Methylphenidate hydrochloride extended-release tablets, USP These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1955
70010-042-01	2025-03-06	Methylphenidate hydrochloride extended-release tablets, USP These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1955
70010-042-01	2025-03-06	Methylphenidate hydrochloride extended-release tablets, USP These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1955
70010-042-03	2025-03-06	Methylphenidate hydrochloride extended-release tablets, USP These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1955
70010-042-03	2025-03-06	Methylphenidate hydrochloride extended-release tablets, USP These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1955
70010-042-03	2025-03-06	Methylphenidate hydrochloride extended-release tablets, USP These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1955
70010-042-03	2025-03-06	Methylphenidate hydrochloride extended-release tablets, USP These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1955
70010-042-01	2025-01-30	Methylphenidate hydrochloride extended-release tablets, USP These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1955
70010-042-01	2025-01-30	Methylphenidate hydrochloride extended-release tablets, USP These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1955
70010-042-01	2025-01-30	Methylphenidate hydrochloride extended-release tablets, USP These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1955
70010-042-01	2025-01-30	Methylphenidate hydrochloride extended-release tablets, USP These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1955
70010-042-03	2025-01-30	Methylphenidate hydrochloride extended-release tablets, USP These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1955
70010-042-03	2025-01-30	Methylphenidate hydrochloride extended-release tablets, USP These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1955
70010-042-03	2025-01-30	Methylphenidate hydrochloride extended-release tablets, USP These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1955
70010-042-03	2025-01-30	Methylphenidate hydrochloride extended-release tablets, USP These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1955

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70010-042-01	METHYLPHENIDATE HYDROCHLORIDE	100 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	100		10
70010-042-03	METHYLPHENIDATE HYDROCHLORIDE	30 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	30		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70010-042-01	EA - Each	70010-042	d0dfa89c-b8e2-4990-a62f-023542b0ed21	1	2019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70010-042	METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [GRANULES PHARMACEUTICALS INC.]	7	Current NDC, Legacy NDC, 2 package rows	20250309_45d33807-88b2-4b42-9c86-e5b05d7adec1.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	Granules Pharmaceuticals Inc.	45d33807-88b2-4b42-9c86-e5b05d7adec1	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210992 application number: ANDA210992 ndc (package): 70010-042-03 ndc (product): 70010-042 ndc11 (package): 70010004203
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Golden State Medical Supply, Inc.	98be5c84-b348-6b8e-e053-2995a90ae4cc	2026-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210992 application number: ANDA210992

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
1091145	methylphenidate HCl 10 MG 8HR Extended Release Oral Tablet	PSN	45d33807-88b2-4b42-9c86-e5b05d7adec1	10
1091225	methylphenidate HCl 20 MG 8HR Extended Release Oral Tablet	PSN	45d33807-88b2-4b42-9c86-e5b05d7adec1	10
1091145	8 HR methylphenidate hydrochloride 10 MG Extended Release Oral Tablet	SCD	45d33807-88b2-4b42-9c86-e5b05d7adec1	10
1091225	8 HR methylphenidate hydrochloride 20 MG Extended Release Oral Tablet	SCD	45d33807-88b2-4b42-9c86-e5b05d7adec1	10
1091145	methylphenidate HCl 10 MG 8 HR Extended Release Oral Tablet	SY	45d33807-88b2-4b42-9c86-e5b05d7adec1	10
1091225	methylphenidate HCl 20 MG 8 HR Extended Release Oral Tablet	SY	45d33807-88b2-4b42-9c86-e5b05d7adec1	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
70010-042-03	70010004203	30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70010-042-03)	2022-10-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
METHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	2026-07-17	HUMAN PRESCRIPTION DRUG LABEL	11