Methylphenidate Hydrochloride

Product NDC: 0406-1445
Requested package NDC: 0406-1445-01
11-digit product format: 004061445
Labeler code: 0406
Product ID: 0406-1445_7bfd27d5-70ed-440b-949a-140aa3304d4a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methylphenidate Hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: SpecGx LLC
Application: ANDA075629
Marketing category: ANDA
Marketing start: 2000-05-09
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: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0406-1445	0406-1445-01	D	Discontinued by firm		2026-08-03

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 · 11 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`

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
A075629-001	METHYLIN ER	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-05-09
A075629-002	METHYLIN ER	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-05-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075629-001	AB
A075629-002	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	A075629-001	METHYLIN ER	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-05-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075629-002	METHYLIN ER	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-05-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075629-001	METHYLIN ER	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-05-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075629-002	METHYLIN ER	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-05-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075629-001	METHYLIN ER	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-05-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075629-002	METHYLIN ER	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-05-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075629-001	METHYLIN ER	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-05-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075629-002	METHYLIN ER	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-05-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075629-001	METHYLIN ER	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-05-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075629-002	METHYLIN ER	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-05-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075629-001	METHYLIN ER	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-05-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075629-002	METHYLIN ER	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-05-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075629-001	METHYLIN ER	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-05-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075629-002	METHYLIN ER	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-05-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075629-001	METHYLIN ER	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-05-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075629-002	METHYLIN ER	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-05-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075629-001	METHYLIN ER	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-05-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075629-002	METHYLIN ER	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-05-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075629-001	METHYLIN ER	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-05-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075629-002	METHYLIN ER	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-05-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075629-001	METHYLIN ER	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-05-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075629-002	METHYLIN ER	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-05-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075629-001	METHYLIN ER	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-05-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075629-002	METHYLIN ER	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-05-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075629-001	METHYLIN ER	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-05-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075629-002	METHYLIN ER	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-05-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075629-001	METHYLIN ER	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-05-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075629-002	METHYLIN ER	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-05-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075629-001	METHYLIN ER	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-05-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075629-002	METHYLIN ER	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-05-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075629-001	METHYLIN ER	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-05-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075629-002	METHYLIN ER	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-05-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075629-001	METHYLIN ER	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-05-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075629-002	METHYLIN ER	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-05-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075629-001	METHYLIN ER	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-05-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075629-002	METHYLIN ER	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-05-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075629-001	METHYLIN ER	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-05-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075629-002	METHYLIN ER	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-05-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075629-001	METHYLIN ER	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-05-09	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075629-002	METHYLIN ER	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-05-09	`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	A075629-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075629-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075629-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075629-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075629-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075629-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075629-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075629-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075629-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075629-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075629-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075629-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075629-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075629-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075629-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075629-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075629-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075629-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075629-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075629-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075629-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075629-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075629-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075629-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075629-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075629-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075629-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075629-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075629-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075629-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075629-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075629-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075629-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075629-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075629-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075629-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075629-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075629-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075629-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075629-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Methylphenidate Hydrochloride
Listing expiration: 2026-12-31

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
ed004cf0-eb23-43d2-96dc-20c4ad63824f	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
0406-1445-01	Methylphenidate Hydrochloride	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0406-1445-01	EA - Each	0406-1445	9ca8c853-b0c0-44c1-99e2-e047b8b5f2da	1	2012-07-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0406-1445	METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SPECGX LLC]	1	Current NDC, Legacy NDC, 1 package rows	20240713_ed004cf0-eb23-43d2-96dc-20c4ad63824f.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
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	SpecGx LLC	ed004cf0-eb23-43d2-96dc-20c4ad63824f	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075629 application number: ANDA075629 ndc (package): 0406-1445-01 ndc (product): 0406-1445 ndc11 (package): 00406144501

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	ed004cf0-eb23-43d2-96dc-20c4ad63824f	3
1091225	methylphenidate HCl 20 MG 8HR Extended Release Oral Tablet	PSN	ed004cf0-eb23-43d2-96dc-20c4ad63824f	3
1091145	8 HR methylphenidate hydrochloride 10 MG Extended Release Oral Tablet	SCD	ed004cf0-eb23-43d2-96dc-20c4ad63824f	3
1091225	8 HR methylphenidate hydrochloride 20 MG Extended Release Oral Tablet	SCD	ed004cf0-eb23-43d2-96dc-20c4ad63824f	3
1091145	methylphenidate HCl 10 MG 8 HR Extended Release Oral Tablet	SY	ed004cf0-eb23-43d2-96dc-20c4ad63824f	3
1091225	methylphenidate HCl 20 MG 8 HR Extended Release Oral Tablet	SY	ed004cf0-eb23-43d2-96dc-20c4ad63824f	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0406-1445-01	00406144501	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0406-1445-01)	2000-05-09	0000-00-00	No	No	Current