Methylphenidate Hydrochloride

Product NDC: 0406-1473
Requested package NDC: 0406-1473-01
11-digit product format: 004061473
Labeler code: 0406
Product ID: 0406-1473_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: 20 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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	0406-1473	0406-1473-01	D	Discontinued by firm		2026-08-03

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…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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): 0406-1473-01 ndc (product): 0406-1473 ndc11 (package): 00406147301

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	20 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
0406-1473-01	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
0406-1473-01	EA - Each	0406-1473	e1a6df3d-4481-4b3b-86c5-2deb815a9aa5	1	2012-07-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0406-1473	METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SPECGX LLC]	1	Current NDC, Legacy NDC, 1 package rows	20240713_ed004cf0-eb23-43d2-96dc-20c4ad63824f.zip

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
0406-1473-01	00406147301	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0406-1473-01)	2000-05-09	0000-00-00	No	No	Current