Application 040300

Type: ANDA
Sponsor: SPECGX LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
003	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	TABLET;ORAL	20MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A040300-001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	1998-11-27
A040300-002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1998-11-27
A040300-003	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1998-11-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A040300-001	AB
A040300-002	AB
A040300-003	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 4 · 126 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
2026-08-18 06:07:40	2026-07	A040300-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	1998-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040300-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1998-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040300-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1998-11-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040300-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	1998-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040300-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1998-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040300-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1998-11-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040300-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	1998-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040300-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1998-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040300-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1998-11-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040300-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	1998-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040300-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1998-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040300-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1998-11-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040300-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	1998-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040300-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1998-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040300-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1998-11-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040300-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	1998-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040300-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1998-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040300-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1998-11-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040300-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	1998-11-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040300-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1998-11-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040300-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1998-11-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040300-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	1998-11-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040300-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1998-11-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040300-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1998-11-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040300-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	1998-11-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040300-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1998-11-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040300-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1998-11-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040300-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	1998-11-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040300-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1998-11-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040300-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1998-11-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040300-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	1998-11-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040300-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1998-11-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040300-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1998-11-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040300-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	1998-11-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040300-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1998-11-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040300-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1998-11-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040300-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	1998-11-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040300-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1998-11-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040300-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1998-11-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040300-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	1998-11-27	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040300-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040300-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040300-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040300-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040300-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040300-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040300-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040300-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040300-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040300-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040300-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040300-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040300-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040300-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040300-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040300-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040300-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040300-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040300-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040300-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040300-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040300-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040300-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040300-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040300-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040300-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040300-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040300-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040300-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040300-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040300-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040300-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040300-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040300-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040300-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040300-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040300-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040300-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040300-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040300-001	AB	1	`1e350fbaab3a…`

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	American Health Packaging	eb9b7377-d918-43fb-8e82-d14c85ed64a8	2025-10-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040300 application number: ANDA040300 ndc (product): 68084-805 ndc (product): 68084-823
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	SpecGx LLC	981a2ad8-33f7-4678-9162-9df9685bd4a6	2023-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040300 application number: ANDA040300 ndc (product): 0406-1146 ndc (product): 0406-1142 ndc (product): 0406-1144

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0406-1142	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	SpecGx LLC	ANDA	Current
0406-1142	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	SpecGx LLC	ANDA	Current
0406-1142	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	SpecGx LLC	ANDA	Current
0406-1142	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	SpecGx LLC	ANDA	Current
0406-1142	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	SpecGx LLC	ANDA	Current
0406-1142	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	SpecGx LLC	ANDA	Current
0406-1144	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	SpecGx LLC	ANDA	Current
0406-1144	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	SpecGx LLC	ANDA	Current
0406-1144	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	SpecGx LLC	ANDA	Current
0406-1144	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	SpecGx LLC	ANDA	Current
0406-1144	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	SpecGx LLC	ANDA	Current
0406-1144	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	SpecGx LLC	ANDA	Current
0406-1146	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	SpecGx LLC	ANDA	Current
0406-1146	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	SpecGx LLC	ANDA	Current
0406-1146	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	SpecGx LLC	ANDA	Current
0406-1146	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	SpecGx LLC	ANDA	Current
0406-1146	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	SpecGx LLC	ANDA	Current
0406-1146	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	SpecGx LLC	ANDA	Current
63629-3279	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	bryant ranch prepack	ANDA	Current
68084-805	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	American Health Packaging	ANDA	Current
68084-805	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	American Health Packaging	ANDA	Current
68084-805	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	American Health Packaging	ANDA	Current
68084-805	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	American Health Packaging	ANDA	Current
68084-805	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	American Health Packaging	ANDA	Current
68084-823	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	American Health Packaging	ANDA	Current
68084-823	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	American Health Packaging	ANDA	Current
68084-823	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	American Health Packaging	ANDA	Current
68084-823	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	American Health Packaging	ANDA	Current
68084-823	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	American Health Packaging	ANDA	Current
71335-0892	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0892	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0892	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
17765	ORIG	2004-06-09
22121	ORIG	2003-07-31
7613	ORIG	1998-11-27