Methylphenidate Hydrochloride

Product NDC: 0603-4577
11-digit product format: 006034577
Labeler code: 0603
Product ID: 0603-4577_b7b2667b-3380-44f5-98eb-a1561fb1c80c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methylphenidate hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Par Pharmaceutical
Application: ANDA202892
Marketing category: ANDA
Marketing start: 2014-09-23
Marketing end: 2021-05-31
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: 0000-00-00
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0603-4577		D	Discontinued by firm		2026-08-03
excluded package	package	0603-4577	0603-4577-21	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 14 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product	0603-4577		D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0603-4577	0603-4577-21	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product	0603-4577		D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0603-4577	0603-4577-21	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	0603-4577		D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0603-4577	0603-4577-21	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	0603-4577		D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0603-4577	0603-4577-21	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product	0603-4577		D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0603-4577	0603-4577-21	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product	0603-4577		D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0603-4577	0603-4577-21	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product	0603-4577		D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0603-4577	0603-4577-21	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

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
A202892-001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-23
A202892-002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-09-23
A202892-003	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-09-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202892-001	AB
A202892-002	AB
A202892-003	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 · 123 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	A202892-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202892-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202892-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-09-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202892-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202892-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202892-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-09-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202892-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202892-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202892-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-09-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202892-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202892-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202892-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-09-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202892-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202892-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-09-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202892-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-09-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202892-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202892-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202892-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-09-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202892-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202892-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202892-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-09-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202892-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202892-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202892-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-09-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202892-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202892-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-09-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202892-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-09-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202892-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202892-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-09-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202892-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-09-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202892-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202892-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-09-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202892-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-09-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202892-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202892-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-09-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202892-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-09-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202892-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202892-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-09-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202892-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-09-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202892-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-23	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A202892-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202892-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202892-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202892-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202892-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202892-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202892-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202892-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202892-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202892-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202892-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202892-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202892-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202892-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202892-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202892-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202892-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202892-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202892-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202892-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202892-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202892-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202892-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202892-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202892-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202892-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202892-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202892-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202892-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202892-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202892-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202892-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202892-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202892-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202892-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202892-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202892-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202892-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202892-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202892-001	AB	1	`8072bd15b7f6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0603-4577-21	EA - Each	0603-4577	5675bbce-4059-497b-838a-2cee5f28ac52	1	2015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METHYLPHENIDATE HYDROCHLORIDE	ACTIVE INGREDIENT	4B3SC438HI	METHYLPHENIDATE HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]	7
METHYLPHENIDATE	ACTIVE MOIETY	207ZZ9QZ49	METHYLPHENIDATE HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METHYLPHENIDATE HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]	7
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	METHYLPHENIDATE HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]	7
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	METHYLPHENIDATE HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]	7
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	METHYLPHENIDATE HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METHYLPHENIDATE HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]	7
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METHYLPHENIDATE HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]	7
SUCROSE	INACTIVE INGREDIENT	C151H8M554	METHYLPHENIDATE HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]	7

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0603-4577-21	00603457721	100 TABLET in 1 BOTTLE, PLASTIC (0603-4577-21)	100 tablet	2014-09-23	2021-05-31	No	No	Current