Methylphenidate Hydrochloride

Product NDC: 40032-574
11-digit product format: 400320574
Labeler code: 40032
Product ID: 40032-574_07e58ef7-4278-4994-a6f3-ac37d27c3655
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methylphenidate Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Novel Laboratories, Inc.
Application: ANDA207884
Marketing category: ANDA
Marketing start: 2015-11-13
Marketing end: 0000-00-00
Substance: METHYLPHENIDATE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	40032-574		I	Inactivated by FDA	2026-10-05
excluded package	package	40032-574	40032-574-01	I	Inactivated by FDA	2026-10-05
excluded package	package	40032-574	40032-574-03	I	Inactivated by FDA	2026-10-05
excluded package	package	40032-574	40032-574-05	I	Inactivated by FDA	2026-10-05

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 2 · 88 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	40032-574-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	40032-574-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	40032-574-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	40032-574-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	40032-574-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	40032-574-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	40032-574-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	40032-574-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	40032-574-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	40032-574-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	40032-574-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	40032-574-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	40032-574-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	40032-574-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	40032-574-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	40032-574-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	40032-574-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	40032-574-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	40032-574-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	40032-574-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	40032-574-03	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	40032-574-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	40032-574-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	40032-574-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	40032-574-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	40032-574-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	40032-574-03	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	40032-574-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	40032-574-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	40032-574-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	40032-574-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	40032-574-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	40032-574-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	40032-574-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	40032-574-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	40032-574-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	40032-574-05	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	40032-574-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	40032-574-03	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	40032-574-05	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	40032-574-01	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	40032-574-03	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	40032-574-05	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	40032-574-01	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	40032-574-03	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A207884-001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-13
A207884-002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-13
A207884-003	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-11-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207884-001	AB
A207884-002	AB
A207884-003	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 · 129 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
2026-09-14 22:38:34	2026-08	A207884-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207884-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207884-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-11-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207884-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207884-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207884-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-11-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207884-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207884-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207884-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-11-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207884-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207884-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207884-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-11-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207884-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207884-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207884-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-11-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207884-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207884-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207884-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-11-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207884-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207884-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207884-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-11-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207884-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207884-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207884-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-11-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207884-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207884-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207884-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-11-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207884-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207884-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207884-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-11-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207884-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207884-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207884-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-11-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207884-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207884-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207884-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-11-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207884-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207884-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207884-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-11-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207884-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-13	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A207884-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207884-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207884-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207884-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207884-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207884-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207884-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207884-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207884-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207884-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207884-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207884-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207884-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207884-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207884-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207884-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207884-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207884-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207884-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207884-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207884-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207884-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207884-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207884-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207884-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207884-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207884-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207884-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207884-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207884-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207884-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207884-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207884-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207884-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207884-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207884-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207884-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207884-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207884-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207884-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
40032-574-01	2020-01-31	C162847	48780-1	9d75b9d0-5485-f424-e053-dadaa90a57ce	Methylphenidate Hydrochloride Tablets, USP CII Rx only Prescribing Information
40032-574-03	2020-01-31	C162847	48780-1	9d75b9d0-5485-f424-e053-dadaa90a57ce	Methylphenidate Hydrochloride Tablets, USP CII Rx only Prescribing Information
40032-574-05	2020-01-31	C162847	48780-1	9d75b9d0-5485-f424-e053-dadaa90a57ce	Methylphenidate Hydrochloride Tablets, USP CII Rx only Prescribing Information

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
40032-574-01	Methylphenidate Hydrochloride	100 in 1 BOTTLE	TABLET	100	4
40032-574-03	Methylphenidate Hydrochloride	30 in 1 BOTTLE	TABLET	30	4
40032-574-05	Methylphenidate Hydrochloride	500 in 1 BOTTLE	TABLET	500	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
40032-574	METHYLPHENIDATE HYDROCHLORIDE TABLET [NOVEL LABORATORIES, INC.]	4	Legacy NDC, 3 package rows	20160106_e5e705f5-e4f2-46c0-a157-1b4f7413807e.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	Lupin Pharmaceuticals,Inc.	ec8a8896-077d-4dee-9e10-97172512c5ed	2024-03-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207884 application number: ANDA207884

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
1091150	methylphenidate HCl 10 MG Oral Tablet	PSN	e5e705f5-e4f2-46c0-a157-1b4f7413807e	4
1091392	methylphenidate HCl 20 MG Oral Tablet	PSN	e5e705f5-e4f2-46c0-a157-1b4f7413807e	4
1091497	methylphenidate HCl 5 MG Oral Tablet	PSN	e5e705f5-e4f2-46c0-a157-1b4f7413807e	4
1091150	methylphenidate hydrochloride 10 MG Oral Tablet	SCD	e5e705f5-e4f2-46c0-a157-1b4f7413807e	4
1091392	methylphenidate hydrochloride 20 MG Oral Tablet	SCD	e5e705f5-e4f2-46c0-a157-1b4f7413807e	4
1091497	methylphenidate hydrochloride 5 MG Oral Tablet	SCD	e5e705f5-e4f2-46c0-a157-1b4f7413807e	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
40032-574-01	40032057401	100 in 1 BOTTLE	Historical
40032-574-03	40032057403	30 in 1 BOTTLE	Historical
40032-574-05	40032057405	500 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methylphenidate Hydrochloride Tablets, USP CII Rx only Prescribing Information	Novel Laboratories, Inc.	2016-01-05	HUMAN PRESCRIPTION DRUG LABEL	4