METHYLPHENIDATE HYDROCHLORIDE

Product NDC: 50268-529
11-digit product format: 502680529
Labeler code: 50268
Product ID: 50268-529_47e73f94-511d-3879-e063-6394a90ab6af
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: METHYLPHENIDATE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: AvPAK
Application: ANDA207416
Marketing category: ANDA
Marketing start: 2020-02-13
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: 2027-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50268-529		D	Discontinued by firm		2026-09-09
excluded package	package	50268-529	50268-529-15	D	Discontinued by firm		2026-09-09

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
A207416-001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-22
A207416-002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-22
A207416-003	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-09-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207416-001	AB
A207416-002	AB
A207416-003	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	A207416-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207416-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207416-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-09-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207416-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207416-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207416-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-09-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207416-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207416-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207416-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-09-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207416-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207416-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207416-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-09-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207416-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207416-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207416-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-09-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207416-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207416-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207416-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-09-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207416-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207416-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207416-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-09-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207416-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207416-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207416-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-09-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207416-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207416-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207416-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-09-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207416-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207416-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207416-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-09-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207416-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207416-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207416-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-09-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207416-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207416-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207416-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-09-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207416-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207416-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207416-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-09-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207416-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-22	`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	A207416-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207416-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207416-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207416-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207416-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207416-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207416-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207416-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207416-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207416-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207416-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207416-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207416-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207416-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207416-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207416-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207416-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207416-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207416-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207416-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207416-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207416-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207416-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207416-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207416-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207416-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207416-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207416-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207416-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207416-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207416-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207416-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207416-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207416-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207416-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207416-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207416-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207416-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207416-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207416-001	AB	1	`1e350fbaab3a…`

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
50268-529-11	METHYLPHENIDATE HYDROCHLORIDE	1 in 1 BLISTER PACK	TABLET	1		5
50268-529-15	METHYLPHENIDATE HYDROCHLORIDE	50 in 1 BOX	TABLET	50		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50268-529-11	EA - Each	50268-529	6e5445c0-e03e-4afd-a9e6-d86658b8197c	1	2020-03-10
50268-529-15	EA - Each	50268-529	2a586556-0f1d-4df7-963e-4bd7d62bb2b3	1	2020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50268-529	METHYLPHENIDATE HYDROCHLORIDE TABLET [AVPAK]	4	Current NDC, Legacy NDC, 2 package rows	20240110_9e7967c8-d323-160d-e053-2995a90a323e.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Camber Pharmaceutical Inc	778190da-1528-4def-94bf-ee23ee5268a5	2025-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207416 application number: ANDA207416
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	ec3d9304-13bc-4f0b-bf14-1a1ea824bd91	2024-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207416 application number: ANDA207416
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	XLCare Pharmaceuticals Inc	94dc74d4-b4ef-45bc-b502-54ec692e9bd5	2021-08-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207416 application number: ANDA207416

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	9e7967c8-d323-160d-e053-2995a90a323e	5
1091392	methylphenidate HCl 20 MG Oral Tablet	PSN	9e7967c8-d323-160d-e053-2995a90a323e	5
1091150	methylphenidate hydrochloride 10 MG Oral Tablet	SCD	9e7967c8-d323-160d-e053-2995a90a323e	5
1091392	methylphenidate hydrochloride 20 MG Oral Tablet	SCD	9e7967c8-d323-160d-e053-2995a90a323e	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50268-529-11	50268052911	1 in 1 BLISTER PACK						Historical
50268-529-15	50268052915	50 BLISTER PACK in 1 BOX (50268-529-15) / 1 TABLET in 1 BLISTER PACK (50268-529-11)	50 blister pack	2020-02-13	0000-00-00	No	No	Current