METHYLPHENIDATE HYDROCHLORIDE

Product NDC: 16729-478
11-digit product format: 167290478
Labeler code: 16729
Product ID: 16729-478_1b2d1579-1bb4-cc17-e063-6294a90a4fa7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: METHYLPHENIDATE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: Accord Healthcare, Inc.
Application: ANDA213936
Marketing category: ANDA
Marketing start: 2020-12-23
Substance: METHYLPHENIDATE HYDROCHLORIDE
Active strength: 5 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

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
A213936-001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-28
A213936-002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-28
A213936-003	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2020-10-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213936-001	AB
A213936-002	AB
A213936-003	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 3 · 108 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	A213936-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213936-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213936-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2020-10-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213936-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213936-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213936-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2020-10-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213936-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213936-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213936-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2020-10-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213936-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213936-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213936-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2020-10-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213936-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213936-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213936-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2020-10-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213936-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213936-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213936-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2020-10-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213936-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213936-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213936-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2020-10-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213936-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213936-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213936-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2020-10-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213936-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213936-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213936-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2020-10-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213936-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213936-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213936-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2020-10-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213936-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213936-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213936-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2020-10-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213936-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213936-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213936-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2020-10-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213936-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213936-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213936-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2020-10-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213936-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-10-28	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 108 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	A213936-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213936-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213936-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213936-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213936-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213936-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213936-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213936-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213936-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213936-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213936-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213936-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213936-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213936-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213936-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213936-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213936-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213936-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213936-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213936-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213936-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213936-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213936-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213936-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213936-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213936-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213936-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213936-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213936-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213936-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213936-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213936-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213936-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213936-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213936-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213936-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213936-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213936-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213936-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213936-001	AB	1	`8072bd15b7f6…`

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	5 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1091150	Internal RxNorm lookup
1091392	Internal RxNorm lookup
1091497	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
4f3c91e6-4576-4326-bdab-7d8fb7c09bb8	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
16729-478-01	METHYLPHENIDATE HYDROCHLORIDE	100 in 1 BOTTLE	TABLET	100		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16729-478	METHYLPHENIDATE HYDROCHLORIDE TABLET [ACCORD HEALTHCARE, INC.]	7	Current NDC, Legacy NDC, 1 package rows	20240619_4f3c91e6-4576-4326-bdab-7d8fb7c09bb8.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	Accord Healthcare, Inc.	4f3c91e6-4576-4326-bdab-7d8fb7c09bb8	2024-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213936 application number: ANDA213936 ndc (product): 16729-478

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	4f3c91e6-4576-4326-bdab-7d8fb7c09bb8	7
1091392	methylphenidate HCl 20 MG Oral Tablet	PSN	4f3c91e6-4576-4326-bdab-7d8fb7c09bb8	7
1091497	methylphenidate HCl 5 MG Oral Tablet	PSN	4f3c91e6-4576-4326-bdab-7d8fb7c09bb8	7
1091150	methylphenidate hydrochloride 10 MG Oral Tablet	SCD	4f3c91e6-4576-4326-bdab-7d8fb7c09bb8	7
1091392	methylphenidate hydrochloride 20 MG Oral Tablet	SCD	4f3c91e6-4576-4326-bdab-7d8fb7c09bb8	7
1091497	methylphenidate hydrochloride 5 MG Oral Tablet	SCD	4f3c91e6-4576-4326-bdab-7d8fb7c09bb8	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16729-478-01	16729047801	100 TABLET in 1 BOTTLE (16729-478-01)	100 tablet	2020-12-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
METHYLPHENIDATE HYDROCHLORIDE	Accord Healthcare, Inc. \| WES Pharma Inc.	2024-06-18	HUMAN PRESCRIPTION DRUG LABEL	7