Methylphenidate Hydrochloride

Product NDC: 13107-382
11-digit product format: 131070382
Labeler code: 13107
Product ID: 13107-382_f821bfff-5013-4850-8e10-33e5c146df4a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methylphenidate Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Aurolife Pharma, LLC
Application: ANDA209276
Marketing category: ANDA
Marketing start: 2017-04-11
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: 2026-12-31
Current FDA listing: Yes

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 1 · 8 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
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	13107-382-01	`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	13107-382-01	`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	13107-382-01	`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	13107-382-01	`1332a3947898…`	`d4bfe170f9cd…`

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	Approval date
A209276-001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2018-10-25
A209276-002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-10-25
A209276-003	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2018-10-25

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A209276-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2018-10-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209276-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-10-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209276-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2018-10-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209276-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2018-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209276-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209276-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2018-10-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209276-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2018-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209276-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209276-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2018-10-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209276-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2018-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209276-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209276-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2018-10-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209276-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2018-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209276-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209276-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2018-10-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209276-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2018-10-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209276-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-10-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209276-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2018-10-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209276-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2018-10-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209276-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-10-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209276-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2018-10-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209276-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2018-10-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209276-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-10-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209276-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2018-10-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209276-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2018-10-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209276-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-10-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209276-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2018-10-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209276-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2018-10-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209276-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-10-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209276-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2018-10-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209276-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2018-10-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209276-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-10-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209276-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2018-10-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209276-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2018-10-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209276-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-10-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209276-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2018-10-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209276-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2018-10-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209276-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-10-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209276-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2018-10-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209276-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2018-10-25	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: Methylphenidate Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHYLPHENIDATE HYDROCHLORIDE	20 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 SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
35be77db-fbe3-487e-a220-a08a11aaec28	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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-08-07	Methlyphenidate Hydrochloride Tablets, USP CII These highlights do not include all the information needed to use Methlyphenidate Hydrochloride Tablet safely and effectively. See full prescribing information for Methlyphenidate Hydrochloride Tablet. Initial U.S. Approval: 1955
2024-08-07	These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE TABLETS. METHYLPHENIDATE HYDROCHLORIDE tablets for oral use, CII Initial U.S. Approval: 1955
2023-01-30	Methlyphenidate Hydrochloride Tablets, USP CII These highlights do not include all the information needed to use Methlyphenidate Hydrochloride Tablet safely and effectively. See full prescribing information for Methlyphenidate Hydrochloride Tablet. Initial U.S. Approval: 1955
2023-01-30	These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE TABLETS. METHYLPHENIDATE HYDROCHLORIDE tablets for oral use, CII Initial U.S. Approval: 1955

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
13107-382-01	Methylphenidate Hydrochloride	100 in 1 BOTTLE	TABLET	100		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13107-382	METHYLPHENIDATE HYDROCHLORIDE TABLET [AUROLIFE PHARMA, LLC]	3	Current NDC, Legacy NDC, 1 package rows	20240808_35be77db-fbe3-487e-a220-a08a11aaec28.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	Aurolife Pharma, LLC	35be77db-fbe3-487e-a220-a08a11aaec28	2026-08-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209276 application number: ANDA209276 ndc (product): 13107-382

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	35be77db-fbe3-487e-a220-a08a11aaec28	4
1091392	methylphenidate HCl 20 MG Oral Tablet	PSN	35be77db-fbe3-487e-a220-a08a11aaec28	4
1091497	methylphenidate HCl 5 MG Oral Tablet	PSN	35be77db-fbe3-487e-a220-a08a11aaec28	4
1091150	methylphenidate hydrochloride 10 MG Oral Tablet	SCD	35be77db-fbe3-487e-a220-a08a11aaec28	4
1091392	methylphenidate hydrochloride 20 MG Oral Tablet	SCD	35be77db-fbe3-487e-a220-a08a11aaec28	4
1091497	methylphenidate hydrochloride 5 MG Oral Tablet	SCD	35be77db-fbe3-487e-a220-a08a11aaec28	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
13107-382-01	13107038201	100 TABLET in 1 BOTTLE (13107-382-01)	100 tablet	2017-04-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methylphenidate Hydrochloride	Aurolife Pharma, LLC \| JANSSEN PHARMACEUTICALS, INC.	2026-08-13	Human Prescription Drug Label	5