Methylphenidate Hydrochloride

Product NDC: 43386-570
Requested package NDC: 43386-570-01
11-digit product format: 433860570
Labeler code: 43386
Product ID: 43386-570_c9e22f02-1ba0-41b6-ad52-181d18094553
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methylphenidate Hydrochloride
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Lupin Pharmaceuticals,Inc.
Application: ANDA204115
Marketing category: ANDA
Marketing start: 2015-04-06
Substance: METHYLPHENIDATE HYDROCHLORIDE
Active strength: 2.5 mg/1
Pharmacologic classes: Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 45.

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
A204115-001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	2015-02-25
A204115-002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	2015-02-25
A204115-003	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	2015-02-25

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 · 135 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-11-14 07:37:17	2026-10	A204115-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	2015-02-25	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	A204115-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	2015-02-25	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	A204115-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	2015-02-25	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	A204115-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	2015-02-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A204115-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	2015-02-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A204115-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	2015-02-25	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A204115-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	2015-02-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204115-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	2015-02-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204115-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	2015-02-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204115-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	2015-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204115-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	2015-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204115-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	2015-02-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204115-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	2015-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204115-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	2015-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204115-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	2015-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204115-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	2015-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204115-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	2015-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204115-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	2015-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204115-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	2015-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204115-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	2015-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204115-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	2015-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204115-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	2015-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204115-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	2015-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204115-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	2015-02-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204115-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	2015-02-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204115-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	2015-02-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204115-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	2015-02-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204115-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	2015-02-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204115-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	2015-02-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204115-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	2015-02-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204115-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	2015-02-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204115-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	2015-02-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204115-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	2015-02-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204115-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	2015-02-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204115-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	2015-02-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204115-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	2015-02-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204115-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	2015-02-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204115-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	2015-02-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204115-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	2015-02-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204115-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	2015-02-25	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A204115-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204115-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204115-003	AB	1	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	A204115-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204115-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204115-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204115-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204115-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204115-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204115-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A204115-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A204115-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204115-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A204115-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A204115-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204115-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A204115-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A204115-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204115-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204115-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204115-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204115-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204115-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204115-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204115-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204115-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204115-003	AB	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

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

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	2.5 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
1091152	Internal RxNorm lookup
1091322	Internal RxNorm lookup
1091389	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
5bfe50ed-171f-4c40-bc0b-20c68e8e2025	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
43386-570-01	Methylphenidate Hydrochloride	100 in 1 BOTTLE	TABLET, CHEWABLE	100		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43386-570-01	EA - Each	43386-570	747b4252-7c5e-4203-9668-341532d4778c	1	2015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METHYLPHENIDATE HYDROCHLORIDE	ACTIVE INGREDIENT	4B3SC438HI	METHYLPHENIDATE HYDROCHLORIDE TABLET, CHEWABLE [GAVIS PHARMACEUTICALS, LLC]	1
METHYLPHENIDATE	ACTIVE MOIETY	207ZZ9QZ49	METHYLPHENIDATE HYDROCHLORIDE TABLET, CHEWABLE [GAVIS PHARMACEUTICALS, LLC]	1
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	METHYLPHENIDATE HYDROCHLORIDE TABLET, CHEWABLE [GAVIS PHARMACEUTICALS, LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METHYLPHENIDATE HYDROCHLORIDE TABLET, CHEWABLE [GAVIS PHARMACEUTICALS, LLC]	1
MALTOSE	INACTIVE INGREDIENT	XJ6S9RV06F	METHYLPHENIDATE HYDROCHLORIDE TABLET, CHEWABLE [GAVIS PHARMACEUTICALS, LLC]	1
PHOSPHORIC ACID	INACTIVE INGREDIENT	E4GA8884NN	METHYLPHENIDATE HYDROCHLORIDE TABLET, CHEWABLE [GAVIS PHARMACEUTICALS, LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	METHYLPHENIDATE HYDROCHLORIDE TABLET, CHEWABLE [GAVIS PHARMACEUTICALS, LLC]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	METHYLPHENIDATE HYDROCHLORIDE TABLET, CHEWABLE [GAVIS PHARMACEUTICALS, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43386-570	METHYLPHENIDATE HYDROCHLORIDE TABLET, CHEWABLE [LUPIN PHARMACEUTICALS,INC.]	7	Current NDC, Legacy NDC, 1 package rows	20231214_5bfe50ed-171f-4c40-bc0b-20c68e8e2025.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.	5bfe50ed-171f-4c40-bc0b-20c68e8e2025	2023-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204115 application number: ANDA204115 ndc (package): 43386-570-01 ndc (product): 43386-570 ndc11 (package): 43386057001

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
1091152	methylphenidate HCl 10 MG Chewable Tablet	PSN	5bfe50ed-171f-4c40-bc0b-20c68e8e2025	7
1091389	methylphenidate HCl 2.5 MG Chewable Tablet	PSN	5bfe50ed-171f-4c40-bc0b-20c68e8e2025	7
1091322	methylphenidate HCl 5 MG Chewable Tablet	PSN	5bfe50ed-171f-4c40-bc0b-20c68e8e2025	7
1091152	methylphenidate hydrochloride 10 MG Chewable Tablet	SCD	5bfe50ed-171f-4c40-bc0b-20c68e8e2025	7
1091389	methylphenidate hydrochloride 2.5 MG Chewable Tablet	SCD	5bfe50ed-171f-4c40-bc0b-20c68e8e2025	7
1091322	methylphenidate hydrochloride 5 MG Chewable Tablet	SCD	5bfe50ed-171f-4c40-bc0b-20c68e8e2025	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43386-570-01	43386057001	100 TABLET, CHEWABLE in 1 BOTTLE (43386-570-01)	2015-04-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methylphenidate HCl Chewable Tablets CII Rx only	Lupin Pharmaceuticals,Inc. \| Novel Laboratories, Inc.	2023-12-11	HUMAN PRESCRIPTION DRUG LABEL	7