Methylphenidate Hydrochloride

Product NDC: 0406-0136
11-digit product format: 004060136
Labeler code: 0406
Product ID: 0406-0136_7a3a8731-e545-455e-83c3-888f4923e901
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methylphenidate Hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: SpecGx LLC
Application: ANDA202608
Marketing category: ANDA
Marketing start: 2012-12-28
Marketing end: 2028-01-31
Substance: METHYLPHENIDATE HYDROCHLORIDE
Active strength: 36 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 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
A202608-001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	2012-12-28
A202608-002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	2012-12-28
A202608-003	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	2012-12-28

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	A202608-001	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL		2012-12-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202608-002	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL		2012-12-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202608-003	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL		2012-12-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202608-001	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202608-002	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202608-003	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202608-001	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202608-002	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202608-003	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202608-001	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202608-002	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202608-003	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202608-001	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202608-002	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202608-003	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202608-001	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202608-002	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202608-003	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202608-001	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202608-002	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202608-003	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202608-001	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202608-002	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202608-003	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202608-001	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202608-002	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202608-003	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202608-001	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202608-002	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202608-003	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202608-001	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202608-002	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202608-003	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202608-001	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202608-002	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202608-003	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202608-001	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202608-002	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202608-003	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202608-001	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 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	A202608-001	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202608-002	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202608-003	BX	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202608-001	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202608-002	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202608-003	BX	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202608-001	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202608-002	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202608-003	BX	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202608-001	BX	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202608-002	BX	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202608-003	BX	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202608-001	BX	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202608-002	BX	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202608-003	BX	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202608-001	BX	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202608-002	BX	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202608-003	BX	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202608-001	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202608-002	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202608-003	BX	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202608-001	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202608-002	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202608-003	BX	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202608-001	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202608-002	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202608-003	BX	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202608-001	BX	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202608-002	BX	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202608-003	BX	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202608-001	BX	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202608-002	BX	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202608-003	BX	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202608-001	BX	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202608-002	BX	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202608-003	BX	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202608-001	BX	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202608-002	BX	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202608-003	BX	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202608-001	BX	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Methylphenidate Hydrochloride
Brand name suffix: Extended-Release

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHYLPHENIDATE HYDROCHLORIDE	36 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
2001565	Internal RxNorm lookup
2001566	Internal RxNorm lookup
2001568	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
b1b0f2ff-d9df-42ab-b471-226ecf97e075	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
0406-0136-01	Methylphenidate HydrochlorideExtended-Release	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100		34

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0406-0136-01	EA - Each	0406-0136	51b951fd-3e49-497e-bd17-f4c61aa358a8	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METHYLPHENIDATE HYDROCHLORIDE	ACTIVE INGREDIENT	4B3SC438HI	METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]	18
METHYLPHENIDATE	ACTIVE MOIETY	207ZZ9QZ49	METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]	18
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]	18
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]	18
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]	18
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]	18
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]	18
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]	18
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]	18
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]	18
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]	18
OLEIC ACID	INACTIVE INGREDIENT	2UMI9U37CP	METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]	18
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]	18
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]	18
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]	18
SHELLAC	INACTIVE INGREDIENT	46N107B71O	METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]	18
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]	18
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]	18
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]	18
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]	18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0406-0136	METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [SPECGX LLC]	34	Current NDC, Legacy NDC, 1 package rows	20241103_b1b0f2ff-d9df-42ab-b471-226ecf97e075.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 Extended-Release	METHYLPHENIDATE HYDROCHLORIDE	SpecGx LLC	b1b0f2ff-d9df-42ab-b471-226ecf97e075	2024-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202608 application number: ANDA202608 ndc (product): 0406-0136

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
2001565	methylphenidate HCl 27 MG 24HR Extended Release Oral Tablet, BX Rating	PSN	b1b0f2ff-d9df-42ab-b471-226ecf97e075	34
2001566	methylphenidate HCl 36 MG 24HR Extended Release Oral Tablet, BX Rating	PSN	b1b0f2ff-d9df-42ab-b471-226ecf97e075	34
2001568	methylphenidate HCl 54 MG 24HR Extended Release Oral Tablet, BX Rating	PSN	b1b0f2ff-d9df-42ab-b471-226ecf97e075	34
2001565	BX Rating 24 HR methylphenidate hydrochloride 27 MG Extended Release Oral Tablet	SCD	b1b0f2ff-d9df-42ab-b471-226ecf97e075	34
2001566	BX Rating 24 HR methylphenidate hydrochloride 36 MG Extended Release Oral Tablet	SCD	b1b0f2ff-d9df-42ab-b471-226ecf97e075	34
2001568	BX Rating 24 HR methylphenidate hydrochloride 54 MG Extended Release Oral Tablet	SCD	b1b0f2ff-d9df-42ab-b471-226ecf97e075	34
2001565	methylphenidate HCl 27 MG 24HR Extended Release Oral Tablet, BX Rating	SY	b1b0f2ff-d9df-42ab-b471-226ecf97e075	34
2001566	methylphenidate HCl 36 MG 24HR Extended Release Oral Tablet, BX Rating	SY	b1b0f2ff-d9df-42ab-b471-226ecf97e075	34
2001568	methylphenidate HCl 54 MG 24HR Extended Release Oral Tablet, BX Rating	SY	b1b0f2ff-d9df-42ab-b471-226ecf97e075	34

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0406-0136-01	00406013601	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0406-0136-01)	2012-12-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methylphenidate Hydrochloride Extended-Release	SpecGx LLC	2024-09-01	HUMAN PRESCRIPTION DRUG LABEL	35