Methylphenidate Hydrochloride

Product NDC: 0406-0127
11-digit product format: 004060127
Labeler code: 0406
Product ID: 0406-0127_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: 2027-06-30
Substance: METHYLPHENIDATE HYDROCHLORIDE
Active strength: 27 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	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 3 · 99 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
2024-11-08 22:44 UTC · 2 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 · 2 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 · 2 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…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202608-002	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202608-003	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202608-001	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202608-002	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202608-003	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202608-001	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202608-002	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202608-003	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202608-001	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202608-002	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202608-003	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202608-001	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202608-002	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202608-003	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202608-001	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202608-002	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202608-003	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202608-001	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202608-002	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202608-003	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202608-001	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202608-002	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202608-003	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202608-001	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202608-002	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202608-003	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202608-001	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	BX	2012-12-28	`5aa47cf7b7d7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 96 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-11-08 22:44 UTC · 2 captures of this ZIP	2024-11	A202608-001	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 2 captures of this ZIP	2024-11	A202608-002	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 2 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…`
2024-05-31 18:47 UTC	2024-05	A202608-002	BX	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202608-003	BX	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202608-001	BX	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202608-002	BX	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202608-003	BX	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202608-001	BX	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202608-002	BX	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202608-003	BX	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202608-001	BX	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202608-002	BX	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202608-003	BX	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202608-001	BX	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202608-002	BX	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202608-003	BX	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202608-001	BX	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202608-002	BX	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202608-003	BX	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202608-001	BX	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202608-002	BX	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202608-003	BX	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202608-001	BX	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202608-002	BX	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202608-003	BX	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202608-001	BX	1	`5aa47cf7b7d7…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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): 0406-0127

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	27 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
0406-0127-01	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
0406-0127-01	EA - Each	0406-0127	f3e8a39a-f662-46c4-9550-4e5607b388cf	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
0406-0127	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

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
0406-0127-01	00406012701	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0406-0127-01)	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