FDA.reportPublic FDA data

Methylphenidate Hydrochloride

Product NDC
0406-0154
11-digit product format
004060154
Labeler code
0406
Product ID
0406-0154_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
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
54 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

Additional Listing Data#

Finished product
Yes
Brand name base
Methylphenidate Hydrochloride
Brand name suffix
Extended-Release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE54 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4B3SC438HI
Rxcui2001565, 2001566, 2001568

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
143536be-f21a-464c-bc5a-163f5c171815Product name220250626
fd4d0878-dcea-3832-288e-e3bbbbe580ffProduct name920240516
435f0341-cf24-41d5-8fbf-c909821e5596Product name120230313
c9b6eabb-08d7-bb2d-e81a-06be3590b436Product name220221216
67aa32c6-44f4-50de-64dd-643e8caf420dProduct name620210622
50b24f34-96fa-4f1e-b262-b0baf4a4a440Product name420210513
cf83c421-eebe-4de2-b1a2-fd96e3dbfcf8Product name120200128
166d1d2d-dd55-4fdf-82e2-b83a3c5347c1Product name120190828
343a61d5-785d-cc27-a43a-0779da054d88Product name320190828
7607489b-cd15-3103-f3b1-d4283574d250Product name220190614
407f0cce-da29-4050-a512-2cabe9e5692dProduct name920190611
f7f4bf1e-7c67-46c6-8c42-9beb1a06b38eProduct name220190415
190572d9-6c7b-4b40-8172-c1b5f802c20fProduct name120180724
2948856e-f76e-d380-d9ed-b317efafbc98Product name520180423
c0aa09de-7aa1-4a98-8f70-62ec3c97c695Product name120170803
3317aade-2d6e-f159-9fe6-e8385a825178Product name320160829
0fe52203-83a7-4fed-a91f-8e47a22cf1d3Product name120160111

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0406-0154-01Methylphenidate HydrochlorideExtended-Release100 in 1 BOTTLETABLET, EXTENDED RELEASE10034

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0406-0154-01EA - Each0406-0154dd82257d-79e4-4f35-bd86-7e5c08e2746412013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHYLPHENIDATE HYDROCHLORIDEACTIVE INGREDIENT4B3SC438HIMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]18
METHYLPHENIDATEACTIVE MOIETY207ZZ9QZ49METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]18
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]18
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]18
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]18
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]18
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]18
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]18
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]18
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]18
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]18
OLEIC ACIDINACTIVE INGREDIENT2UMI9U37CPMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]18
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]18
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]18
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]18
SHELLACINACTIVE INGREDIENT46N107B71OMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]18
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]18
TALCINACTIVE INGREDIENT7SEV7J4R1UMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]18
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]18
TRIACETININACTIVE INGREDIENTXHX3C3X673METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0406-0154METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [SPECGX LLC]34Current NDC, Legacy NDC, 1 package rows20241103_b1b0f2ff-d9df-42ab-b471-226ecf97e075.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2001565methylphenidate HCl 27 MG 24HR Extended Release Oral Tablet, BX RatingPSNb1b0f2ff-d9df-42ab-b471-226ecf97e07534
2001566methylphenidate HCl 36 MG 24HR Extended Release Oral Tablet, BX RatingPSNb1b0f2ff-d9df-42ab-b471-226ecf97e07534
2001568methylphenidate HCl 54 MG 24HR Extended Release Oral Tablet, BX RatingPSNb1b0f2ff-d9df-42ab-b471-226ecf97e07534
2001565BX Rating 24 HR methylphenidate hydrochloride 27 MG Extended Release Oral TabletSCDb1b0f2ff-d9df-42ab-b471-226ecf97e07534
2001566BX Rating 24 HR methylphenidate hydrochloride 36 MG Extended Release Oral TabletSCDb1b0f2ff-d9df-42ab-b471-226ecf97e07534
2001568BX Rating 24 HR methylphenidate hydrochloride 54 MG Extended Release Oral TabletSCDb1b0f2ff-d9df-42ab-b471-226ecf97e07534
2001565methylphenidate HCl 27 MG 24HR Extended Release Oral Tablet, BX RatingSYb1b0f2ff-d9df-42ab-b471-226ecf97e07534
2001566methylphenidate HCl 36 MG 24HR Extended Release Oral Tablet, BX RatingSYb1b0f2ff-d9df-42ab-b471-226ecf97e07534
2001568methylphenidate HCl 54 MG 24HR Extended Release Oral Tablet, BX RatingSYb1b0f2ff-d9df-42ab-b471-226ecf97e07534

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0406-0154-0100406015401100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0406-0154-01) 2012-12-280000-00-00NoNoCurrent