FDA.reportPublic FDA data

Methylphenidate Hydrochloride

Product NDC
0406-1850
11-digit product format
004061850
Labeler code
0406
Product ID
0406-1850_8ba92af8-0db9-4347-95c3-bd06680fc85f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methylphenidate hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
SpecGx LLC
Application
ANDA203583
Marketing category
ANDA
Marketing start
2015-09-29
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
50 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 HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4B3SC438HI
Rxcui1806181, 1806187, 1806189, 1806191, 1806193, 1806197

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
0406-1850-01Methylphenidate HydrochlorideExtended-Release100 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE10028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0406-1850-01EA - Each0406-18504f817f7d-6b93-490a-93b3-96c8392cac0e12017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHYLPHENIDATE HYDROCHLORIDEACTIVE INGREDIENT4B3SC438HIMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
METHYLPHENIDATEACTIVE MOIETY207ZZ9QZ49METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
GELATININACTIVE INGREDIENT2G86QN327LMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
OLEIC ACIDINACTIVE INGREDIENT2UMI9U37CPMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
POVIDONESINACTIVE INGREDIENTFZ989GH94EMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
SHELLACINACTIVE INGREDIENT46N107B71OMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
SUCROSEINACTIVE INGREDIENTC151H8M554METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0406-1850METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [SPECGX LLC]26Current NDC, Legacy NDC, 1 package rows20241222_9e11e093-4ff3-4bed-8fe9-3ee460b47303.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1806181methylphenidate HCl 10 MG 30/70 Release 24HR Extended Release Oral CapsulePSN9e11e093-4ff3-4bed-8fe9-3ee460b4730328
1806187methylphenidate HCl 20 MG 30/70 Release 24HR Extended Release Oral CapsulePSN9e11e093-4ff3-4bed-8fe9-3ee460b4730328
1806189methylphenidate HCl 30 MG 30/70 Release 24HR Extended Release Oral CapsulePSN9e11e093-4ff3-4bed-8fe9-3ee460b4730328
1806191methylphenidate HCl 40 MG 30/70 Release 24HR Extended Release Oral CapsulePSN9e11e093-4ff3-4bed-8fe9-3ee460b4730328
1806193methylphenidate HCl 50 MG 30/70 Release 24HR Extended Release Oral CapsulePSN9e11e093-4ff3-4bed-8fe9-3ee460b4730328
1806197methylphenidate HCl 60 MG 30/70 Release 24HR Extended Release Oral CapsulePSN9e11e093-4ff3-4bed-8fe9-3ee460b4730328
180618130/70 Release 24 HR methylphenidate hydrochloride 10 MG Extended Release Oral CapsuleSCD9e11e093-4ff3-4bed-8fe9-3ee460b4730328
180618730/70 Release 24 HR methylphenidate hydrochloride 20 MG Extended Release Oral CapsuleSCD9e11e093-4ff3-4bed-8fe9-3ee460b4730328
180618930/70 Release 24 HR methylphenidate hydrochloride 30 MG Extended Release Oral CapsuleSCD9e11e093-4ff3-4bed-8fe9-3ee460b4730328
180619130/70 Release 24 HR methylphenidate hydrochloride 40 MG Extended Release Oral CapsuleSCD9e11e093-4ff3-4bed-8fe9-3ee460b4730328
180619330/70 Release 24 HR methylphenidate hydrochloride 50 MG Extended Release Oral CapsuleSCD9e11e093-4ff3-4bed-8fe9-3ee460b4730328
180619730/70 Release 24 HR methylphenidate hydrochloride 60 MG Extended Release Oral CapsuleSCD9e11e093-4ff3-4bed-8fe9-3ee460b4730328
1806181methylphenidate HCl 10 MG 30/70 Release 24HR Extended Release Oral CapsuleSY9e11e093-4ff3-4bed-8fe9-3ee460b4730328
1806187methylphenidate HCl 20 MG 30/70 Release 24HR Extended Release Oral CapsuleSY9e11e093-4ff3-4bed-8fe9-3ee460b4730328
1806189methylphenidate HCl 30 MG 30/70 Release 24HR Extended Release Oral CapsuleSY9e11e093-4ff3-4bed-8fe9-3ee460b4730328
1806191methylphenidate HCl 40 MG 30/70 Release 24HR Extended Release Oral CapsuleSY9e11e093-4ff3-4bed-8fe9-3ee460b4730328
1806193methylphenidate HCl 50 MG 30/70 Release 24HR Extended Release Oral CapsuleSY9e11e093-4ff3-4bed-8fe9-3ee460b4730328
1806197methylphenidate HCl 60 MG 30/70 Release 24HR Extended Release Oral CapsuleSY9e11e093-4ff3-4bed-8fe9-3ee460b4730328

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0406-1850-0100406185001100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0406-1850-01) 2015-09-290000-00-00NoNoCurrent