FDA.reportPublic FDA data

Methylin

Product NDC
59630-750
11-digit product format
596300750
Labeler code
59630
Product ID
59630-750_64c7c464-4ef5-401a-ab3c-c0443e5e31a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylphenidate Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
SHIONOGI INC.
Application
NDA021419
Marketing category
NDA
Marketing start
2002-12-19
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
5 mg/5mL
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
Methylin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4B3SC438HI
Rxcui1091133, 1091135, 1091341, 1091343

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
59630-750-50Methylin500 mL in 1 BOTTLESOLUTION50032

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59630-750-50ML - Milliliter59630-7503abe798b-0f71-44be-a135-99103370d53412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHYLPHENIDATE HYDROCHLORIDEACTIVE INGREDIENT4B3SC438HIMETHYLIN (METHYLPHENIDATE HYDROCHLORIDE) SOLUTION [SHIONOGI INC.]17
METHYLPHENIDATEACTIVE MOIETY207ZZ9QZ49METHYLIN (METHYLPHENIDATE HYDROCHLORIDE) SOLUTION [SHIONOGI INC.]17
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLMETHYLIN (METHYLPHENIDATE HYDROCHLORIDE) SOLUTION [SHIONOGI INC.]17
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMETHYLIN (METHYLPHENIDATE HYDROCHLORIDE) SOLUTION [SHIONOGI INC.]17
POLYETHYLENE GLYCOL 1450INACTIVE INGREDIENTOJ4Z5Z32L4METHYLIN (METHYLPHENIDATE HYDROCHLORIDE) SOLUTION [SHIONOGI INC.]17
WATERINACTIVE INGREDIENT059QF0KO0RMETHYLIN (METHYLPHENIDATE HYDROCHLORIDE) SOLUTION [SHIONOGI INC.]17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59630-750METHYLIN (METHYLPHENIDATE HYDROCHLORIDE) SOLUTION [SHIONOGI INC.]32Current NDC, Legacy NDC, 1 package rows20240724_9e3c22d9-71d9-46a7-b315-8021c94c4bec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1091135Methylin 10 MG in 5 mL Oral SolutionPSN9e3c22d9-71d9-46a7-b315-8021c94c4bec32
1091343Methylin 5 MG in 5 mL Oral SolutionPSN9e3c22d9-71d9-46a7-b315-8021c94c4bec32
1091133methylphenidate HCl 10 MG in 5 mL Oral SolutionPSN9e3c22d9-71d9-46a7-b315-8021c94c4bec32
1091341methylphenidate HCl 5 MG in 5 mL Oral SolutionPSN9e3c22d9-71d9-46a7-b315-8021c94c4bec32
1091343methylphenidate hydrochloride 1 MG/ML Oral Solution [Methylin]SBD9e3c22d9-71d9-46a7-b315-8021c94c4bec32
1091135methylphenidate hydrochloride 2 MG/ML Oral Solution [Methylin]SBD9e3c22d9-71d9-46a7-b315-8021c94c4bec32
1091341methylphenidate hydrochloride 1 MG/ML Oral SolutionSCD9e3c22d9-71d9-46a7-b315-8021c94c4bec32
1091133methylphenidate hydrochloride 2 MG/ML Oral SolutionSCD9e3c22d9-71d9-46a7-b315-8021c94c4bec32
1091343Methylin 1 MG/ML Oral SolutionSY9e3c22d9-71d9-46a7-b315-8021c94c4bec32
1091135Methylin 10 MG per 5 ML Oral SolutionSY9e3c22d9-71d9-46a7-b315-8021c94c4bec32
1091135Methylin 2 MG/ML Oral SolutionSY9e3c22d9-71d9-46a7-b315-8021c94c4bec32
1091343Methylin 5 MG per 5 ML Oral SolutionSY9e3c22d9-71d9-46a7-b315-8021c94c4bec32
1091341methylphenidate HCl 10 MG per 10 ML Oral SolutionSY9e3c22d9-71d9-46a7-b315-8021c94c4bec32
1091133methylphenidate HCl 10 MG per 5 ML Oral SolutionSY9e3c22d9-71d9-46a7-b315-8021c94c4bec32
1091341methylphenidate HCl 5 MG per 5 ML Oral SolutionSY9e3c22d9-71d9-46a7-b315-8021c94c4bec32
1091133methylphenidate hydrochloride 10 MG per 5 ML Oral SolutionSY9e3c22d9-71d9-46a7-b315-8021c94c4bec32
1091341methylphenidate hydrochloride 5 MG per 5 ML Oral SolutionSY9e3c22d9-71d9-46a7-b315-8021c94c4bec32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59630-750-5059630075050500 mL in 1 BOTTLE (59630-750-50) 500 ml2002-12-190000-00-00NoNoCurrent