FDA.reportPublic FDA data

Methylphenidate Hydrochloride

Product NDC
57664-228
11-digit product format
576640228
Labeler code
57664
Product ID
57664-228_2f1c1df8-491a-08c9-e063-6394a90a1d06
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylphenidate Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA090710
Marketing category
ANDA
Marketing start
2013-08-16
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
5 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4B3SC438HI
Rxcui1091150, 1091392, 1091497

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
143536be-f21a-464c-bc5a-163f5c171815Product name220250626
fd4d0878-dcea-3832-288e-e3bbbbe580ffProduct name920240516
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
57664-228-08Methylphenidate Hydrochloride100 in 1 BOTTLETABLET10016
57664-228-13Methylphenidate Hydrochloride500 in 1 BOTTLETABLET50016
57664-228-18Methylphenidate Hydrochloride1000 in 1 BOTTLETABLET100016
57664-228-83Methylphenidate Hydrochloride30 in 1 BOTTLETABLET3016
57664-228-88Methylphenidate Hydrochloride100 in 1 BOTTLETABLET10016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-228-88EA - Each57664-22864700f18-999f-4bd0-a497-65abe43bb92712013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHYLPHENIDATE HYDROCHLORIDEACTIVE INGREDIENT4B3SC438HIMETHYLPHENIDATE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]8
METHYLPHENIDATEACTIVE MOIETY207ZZ9QZ49METHYLPHENIDATE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]8
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMETHYLPHENIDATE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]8
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMETHYLPHENIDATE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]8
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMETHYLPHENIDATE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]8
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8METHYLPHENIDATE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETHYLPHENIDATE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHYLPHENIDATE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]8
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BMETHYLPHENIDATE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]8
TALCINACTIVE INGREDIENT7SEV7J4R1UMETHYLPHENIDATE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57664-228METHYLPHENIDATE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]16Current NDC, Legacy NDC, 5 package rows20250228_1a89b390-0cd5-45cb-9e70-20de44652c56.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1091497methylphenidate HCl 5 MG Oral TabletPSN5a22dd9b-9b48-4c96-8b20-0d20131521dc102
1091497methylphenidate hydrochloride 5 MG Oral TabletSCD5a22dd9b-9b48-4c96-8b20-0d20131521dc102
1091150methylphenidate HCl 10 MG Oral TabletPSN1a89b390-0cd5-45cb-9e70-20de44652c5616
1091392methylphenidate HCl 20 MG Oral TabletPSN1a89b390-0cd5-45cb-9e70-20de44652c5616
1091497methylphenidate HCl 5 MG Oral TabletPSN1a89b390-0cd5-45cb-9e70-20de44652c5616
1091150methylphenidate hydrochloride 10 MG Oral TabletSCD1a89b390-0cd5-45cb-9e70-20de44652c5616
1091392methylphenidate hydrochloride 20 MG Oral TabletSCD1a89b390-0cd5-45cb-9e70-20de44652c5616
1091497methylphenidate hydrochloride 5 MG Oral TabletSCD1a89b390-0cd5-45cb-9e70-20de44652c5616
1091497methylphenidate HCl 5 MG Oral TabletPSN1c7d7e6c-4e96-4d18-8dca-203ef50766ec6
1091497methylphenidate hydrochloride 5 MG Oral TabletSCD1c7d7e6c-4e96-4d18-8dca-203ef50766ec6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57664-228-0857664022808100 TABLET in 1 BOTTLE (57664-228-08) 100 tablet2013-08-160000-00-00NoNoCurrent
57664-228-1357664022813500 TABLET in 1 BOTTLE (57664-228-13) 500 tablet2013-08-160000-00-00NoNoCurrent
57664-228-18576640228181000 TABLET in 1 BOTTLE (57664-228-18) 1000 tablet2013-08-160000-00-00NoNoCurrent
57664-228-835766402288330 TABLET in 1 BOTTLE (57664-228-83) 30 tablet2013-08-160000-00-00NoNoCurrent
57664-228-8857664022888100 TABLET in 1 BOTTLE (57664-228-88) 100 tablet2013-08-160000-00-00NoNoCurrent