FDA.reportPublic FDA data

Ritalin

Product NDC
0078-0439
11-digit product format
000780439
Labeler code
0078
Product ID
0078-0439_00db4d6e-410b-43a1-ab5e-7047f525e68d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methylphenidate hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA010187
Marketing category
NDA
Marketing start
1955-12-31
Marketing end
2026-08-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ritalin

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4B3SC438HI
Rxcui1091150, 1091379, 1091392, 1091395, 1091497, 1091500

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
0078-0439-05Ritalin100 in 1 BOTTLETABLET10032

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0439-05EA - Each0078-0439280bffcf-1737-4aeb-a3ad-abacad1f5b7d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHYLPHENIDATE HYDROCHLORIDEACTIVE INGREDIENT4B3SC438HIRITALIN (METHYLPHENIDATE HYDROCHLORIDE) TABLET RITALIN SR (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]16
METHYLPHENIDATEACTIVE MOIETY207ZZ9QZ49RITALIN (METHYLPHENIDATE HYDROCHLORIDE) TABLET RITALIN SR (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]16
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SRITALIN (METHYLPHENIDATE HYDROCHLORIDE) TABLET RITALIN SR (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]16
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GRITALIN (METHYLPHENIDATE HYDROCHLORIDE) TABLET RITALIN SR (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]16
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SRITALIN (METHYLPHENIDATE HYDROCHLORIDE) TABLET RITALIN SR (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]16
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GRITALIN (METHYLPHENIDATE HYDROCHLORIDE) TABLET RITALIN SR (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]16
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RITALIN (METHYLPHENIDATE HYDROCHLORIDE) TABLET RITALIN SR (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]16
METHYL ALCOHOLINACTIVE INGREDIENTY4S76JWI15RITALIN (METHYLPHENIDATE HYDROCHLORIDE) TABLET RITALIN SR (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]16
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPRITALIN (METHYLPHENIDATE HYDROCHLORIDE) TABLET RITALIN SR (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]16
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ARITALIN (METHYLPHENIDATE HYDROCHLORIDE) TABLET RITALIN SR (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]16
POVIDONESINACTIVE INGREDIENTFZ989GH94ERITALIN (METHYLPHENIDATE HYDROCHLORIDE) TABLET RITALIN SR (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]16
SUCROSEINACTIVE INGREDIENTC151H8M554RITALIN (METHYLPHENIDATE HYDROCHLORIDE) TABLET RITALIN SR (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]16
TALCINACTIVE INGREDIENT7SEV7J4R1URITALIN (METHYLPHENIDATE HYDROCHLORIDE) TABLET RITALIN SR (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]16
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRITALIN (METHYLPHENIDATE HYDROCHLORIDE) TABLET RITALIN SR (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]16
TRAGACANTHINACTIVE INGREDIENT2944357O2ORITALIN (METHYLPHENIDATE HYDROCHLORIDE) TABLET RITALIN SR (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]16
ZEININACTIVE INGREDIENT80N308T1NNRITALIN (METHYLPHENIDATE HYDROCHLORIDE) TABLET RITALIN SR (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]16
METHYLPHENIDATE HYDROCHLORIDEACTIVE INGREDIENT4B3SC438HIRITALIN (METHYLPHENIDATE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
METHYLPHENIDATEACTIVE MOIETY207ZZ9QZ49RITALIN (METHYLPHENIDATE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GRITALIN (METHYLPHENIDATE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XRITALIN (METHYLPHENIDATE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RITALIN (METHYLPHENIDATE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ARITALIN (METHYLPHENIDATE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554RITALIN (METHYLPHENIDATE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1URITALIN (METHYLPHENIDATE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
TRAGACANTHINACTIVE INGREDIENT2944357O2ORITALIN (METHYLPHENIDATE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0439RITALIN (METHYLPHENIDATE HYDROCHLORIDE) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]32Current NDC, Legacy NDC, 1 package rows20250217_c0bf0835-6a2f-4067-a158-8b86c4b0668a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1091150methylphenidate HCl 10 MG Oral TabletPSNc0bf0835-6a2f-4067-a158-8b86c4b0668a32
1091392methylphenidate HCl 20 MG Oral TabletPSNc0bf0835-6a2f-4067-a158-8b86c4b0668a32
1091497methylphenidate HCl 5 MG Oral TabletPSNc0bf0835-6a2f-4067-a158-8b86c4b0668a32
1091379Ritalin HCl 10 MG Oral TabletPSNc0bf0835-6a2f-4067-a158-8b86c4b0668a32
1091395Ritalin HCl 20 MG Oral TabletPSNc0bf0835-6a2f-4067-a158-8b86c4b0668a32
1091500Ritalin HCl 5 MG Oral TabletPSNc0bf0835-6a2f-4067-a158-8b86c4b0668a32
1091379methylphenidate hydrochloride 10 MG Oral Tablet [Ritalin]SBDc0bf0835-6a2f-4067-a158-8b86c4b0668a32
1091395methylphenidate hydrochloride 20 MG Oral Tablet [Ritalin]SBDc0bf0835-6a2f-4067-a158-8b86c4b0668a32
1091500methylphenidate hydrochloride 5 MG Oral Tablet [Ritalin]SBDc0bf0835-6a2f-4067-a158-8b86c4b0668a32
1091150methylphenidate hydrochloride 10 MG Oral TabletSCDc0bf0835-6a2f-4067-a158-8b86c4b0668a32
1091392methylphenidate hydrochloride 20 MG Oral TabletSCDc0bf0835-6a2f-4067-a158-8b86c4b0668a32
1091497methylphenidate hydrochloride 5 MG Oral TabletSCDc0bf0835-6a2f-4067-a158-8b86c4b0668a32
1091379Ritalin 10 MG Oral TabletSYc0bf0835-6a2f-4067-a158-8b86c4b0668a32
1091395Ritalin 20 MG Oral TabletSYc0bf0835-6a2f-4067-a158-8b86c4b0668a32
1091500Ritalin 5 MG Oral TabletSYc0bf0835-6a2f-4067-a158-8b86c4b0668a32
1091392methylphenidate HCl 20 MG Oral TabletPSNcd83fc91-47a3-4be4-9727-caf9ec0371e81
1091497methylphenidate HCl 5 MG Oral TabletPSNcd83fc91-47a3-4be4-9727-caf9ec0371e81
1091395Ritalin HCl 20 MG Oral TabletPSNcd83fc91-47a3-4be4-9727-caf9ec0371e81
1091500Ritalin HCl 5 MG Oral TabletPSNcd83fc91-47a3-4be4-9727-caf9ec0371e81
1091395methylphenidate hydrochloride 20 MG Oral Tablet [Ritalin]SBDcd83fc91-47a3-4be4-9727-caf9ec0371e81
1091500methylphenidate hydrochloride 5 MG Oral Tablet [Ritalin]SBDcd83fc91-47a3-4be4-9727-caf9ec0371e81
1091392methylphenidate hydrochloride 20 MG Oral TabletSCDcd83fc91-47a3-4be4-9727-caf9ec0371e81
1091497methylphenidate hydrochloride 5 MG Oral TabletSCDcd83fc91-47a3-4be4-9727-caf9ec0371e81
1091395Ritalin 20 MG Oral TabletSYcd83fc91-47a3-4be4-9727-caf9ec0371e81
1091500Ritalin 5 MG Oral TabletSYcd83fc91-47a3-4be4-9727-caf9ec0371e81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0439-0500078043905100 TABLET in 1 BOTTLE (0078-0439-05) 100 tablet1955-12-312026-07-31NoNoCurrent