FDA.reportPublic FDA data

CONCERTA

Product NDC
50458-588
11-digit product format
504580588
Labeler code
50458
Product ID
50458-588_64d7c1e1-e7ed-4d74-a44d-13b4da64af9a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylphenidate hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Janssen Pharmaceuticals, Inc.
Application
NDA021121
Marketing category
NDA
Marketing start
2000-08-01
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
27 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CONCERTA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE27 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4B3SC438HI
Rxcui1091155, 1091157, 1091170, 1091172, 1091185, 1091187, 1091210, 1091212

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
143536be-f21a-464c-bc5a-163f5c171815Product name220250626
fd4d0878-dcea-3832-288e-e3bbbbe580ffProduct name920240516
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
435f0341-cf24-41d5-8fbf-c909821e5596Product name120230313
c9b6eabb-08d7-bb2d-e81a-06be3590b436Product name220221216
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
67aa32c6-44f4-50de-64dd-643e8caf420dProduct name620210622
50b24f34-96fa-4f1e-b262-b0baf4a4a440Product name420210513
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
cf83c421-eebe-4de2-b1a2-fd96e3dbfcf8Product name120200128
166d1d2d-dd55-4fdf-82e2-b83a3c5347c1Product name120190828
343a61d5-785d-cc27-a43a-0779da054d88Product name320190828
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
7607489b-cd15-3103-f3b1-d4283574d250Product name220190614
407f0cce-da29-4050-a512-2cabe9e5692dProduct name920190611
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
f7f4bf1e-7c67-46c6-8c42-9beb1a06b38eProduct name220190415
190572d9-6c7b-4b40-8172-c1b5f802c20fProduct name120180724
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
2948856e-f76e-d380-d9ed-b317efafbc98Product name520180423
c0aa09de-7aa1-4a98-8f70-62ec3c97c695Product name120170803
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
3317aade-2d6e-f159-9fe6-e8385a825178Product name320160829
0fe52203-83a7-4fed-a91f-8e47a22cf1d3Product name120160111
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50458-588-01CONCERTA100 in 1 BOTTLETABLET, EXTENDED RELEASE10030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50458-588-01EA - Each50458-588fc19b59d-4a92-4758-ac78-b409e8ba163f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Methylphenidate hydrochlorideACTIVE INGREDIENT4B3SC438HICONCERTA (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]14
MethylphenidateACTIVE MOIETY207ZZ9QZ49CONCERTA (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]14
butylated hydroxytolueneINACTIVE INGREDIENT1P9D0Z171KCONCERTA (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]14
carnauba waxINACTIVE INGREDIENTR12CBM0EIZCONCERTA (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]14
cellulose acetateINACTIVE INGREDIENT3J2P07GVB6CONCERTA (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]14
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357CONCERTA (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]14
hypromellosesINACTIVE INGREDIENT3NXW29V3WOCONCERTA (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]14
lactoseINACTIVE INGREDIENTJ2B2A4N98GCONCERTA (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]14
phosphoric acidINACTIVE INGREDIENTE4GA8884NNCONCERTA (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]14
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ACONCERTA (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]14
povidonesINACTIVE INGREDIENTFZ989GH94ECONCERTA (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]14
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CONCERTA (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]14
sodium chlorideINACTIVE INGREDIENT451W47IQ8XCONCERTA (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]14
stearic acidINACTIVE INGREDIENT4ELV7Z65APCONCERTA (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]14
succinic acidINACTIVE INGREDIENTAB6MNQ6J6LCONCERTA (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]14
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCONCERTA (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]14
triacetinINACTIVE INGREDIENTXHX3C3X673CONCERTA (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]14
METHYLPHENIDATE HYDROCHLORIDEACTIVE INGREDIENT4B3SC438HICONCERTA (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
METHYLPHENIDATEACTIVE MOIETY207ZZ9QZ49CONCERTA (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KCONCERTA (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZCONCERTA (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE ACETATEINACTIVE INGREDIENT3J2P07GVB6CONCERTA (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CONCERTA (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCONCERTA (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GCONCERTA (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNCONCERTA (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ACONCERTA (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ECONCERTA (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CONCERTA (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCONCERTA (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCONCERTA (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
SUCCINIC ACIDINACTIVE INGREDIENTAB6MNQ6J6LCONCERTA (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCONCERTA (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
TRIACETININACTIVE INGREDIENTXHX3C3X673CONCERTA (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50458-588CONCERTA (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]27Current NDC, Legacy NDC, 1 package rows20241004_1a88218c-5b18-4220-8f56-526de1a276cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1091157CONCERTA 18 MG 24HR Extended Release Oral TabletPSN1a88218c-5b18-4220-8f56-526de1a276cd30
1091172CONCERTA 27 MG 24HR Extended Release Oral TabletPSN1a88218c-5b18-4220-8f56-526de1a276cd30
1091187CONCERTA 36 MG 24HR Extended Release Oral TabletPSN1a88218c-5b18-4220-8f56-526de1a276cd30
1091212CONCERTA 54 MG 24HR Extended Release Oral TabletPSN1a88218c-5b18-4220-8f56-526de1a276cd30
1091155methylphenidate HCl 18 MG 24HR Extended Release Oral TabletPSN1a88218c-5b18-4220-8f56-526de1a276cd30
1091170methylphenidate HCl 27 MG 24HR Extended Release Oral TabletPSN1a88218c-5b18-4220-8f56-526de1a276cd30
1091185methylphenidate HCl 36 MG 24HR Extended Release Oral TabletPSN1a88218c-5b18-4220-8f56-526de1a276cd30
1091210methylphenidate HCl 54 MG 24HR Extended Release Oral TabletPSN1a88218c-5b18-4220-8f56-526de1a276cd30
109115724 HR methylphenidate hydrochloride 18 MG Extended Release Oral Tablet [Concerta]SBD1a88218c-5b18-4220-8f56-526de1a276cd30
109117224 HR methylphenidate hydrochloride 27 MG Extended Release Oral Tablet [Concerta]SBD1a88218c-5b18-4220-8f56-526de1a276cd30
109118724 HR methylphenidate hydrochloride 36 MG Extended Release Oral Tablet [Concerta]SBD1a88218c-5b18-4220-8f56-526de1a276cd30
109121224 HR methylphenidate hydrochloride 54 MG Extended Release Oral Tablet [Concerta]SBD1a88218c-5b18-4220-8f56-526de1a276cd30
109115524 HR methylphenidate hydrochloride 18 MG Extended Release Oral TabletSCD1a88218c-5b18-4220-8f56-526de1a276cd30
109117024 HR methylphenidate hydrochloride 27 MG Extended Release Oral TabletSCD1a88218c-5b18-4220-8f56-526de1a276cd30
109118524 HR methylphenidate hydrochloride 36 MG Extended Release Oral TabletSCD1a88218c-5b18-4220-8f56-526de1a276cd30
109121024 HR methylphenidate hydrochloride 54 MG Extended Release Oral TabletSCD1a88218c-5b18-4220-8f56-526de1a276cd30
109115724 HR Concerta 18 MG Extended Release Oral TabletSY1a88218c-5b18-4220-8f56-526de1a276cd30
109117224 HR Concerta 27 MG Extended Release Oral TabletSY1a88218c-5b18-4220-8f56-526de1a276cd30
109118724 HR Concerta 36 MG Extended Release Oral TabletSY1a88218c-5b18-4220-8f56-526de1a276cd30
109121224 HR Concerta 54 MG Extended Release Oral TabletSY1a88218c-5b18-4220-8f56-526de1a276cd30
1091157Concerta 18 MG 24 HR Extended Release Oral TabletSY1a88218c-5b18-4220-8f56-526de1a276cd30
1091172Concerta 27 MG 24 HR Extended Release Oral TabletSY1a88218c-5b18-4220-8f56-526de1a276cd30
1091187Concerta 36 MG 24 HR Extended Release Oral TabletSY1a88218c-5b18-4220-8f56-526de1a276cd30
1091212Concerta 54 MG 24 HR Extended Release Oral TabletSY1a88218c-5b18-4220-8f56-526de1a276cd30
1091155methylphenidate hydrochloride 18 MG 24 HR Extended Release Oral TabletSY1a88218c-5b18-4220-8f56-526de1a276cd30
1091170methylphenidate hydrochloride 27 MG 24 HR Extended Release Oral TabletSY1a88218c-5b18-4220-8f56-526de1a276cd30
1091185methylphenidate hydrochloride 36 MG 24 HR Extended Release Oral TabletSY1a88218c-5b18-4220-8f56-526de1a276cd30
1091210methylphenidate hydrochloride 54 MG 24 HR Extended Release Oral TabletSY1a88218c-5b18-4220-8f56-526de1a276cd30
1091157CONCERTA 18 MG 24HR Extended Release Oral TabletPSNf63155b9-ea71-4a30-be32-37173f87bcbf1
1091172CONCERTA 27 MG 24HR Extended Release Oral TabletPSNf63155b9-ea71-4a30-be32-37173f87bcbf1
1091187CONCERTA 36 MG 24HR Extended Release Oral TabletPSNf63155b9-ea71-4a30-be32-37173f87bcbf1
1091212CONCERTA 54 MG 24HR Extended Release Oral TabletPSNf63155b9-ea71-4a30-be32-37173f87bcbf1
1091155methylphenidate HCl 18 MG 24HR Extended Release Oral TabletPSNf63155b9-ea71-4a30-be32-37173f87bcbf1
1091170methylphenidate HCl 27 MG 24HR Extended Release Oral TabletPSNf63155b9-ea71-4a30-be32-37173f87bcbf1
1091185methylphenidate HCl 36 MG 24HR Extended Release Oral TabletPSNf63155b9-ea71-4a30-be32-37173f87bcbf1
1091210methylphenidate HCl 54 MG 24HR Extended Release Oral TabletPSNf63155b9-ea71-4a30-be32-37173f87bcbf1
109115724 HR methylphenidate hydrochloride 18 MG Extended Release Oral Tablet [Concerta]SBDf63155b9-ea71-4a30-be32-37173f87bcbf1
109117224 HR methylphenidate hydrochloride 27 MG Extended Release Oral Tablet [Concerta]SBDf63155b9-ea71-4a30-be32-37173f87bcbf1
109118724 HR methylphenidate hydrochloride 36 MG Extended Release Oral Tablet [Concerta]SBDf63155b9-ea71-4a30-be32-37173f87bcbf1
109121224 HR methylphenidate hydrochloride 54 MG Extended Release Oral Tablet [Concerta]SBDf63155b9-ea71-4a30-be32-37173f87bcbf1
109115524 HR methylphenidate hydrochloride 18 MG Extended Release Oral TabletSCDf63155b9-ea71-4a30-be32-37173f87bcbf1
109117024 HR methylphenidate hydrochloride 27 MG Extended Release Oral TabletSCDf63155b9-ea71-4a30-be32-37173f87bcbf1
109118524 HR methylphenidate hydrochloride 36 MG Extended Release Oral TabletSCDf63155b9-ea71-4a30-be32-37173f87bcbf1
109121024 HR methylphenidate hydrochloride 54 MG Extended Release Oral TabletSCDf63155b9-ea71-4a30-be32-37173f87bcbf1
109115724 HR Concerta 18 MG Extended Release Oral TabletSYf63155b9-ea71-4a30-be32-37173f87bcbf1
109117224 HR Concerta 27 MG Extended Release Oral TabletSYf63155b9-ea71-4a30-be32-37173f87bcbf1
109118724 HR Concerta 36 MG Extended Release Oral TabletSYf63155b9-ea71-4a30-be32-37173f87bcbf1
109121224 HR Concerta 54 MG Extended Release Oral TabletSYf63155b9-ea71-4a30-be32-37173f87bcbf1
1091157Concerta 18 MG 24 HR Extended Release Oral TabletSYf63155b9-ea71-4a30-be32-37173f87bcbf1
1091172Concerta 27 MG 24 HR Extended Release Oral TabletSYf63155b9-ea71-4a30-be32-37173f87bcbf1
1091187Concerta 36 MG 24 HR Extended Release Oral TabletSYf63155b9-ea71-4a30-be32-37173f87bcbf1
1091212Concerta 54 MG 24 HR Extended Release Oral TabletSYf63155b9-ea71-4a30-be32-37173f87bcbf1
1091155methylphenidate hydrochloride 18 MG 24 HR Extended Release Oral TabletSYf63155b9-ea71-4a30-be32-37173f87bcbf1
1091170methylphenidate hydrochloride 27 MG 24 HR Extended Release Oral TabletSYf63155b9-ea71-4a30-be32-37173f87bcbf1
1091185methylphenidate hydrochloride 36 MG 24 HR Extended Release Oral TabletSYf63155b9-ea71-4a30-be32-37173f87bcbf1
1091210methylphenidate hydrochloride 54 MG 24 HR Extended Release Oral TabletSYf63155b9-ea71-4a30-be32-37173f87bcbf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50458-588-0150458058801100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-588-01) 2000-08-010000-00-00NoNoCurrent