FDA.reportPublic FDA data

CONCERTA

Product NDC
50458-587
11-digit product format
504580587
Labeler code
50458
Product ID
50458-587_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
54 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021121-001CONCERTAMETHYLPHENIDATE HYDROCHLORIDE18MGTABLET, EXTENDED RELEASE / ORALABRLD2000-08-01
N021121-002CONCERTAMETHYLPHENIDATE HYDROCHLORIDE36MGTABLET, EXTENDED RELEASE / ORALABRLD2000-08-01
N021121-003CONCERTAMETHYLPHENIDATE HYDROCHLORIDE54MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2000-12-08
N021121-004CONCERTAMETHYLPHENIDATE HYDROCHLORIDE27MGTABLET, EXTENDED RELEASE / ORALABRLD2002-04-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
N021121-001AB
N021121-002AB
N021121-003AB
N021121-004AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021121-001CONCERTA18MGTABLET, EXTENDED RELEASE / ORALABRLD2000-08-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021121-002CONCERTA36MGTABLET, EXTENDED RELEASE / ORALABRLD2000-08-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021121-003CONCERTA54MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2000-12-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021121-004CONCERTA27MGTABLET, EXTENDED RELEASE / ORALABRLD2002-04-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021121-001CONCERTA18MGTABLET, EXTENDED RELEASE / ORALABRLD2000-08-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021121-002CONCERTA36MGTABLET, EXTENDED RELEASE / ORALABRLD2000-08-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021121-003CONCERTA54MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2000-12-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021121-004CONCERTA27MGTABLET, EXTENDED RELEASE / ORALABRLD2002-04-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021121-001CONCERTA18MGTABLET, EXTENDED RELEASE / ORALABRLD2000-08-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021121-002CONCERTA36MGTABLET, EXTENDED RELEASE / ORALABRLD2000-08-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021121-003CONCERTA54MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2000-12-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021121-004CONCERTA27MGTABLET, EXTENDED RELEASE / ORALABRLD2002-04-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021121-001CONCERTA18MGTABLET, EXTENDED RELEASE / ORALABRLD2000-08-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021121-002CONCERTA36MGTABLET, EXTENDED RELEASE / ORALABRLD2000-08-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021121-003CONCERTA54MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2000-12-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021121-004CONCERTA27MGTABLET, EXTENDED RELEASE / ORALABRLD2002-04-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021121-001CONCERTA18MGTABLET, EXTENDED RELEASE / ORALABRLD2000-08-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021121-002CONCERTA36MGTABLET, EXTENDED RELEASE / ORALABRLD2000-08-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021121-003CONCERTA54MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2000-12-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021121-004CONCERTA27MGTABLET, EXTENDED RELEASE / ORALABRLD2002-04-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021121-001CONCERTA18MGTABLET, EXTENDED RELEASE / ORALABRLD2000-08-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021121-002CONCERTA36MGTABLET, EXTENDED RELEASE / ORALABRLD2000-08-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021121-003CONCERTA54MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2000-12-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021121-004CONCERTA27MGTABLET, EXTENDED RELEASE / ORALABRLD2002-04-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021121-001CONCERTA18MGTABLET, EXTENDED RELEASE / ORALABRLD2000-08-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021121-002CONCERTA36MGTABLET, EXTENDED RELEASE / ORALABRLD2000-08-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021121-003CONCERTA54MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2000-12-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021121-004CONCERTA27MGTABLET, EXTENDED RELEASE / ORALABRLD2002-04-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021121-001CONCERTA18MGTABLET, EXTENDED RELEASE / ORALABRLD2000-08-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021121-002CONCERTA36MGTABLET, EXTENDED RELEASE / ORALABRLD2000-08-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021121-003CONCERTA54MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2000-12-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021121-004CONCERTA27MGTABLET, EXTENDED RELEASE / ORALABRLD2002-04-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021121-001CONCERTA18MGTABLET, EXTENDED RELEASE / ORALABRLD2000-08-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021121-002CONCERTA36MGTABLET, EXTENDED RELEASE / ORALABRLD2000-08-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021121-003CONCERTA54MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2000-12-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021121-004CONCERTA27MGTABLET, EXTENDED RELEASE / ORALABRLD2002-04-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021121-001CONCERTA18MGTABLET, EXTENDED RELEASE / ORALABRLD2000-08-01d06236e962d9…
2024-10-29 15:01 UTC2024-10N021121-002CONCERTA36MGTABLET, EXTENDED RELEASE / ORALABRLD2000-08-01d06236e962d9…
2024-10-29 15:01 UTC2024-10N021121-003CONCERTA54MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2000-12-08d06236e962d9…
2024-10-29 15:01 UTC2024-10N021121-004CONCERTA27MGTABLET, EXTENDED RELEASE / ORALABRLD2002-04-01d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N021121-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021121-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021121-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021121-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021121-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021121-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021121-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021121-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021121-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021121-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021121-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021121-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021121-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021121-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021121-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021121-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021121-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021121-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021121-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021121-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021121-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021121-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021121-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021121-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021121-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021121-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021121-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021121-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021121-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021121-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021121-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021121-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021121-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021121-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021121-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021121-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021121-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021121-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021121-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021121-004AB1d06236e962d9…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE54 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4B3SC438HIInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1091155Internal RxNorm lookup
1091157Internal RxNorm lookup
1091170Internal RxNorm lookup
1091172Internal RxNorm lookup
1091185Internal RxNorm lookup
1091187Internal RxNorm lookup
1091210Internal RxNorm lookup
1091212Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1a88218c-5b18-4220-8f56-526de1a276cdAvailable on FDA.report

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
50458-587-01CONCERTA100 in 1 BOTTLETABLET, EXTENDED RELEASE10030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50458-587-01EA - Each50458-587c9560ae3-0fbe-4fa5-b2bb-5b37630b61c212012-07-24

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
50458-587CONCERTA (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]27Current NDC, Legacy NDC, 1 package rows20241004_1a88218c-5b18-4220-8f56-526de1a276cd.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CONCERTAMETHYLPHENIDATE HYDROCHLORIDEJanssen Pharmaceuticals, Inc.1a88218c-5b18-4220-8f56-526de1a276cd2026-04-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021121
application number: NDA021121
ndc (product): 50458-587

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
50458-587-0150458058701100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-587-01) 2000-08-010000-00-00NoNoCurrent