FDA.reportPublic FDA data

Daytrana

Product NDC
68968-5554
11-digit product format
689685554
Labeler code
68968
Product ID
68968-5554_55f4b5f4-6d3c-4677-a94c-d47ffb59a91a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methylphenidate
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Noven Therapeutics, LLC
Application
NDA021514
Marketing category
NDA
Marketing start
2006-04-06
Substance
METHYLPHENIDATE
Active strength
20 mg/9h
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
Daytrana
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPHENIDATE20 mg/9h

Harmonized Identifiers#

Field, Values table
FieldValues
Unii207ZZ9QZ49
Rxcui753436, 753437, 753438, 753439, 753440, 753441, 753442, 753443

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
68968-5554-3Daytrana9 h in 1 PATCHPATCH929
68968-5554-3Daytrana30 in 1 CARTONPATCH3029

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68968-5554-3EA - Each68968-55547a64d1bd-8312-4ed3-bbef-5332ebaaee7412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHYLPHENIDATEACTIVE INGREDIENT207ZZ9QZ49DAYTRANA (METHYLPHENIDATE) PATCH [NOVEN THERAPEUTICS, LLC]12
METHYLPHENIDATEACTIVE MOIETY207ZZ9QZ49DAYTRANA (METHYLPHENIDATE) PATCH [NOVEN THERAPEUTICS, LLC]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68968-5554DAYTRANA (METHYLPHENIDATE) PATCH [NOVEN THERAPEUTICS, LLC]27Current NDC, Legacy NDC, 2 package rows20241212_2c312c31-3198-4775-91ab-294e0b4b9e7f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
753437Daytrana 10 MG/9HR Transdermal SystemPSN2c312c31-3198-4775-91ab-294e0b4b9e7f29
753439Daytrana 15 MG/9HR Transdermal SystemPSN2c312c31-3198-4775-91ab-294e0b4b9e7f29
753442Daytrana 20 MG/9HR Transdermal SystemPSN2c312c31-3198-4775-91ab-294e0b4b9e7f29
753443Daytrana 30 MG/9HR Transdermal SystemPSN2c312c31-3198-4775-91ab-294e0b4b9e7f29
753436methylphenidate 10 MG/9HR Transdermal SystemPSN2c312c31-3198-4775-91ab-294e0b4b9e7f29
753438methylphenidate 15 MG/9HR Transdermal SystemPSN2c312c31-3198-4775-91ab-294e0b4b9e7f29
753440methylphenidate 20 MG/9HR Transdermal SystemPSN2c312c31-3198-4775-91ab-294e0b4b9e7f29
753441methylphenidate 30 MG/9HR Transdermal SystemPSN2c312c31-3198-4775-91ab-294e0b4b9e7f29
7534379 HR methylphenidate 1.11 MG/HR Transdermal System [Daytrana]SBD2c312c31-3198-4775-91ab-294e0b4b9e7f29
7534399 HR methylphenidate 1.67 MG/HR Transdermal System [Daytrana]SBD2c312c31-3198-4775-91ab-294e0b4b9e7f29
7534429 HR methylphenidate 2.22 MG/HR Transdermal System [Daytrana]SBD2c312c31-3198-4775-91ab-294e0b4b9e7f29
7534439 HR methylphenidate 3.33 MG/HR Transdermal System [Daytrana]SBD2c312c31-3198-4775-91ab-294e0b4b9e7f29
7534369 HR methylphenidate 1.11 MG/HR Transdermal SystemSCD2c312c31-3198-4775-91ab-294e0b4b9e7f29
7534389 HR methylphenidate 1.67 MG/HR Transdermal SystemSCD2c312c31-3198-4775-91ab-294e0b4b9e7f29
7534409 HR methylphenidate 2.22 MG/HR Transdermal SystemSCD2c312c31-3198-4775-91ab-294e0b4b9e7f29
7534419 HR methylphenidate 3.33 MG/HR Transdermal SystemSCD2c312c31-3198-4775-91ab-294e0b4b9e7f29
7534379 HR Daytrana 1.11 MG/HR Transdermal SystemSY2c312c31-3198-4775-91ab-294e0b4b9e7f29
7534399 HR Daytrana 1.67 MG/HR Transdermal SystemSY2c312c31-3198-4775-91ab-294e0b4b9e7f29
7534429 HR Daytrana 2.22 MG/HR Transdermal SystemSY2c312c31-3198-4775-91ab-294e0b4b9e7f29
7534439 HR Daytrana 3.33 MG/HR Transdermal SystemSY2c312c31-3198-4775-91ab-294e0b4b9e7f29
753437Daytrana 10 MG per 9HR Transdermal PatchSY2c312c31-3198-4775-91ab-294e0b4b9e7f29
753437Daytrana 10 MG/9HR Transdermal SystemSY2c312c31-3198-4775-91ab-294e0b4b9e7f29
753439Daytrana 15 MG per 9HR Transdermal PatchSY2c312c31-3198-4775-91ab-294e0b4b9e7f29
753439Daytrana 15 MG/9HR Transdermal SystemSY2c312c31-3198-4775-91ab-294e0b4b9e7f29
753442Daytrana 20 MG per 9HR Transdermal PatchSY2c312c31-3198-4775-91ab-294e0b4b9e7f29
753442Daytrana 20 MG/9HR Transdermal SystemSY2c312c31-3198-4775-91ab-294e0b4b9e7f29
753443Daytrana 30 MG per 9HR Transdermal PatchSY2c312c31-3198-4775-91ab-294e0b4b9e7f29
753443Daytrana 30 MG/9HR Transdermal SystemSY2c312c31-3198-4775-91ab-294e0b4b9e7f29
753436methylphenidate 1.1 MG/HR 9HR Transdermal SystemSY2c312c31-3198-4775-91ab-294e0b4b9e7f29
753436methylphenidate 10 MG per 9HR Transdermal PatchSY2c312c31-3198-4775-91ab-294e0b4b9e7f29
753436methylphenidate 10 MG/9HR Transdermal SystemSY2c312c31-3198-4775-91ab-294e0b4b9e7f29
753438methylphenidate 15 MG per 9HR Transdermal PatchSY2c312c31-3198-4775-91ab-294e0b4b9e7f29
753438methylphenidate 15 MG/9HR Transdermal SystemSY2c312c31-3198-4775-91ab-294e0b4b9e7f29
753440methylphenidate 20 MG per 9HR Transdermal PatchSY2c312c31-3198-4775-91ab-294e0b4b9e7f29
753440methylphenidate 20 MG/9HR Transdermal SystemSY2c312c31-3198-4775-91ab-294e0b4b9e7f29
753441methylphenidate 30 MG per 9HR Transdermal PatchSY2c312c31-3198-4775-91ab-294e0b4b9e7f29
753441methylphenidate 30 MG/9HR Transdermal SystemSY2c312c31-3198-4775-91ab-294e0b4b9e7f29

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68968-5554-36896855540330 PATCH in 1 CARTON (68968-5554-3) / 9 h in 1 PATCH30 patch2006-04-060000-00-00NoNoCurrent