FDA.reportPublic FDA data

Focalin

Product NDC
66758-252
11-digit product format
667580252
Labeler code
66758
Product ID
66758-252_b5989bf2-41d3-4bd9-82aa-d89923911cd1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dexmethylphenidate hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Sandoz Inc
Application
NDA021278
Marketing category
NDA
Marketing start
2001-11-30
Marketing end
2027-09-30
Substance
DEXMETHYLPHENIDATE HYDROCHLORIDE
Active strength
10 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
Focalin

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXMETHYLPHENIDATE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1678OK0E08
Rxcui899518, 899519, 899548, 899549, 899557, 899559

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1ff349b0-f325-4585-9c0d-7dc58eb1bc1bProduct name120210818
7d5b6b15-5a1e-e1e5-992d-90d0701572adProduct name920210511
ccfbb2ac-2915-4b21-1d79-8a93f773e70fProduct name920200714

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66758-252-01Focalin100 in 1 BOTTLETABLET1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66758-252-01EA - Each66758-2520cc8ce51-68ab-4e14-826a-41066f27359412024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66758-252FOCALIN (DEXMETHYLPHENIDATE HYDROCHLORIDE) TABLET [SANDOZ INC]1Current NDC, 1 package rows20240711_2016f5c2-95d2-4655-af65-c588c2bf5e6d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
899548dexmethylphenidate HCl 10 MG Oral TabletPSN2016f5c2-95d2-4655-af65-c588c2bf5e6d2
899557dexmethylphenidate HCl 2.5 MG Oral TabletPSN2016f5c2-95d2-4655-af65-c588c2bf5e6d2
899518dexmethylphenidate HCl 5 MG Oral TabletPSN2016f5c2-95d2-4655-af65-c588c2bf5e6d2
899549Focalin 10 MG Oral TabletPSN2016f5c2-95d2-4655-af65-c588c2bf5e6d2
899559Focalin 2.5 MG Oral TabletPSN2016f5c2-95d2-4655-af65-c588c2bf5e6d2
899519Focalin 5 MG Oral TabletPSN2016f5c2-95d2-4655-af65-c588c2bf5e6d2
899549dexmethylphenidate hydrochloride 10 MG Oral Tablet [Focalin]SBD2016f5c2-95d2-4655-af65-c588c2bf5e6d2
899559dexmethylphenidate hydrochloride 2.5 MG Oral Tablet [Focalin]SBD2016f5c2-95d2-4655-af65-c588c2bf5e6d2
899519dexmethylphenidate hydrochloride 5 MG Oral Tablet [Focalin]SBD2016f5c2-95d2-4655-af65-c588c2bf5e6d2
899548dexmethylphenidate hydrochloride 10 MG Oral TabletSCD2016f5c2-95d2-4655-af65-c588c2bf5e6d2
899557dexmethylphenidate hydrochloride 2.5 MG Oral TabletSCD2016f5c2-95d2-4655-af65-c588c2bf5e6d2
899518dexmethylphenidate hydrochloride 5 MG Oral TabletSCD2016f5c2-95d2-4655-af65-c588c2bf5e6d2
899549Focalin (dexmethylphenidate hydrochloride 10 MG) Oral TabletSY2016f5c2-95d2-4655-af65-c588c2bf5e6d2
899559Focalin (dexmethylphenidate hydrochloride 2.5 MG) Oral TabletSY2016f5c2-95d2-4655-af65-c588c2bf5e6d2
899549Focalin 10 MG Oral TabletSY2016f5c2-95d2-4655-af65-c588c2bf5e6d2
899559Focalin 2.5 MG Oral TabletSY2016f5c2-95d2-4655-af65-c588c2bf5e6d2
899519Focalin 5 MG Oral TabletSY2016f5c2-95d2-4655-af65-c588c2bf5e6d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66758-252-0166758025201100 TABLET in 1 BOTTLE (66758-252-01) 100 tablet2024-07-122027-04-30NoNoHistorical