NDC 54868-5682 - FocalinXR

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
54868-5682
Package NDCs from labels
54868-5682-0, 54868-5682-1
Manufacturer
Physicians Total Care, Inc.
Effective date
2010-11-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
FocalinXR - Physicians Total Care, Inc.Physicians Total Care, Inc.2010-11-11HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54868-5682-0FocalinXR30 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE302
54868-5682-1FocalinXR10 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54868-5682FOCALINXR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]22 package rows20110314_00f1d83e-93cc-4bbe-9c3b-c488062271ab.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54868-5682-0EA - Each54868-5682611f284f-9dea-45b3-9e1d-68b43f63953f12012-07-24
54868-5682-1EA - Each54868-5682fcba02e4-271f-4549-9691-0a570f374dc512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXMETHYLPHENIDATE HYDROCHLORIDEACTIVE INGREDIENT1678OK0E08FOCALINXR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
DEXMETHYLPHENIDATEACTIVE MOIETYM32RH9MFGPFOCALINXR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2FOCALINXR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKFOCALINXR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFOCALINXR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LFOCALINXR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AFOCALINXR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UFOCALINXR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFOCALINXR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMFOCALINXR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2