FDA.reportPublic FDA data

Focalin

Product NDC
0078-0434
11-digit product format
000780434
Labeler code
0078
Product ID
0078-0434_fd5dd3b3-6bdf-437e-a763-1a07f9631121
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dexmethylphenidate hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA021802
Marketing category
NDA
Marketing start
2005-05-31
Marketing end
2026-12-31
Substance
DEXMETHYLPHENIDATE HYDROCHLORIDE
Active strength
40 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
Brand name suffix
XR

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXMETHYLPHENIDATE HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1678OK0E08
Rxcui899439, 899441, 899461, 899463, 899485, 899487, 899495, 899497, 899511, 899513, 1006608, 1006610, 1101926, 1101928, 1101932, 1101934

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
0078-0434-05FocalinXR100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10036

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0434-05EA - Each0078-0434a482cb43-10c2-4ebe-8139-ef55273dd69a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXMETHYLPHENIDATE HYDROCHLORIDEACTIVE INGREDIENT1678OK0E08FOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]21
DEXMETHYLPHENIDATEACTIVE MOIETYM32RH9MFGPFOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]21
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2FOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]21
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKFOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]21
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]21
GELATININACTIVE INGREDIENT2G86QN327LFOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]21
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]21
TALCINACTIVE INGREDIENT7SEV7J4R1UFOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]21
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]21
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMFOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0434FOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]34Current NDC, Legacy NDC, 1 package rows20231030_1a1da905-42a0-4748-9c39-67eca45deccc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
899439dexmethylphenidate HCl 10 MG 24HR Extended Release Oral CapsulePSN1a1da905-42a0-4748-9c39-67eca45deccc36
899461dexmethylphenidate HCl 15 MG 24HR Extended Release Oral CapsulePSN1a1da905-42a0-4748-9c39-67eca45deccc36
899485dexmethylphenidate HCl 20 MG 24HR Extended Release Oral CapsulePSN1a1da905-42a0-4748-9c39-67eca45deccc36
1101926dexmethylphenidate HCl 25 MG 24HR Extended Release Oral CapsulePSN1a1da905-42a0-4748-9c39-67eca45deccc36
899495dexmethylphenidate HCl 30 MG 24HR Extended Release Oral CapsulePSN1a1da905-42a0-4748-9c39-67eca45deccc36
1101932dexmethylphenidate HCl 35 MG 24HR Extended Release Oral CapsulePSN1a1da905-42a0-4748-9c39-67eca45deccc36
1006608dexmethylphenidate HCl 40 MG 24HR Extended Release Oral CapsulePSN1a1da905-42a0-4748-9c39-67eca45deccc36
899511dexmethylphenidate HCl 5 MG 24HR Extended Release Oral CapsulePSN1a1da905-42a0-4748-9c39-67eca45deccc36
899441Focalin XR 10 MG 24HR Extended Release Oral CapsulePSN1a1da905-42a0-4748-9c39-67eca45deccc36
899463Focalin XR 15 MG 24HR Extended Release Oral CapsulePSN1a1da905-42a0-4748-9c39-67eca45deccc36
899487Focalin XR 20 MG 24HR Extended Release Oral CapsulePSN1a1da905-42a0-4748-9c39-67eca45deccc36
1101928Focalin XR 25 MG 24HR Extended Release Oral CapsulePSN1a1da905-42a0-4748-9c39-67eca45deccc36
899497Focalin XR 30 MG 24HR Extended Release Oral CapsulePSN1a1da905-42a0-4748-9c39-67eca45deccc36
1101934Focalin XR 35 MG 24HR Extended Release Oral CapsulePSN1a1da905-42a0-4748-9c39-67eca45deccc36
1006610Focalin XR 40 MG 24HR Extended Release Oral CapsulePSN1a1da905-42a0-4748-9c39-67eca45deccc36
899513Focalin XR 5 MG 24HR Extended Release Oral CapsulePSN1a1da905-42a0-4748-9c39-67eca45deccc36
89944124 HR dexmethylphenidate hydrochloride 10 MG Extended Release Oral Capsule [Focalin]SBD1a1da905-42a0-4748-9c39-67eca45deccc36
89946324 HR dexmethylphenidate hydrochloride 15 MG Extended Release Oral Capsule [Focalin]SBD1a1da905-42a0-4748-9c39-67eca45deccc36
89948724 HR dexmethylphenidate hydrochloride 20 MG Extended Release Oral Capsule [Focalin]SBD1a1da905-42a0-4748-9c39-67eca45deccc36
110192824 HR dexmethylphenidate hydrochloride 25 MG Extended Release Oral Capsule [Focalin]SBD1a1da905-42a0-4748-9c39-67eca45deccc36
89949724 HR dexmethylphenidate hydrochloride 30 MG Extended Release Oral Capsule [Focalin]SBD1a1da905-42a0-4748-9c39-67eca45deccc36
110193424 HR dexmethylphenidate hydrochloride 35 MG Extended Release Oral Capsule [Focalin]SBD1a1da905-42a0-4748-9c39-67eca45deccc36
100661024 HR dexmethylphenidate hydrochloride 40 MG Extended Release Oral Capsule [Focalin]SBD1a1da905-42a0-4748-9c39-67eca45deccc36
89951324 HR dexmethylphenidate hydrochloride 5 MG Extended Release Oral Capsule [Focalin]SBD1a1da905-42a0-4748-9c39-67eca45deccc36
89943924 HR dexmethylphenidate hydrochloride 10 MG Extended Release Oral CapsuleSCD1a1da905-42a0-4748-9c39-67eca45deccc36
89946124 HR dexmethylphenidate hydrochloride 15 MG Extended Release Oral CapsuleSCD1a1da905-42a0-4748-9c39-67eca45deccc36
89948524 HR dexmethylphenidate hydrochloride 20 MG Extended Release Oral CapsuleSCD1a1da905-42a0-4748-9c39-67eca45deccc36
110192624 HR dexmethylphenidate hydrochloride 25 MG Extended Release Oral CapsuleSCD1a1da905-42a0-4748-9c39-67eca45deccc36
89949524 HR dexmethylphenidate hydrochloride 30 MG Extended Release Oral CapsuleSCD1a1da905-42a0-4748-9c39-67eca45deccc36
110193224 HR dexmethylphenidate hydrochloride 35 MG Extended Release Oral CapsuleSCD1a1da905-42a0-4748-9c39-67eca45deccc36
100660824 HR dexmethylphenidate hydrochloride 40 MG Extended Release Oral CapsuleSCD1a1da905-42a0-4748-9c39-67eca45deccc36
89951124 HR dexmethylphenidate hydrochloride 5 MG Extended Release Oral CapsuleSCD1a1da905-42a0-4748-9c39-67eca45deccc36
89944124 HR Focalin 10 MG Extended Release Oral CapsuleSY1a1da905-42a0-4748-9c39-67eca45deccc36
89946324 HR Focalin 15 MG Extended Release Oral CapsuleSY1a1da905-42a0-4748-9c39-67eca45deccc36
89948724 HR Focalin 20 MG Extended Release Oral CapsuleSY1a1da905-42a0-4748-9c39-67eca45deccc36
110192824 HR Focalin 25 MG Extended Release Oral CapsuleSY1a1da905-42a0-4748-9c39-67eca45deccc36
89949724 HR Focalin 30 MG Extended Release Oral CapsuleSY1a1da905-42a0-4748-9c39-67eca45deccc36
110193424 HR Focalin 35 MG Extended Release Oral CapsuleSY1a1da905-42a0-4748-9c39-67eca45deccc36
100661024 HR Focalin 40 MG Extended Release Oral CapsuleSY1a1da905-42a0-4748-9c39-67eca45deccc36
89951324 HR Focalin 5 MG Extended Release Oral CapsuleSY1a1da905-42a0-4748-9c39-67eca45deccc36
899439dexmethylphenidate hydrochloride 10 MG 24 HR Extended Release Oral CapsuleSY1a1da905-42a0-4748-9c39-67eca45deccc36
899461dexmethylphenidate hydrochloride 15 MG 24 HR Extended Release Oral CapsuleSY1a1da905-42a0-4748-9c39-67eca45deccc36
899485dexmethylphenidate hydrochloride 20 MG 24 HR Extended Release Oral CapsuleSY1a1da905-42a0-4748-9c39-67eca45deccc36
1101926dexmethylphenidate hydrochloride 25 MG 24 HR Extended Release Oral CapsuleSY1a1da905-42a0-4748-9c39-67eca45deccc36
899495dexmethylphenidate hydrochloride 30 MG 24 HR Extended Release Oral CapsuleSY1a1da905-42a0-4748-9c39-67eca45deccc36
1101932dexmethylphenidate hydrochloride 35 MG 24 HR Extended Release Oral CapsuleSY1a1da905-42a0-4748-9c39-67eca45deccc36
1006608dexmethylphenidate hydrochloride 40 MG 24 HR Extended Release Oral CapsuleSY1a1da905-42a0-4748-9c39-67eca45deccc36
899511dexmethylphenidate hydrochloride 5 MG 24 HR Extended Release Oral CapsuleSY1a1da905-42a0-4748-9c39-67eca45deccc36
899441Focalin XR 10 MG 24 HR Extended Release Oral CapsuleSY1a1da905-42a0-4748-9c39-67eca45deccc36
899463Focalin XR 15 MG 24 HR Extended Release Oral CapsuleSY1a1da905-42a0-4748-9c39-67eca45deccc36
899487Focalin XR 20 MG 24 HR Extended Release Oral CapsuleSY1a1da905-42a0-4748-9c39-67eca45deccc36
1101928Focalin XR 25 MG 24 HR Extended Release Oral CapsuleSY1a1da905-42a0-4748-9c39-67eca45deccc36
899497Focalin XR 30 MG 24 HR Extended Release Oral CapsuleSY1a1da905-42a0-4748-9c39-67eca45deccc36
1101934Focalin XR 35 MG 24 HR Extended Release Oral CapsuleSY1a1da905-42a0-4748-9c39-67eca45deccc36
1006610Focalin XR 40 MG 24 HR Extended Release Oral CapsuleSY1a1da905-42a0-4748-9c39-67eca45deccc36
899513Focalin XR 5 MG 24 HR Extended Release Oral CapsuleSY1a1da905-42a0-4748-9c39-67eca45deccc36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0078-0434-0500078043405100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0434-05) 2005-05-310000-00-00NoNoCurrent