FDA.reportPublic FDA data

Focalin

Product NDC
66758-241
11-digit product format
667580241
Labeler code
66758
Product ID
66758-241_525ad849-4502-493d-a0a1-67cde0a207f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dexmethylphenidate hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Sandoz Inc
Application
NDA021802
Marketing category
NDA
Marketing start
2005-05-31
Substance
DEXMETHYLPHENIDATE HYDROCHLORIDE
Active strength
35 mg/1
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
Focalin
Brand name suffix
XR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXMETHYLPHENIDATE HYDROCHLORIDE35 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
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
66758-241-01FocalinXR100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1005
66758-241-31FocalinXR30 in 1 BOTTLECAPSULE, EXTENDED RELEASE305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66758-241-31EA - Each66758-241792682ca-f468-4e73-a9f4-4bc62cc34aab12025-11-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66758-241FOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [SANDOZ INC]1Current NDC, 2 package rows20241006_9cf76f62-48aa-4065-94fd-6fc910391ab5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
899439dexmethylphenidate HCl 10 MG 24HR Extended Release Oral CapsulePSN9cf76f62-48aa-4065-94fd-6fc910391ab55
899461dexmethylphenidate HCl 15 MG 24HR Extended Release Oral CapsulePSN9cf76f62-48aa-4065-94fd-6fc910391ab55
899485dexmethylphenidate HCl 20 MG 24HR Extended Release Oral CapsulePSN9cf76f62-48aa-4065-94fd-6fc910391ab55
1101926dexmethylphenidate HCl 25 MG 24HR Extended Release Oral CapsulePSN9cf76f62-48aa-4065-94fd-6fc910391ab55
899495dexmethylphenidate HCl 30 MG 24HR Extended Release Oral CapsulePSN9cf76f62-48aa-4065-94fd-6fc910391ab55
1101932dexmethylphenidate HCl 35 MG 24HR Extended Release Oral CapsulePSN9cf76f62-48aa-4065-94fd-6fc910391ab55
1006608dexmethylphenidate HCl 40 MG 24HR Extended Release Oral CapsulePSN9cf76f62-48aa-4065-94fd-6fc910391ab55
899511dexmethylphenidate HCl 5 MG 24HR Extended Release Oral CapsulePSN9cf76f62-48aa-4065-94fd-6fc910391ab55
899441Focalin XR 10 MG 24HR Extended Release Oral CapsulePSN9cf76f62-48aa-4065-94fd-6fc910391ab55
899463Focalin XR 15 MG 24HR Extended Release Oral CapsulePSN9cf76f62-48aa-4065-94fd-6fc910391ab55
899487Focalin XR 20 MG 24HR Extended Release Oral CapsulePSN9cf76f62-48aa-4065-94fd-6fc910391ab55
1101928Focalin XR 25 MG 24HR Extended Release Oral CapsulePSN9cf76f62-48aa-4065-94fd-6fc910391ab55
899497Focalin XR 30 MG 24HR Extended Release Oral CapsulePSN9cf76f62-48aa-4065-94fd-6fc910391ab55
1101934Focalin XR 35 MG 24HR Extended Release Oral CapsulePSN9cf76f62-48aa-4065-94fd-6fc910391ab55
1006610Focalin XR 40 MG 24HR Extended Release Oral CapsulePSN9cf76f62-48aa-4065-94fd-6fc910391ab55
899513Focalin XR 5 MG 24HR Extended Release Oral CapsulePSN9cf76f62-48aa-4065-94fd-6fc910391ab55
89944124 HR dexmethylphenidate hydrochloride 10 MG Extended Release Oral Capsule [Focalin]SBD9cf76f62-48aa-4065-94fd-6fc910391ab55
89946324 HR dexmethylphenidate hydrochloride 15 MG Extended Release Oral Capsule [Focalin]SBD9cf76f62-48aa-4065-94fd-6fc910391ab55
89948724 HR dexmethylphenidate hydrochloride 20 MG Extended Release Oral Capsule [Focalin]SBD9cf76f62-48aa-4065-94fd-6fc910391ab55
110192824 HR dexmethylphenidate hydrochloride 25 MG Extended Release Oral Capsule [Focalin]SBD9cf76f62-48aa-4065-94fd-6fc910391ab55
89949724 HR dexmethylphenidate hydrochloride 30 MG Extended Release Oral Capsule [Focalin]SBD9cf76f62-48aa-4065-94fd-6fc910391ab55
110193424 HR dexmethylphenidate hydrochloride 35 MG Extended Release Oral Capsule [Focalin]SBD9cf76f62-48aa-4065-94fd-6fc910391ab55
100661024 HR dexmethylphenidate hydrochloride 40 MG Extended Release Oral Capsule [Focalin]SBD9cf76f62-48aa-4065-94fd-6fc910391ab55
89951324 HR dexmethylphenidate hydrochloride 5 MG Extended Release Oral Capsule [Focalin]SBD9cf76f62-48aa-4065-94fd-6fc910391ab55
89943924 HR dexmethylphenidate hydrochloride 10 MG Extended Release Oral CapsuleSCD9cf76f62-48aa-4065-94fd-6fc910391ab55
89946124 HR dexmethylphenidate hydrochloride 15 MG Extended Release Oral CapsuleSCD9cf76f62-48aa-4065-94fd-6fc910391ab55
89948524 HR dexmethylphenidate hydrochloride 20 MG Extended Release Oral CapsuleSCD9cf76f62-48aa-4065-94fd-6fc910391ab55
110192624 HR dexmethylphenidate hydrochloride 25 MG Extended Release Oral CapsuleSCD9cf76f62-48aa-4065-94fd-6fc910391ab55
89949524 HR dexmethylphenidate hydrochloride 30 MG Extended Release Oral CapsuleSCD9cf76f62-48aa-4065-94fd-6fc910391ab55
110193224 HR dexmethylphenidate hydrochloride 35 MG Extended Release Oral CapsuleSCD9cf76f62-48aa-4065-94fd-6fc910391ab55
100660824 HR dexmethylphenidate hydrochloride 40 MG Extended Release Oral CapsuleSCD9cf76f62-48aa-4065-94fd-6fc910391ab55
89951124 HR dexmethylphenidate hydrochloride 5 MG Extended Release Oral CapsuleSCD9cf76f62-48aa-4065-94fd-6fc910391ab55
89944124 HR Focalin 10 MG Extended Release Oral CapsuleSY9cf76f62-48aa-4065-94fd-6fc910391ab55
89946324 HR Focalin 15 MG Extended Release Oral CapsuleSY9cf76f62-48aa-4065-94fd-6fc910391ab55
89948724 HR Focalin 20 MG Extended Release Oral CapsuleSY9cf76f62-48aa-4065-94fd-6fc910391ab55
110192824 HR Focalin 25 MG Extended Release Oral CapsuleSY9cf76f62-48aa-4065-94fd-6fc910391ab55
89949724 HR Focalin 30 MG Extended Release Oral CapsuleSY9cf76f62-48aa-4065-94fd-6fc910391ab55
110193424 HR Focalin 35 MG Extended Release Oral CapsuleSY9cf76f62-48aa-4065-94fd-6fc910391ab55
100661024 HR Focalin 40 MG Extended Release Oral CapsuleSY9cf76f62-48aa-4065-94fd-6fc910391ab55
89951324 HR Focalin 5 MG Extended Release Oral CapsuleSY9cf76f62-48aa-4065-94fd-6fc910391ab55
899439dexmethylphenidate hydrochloride 10 MG 24 HR Extended Release Oral CapsuleSY9cf76f62-48aa-4065-94fd-6fc910391ab55
899461dexmethylphenidate hydrochloride 15 MG 24 HR Extended Release Oral CapsuleSY9cf76f62-48aa-4065-94fd-6fc910391ab55
899485dexmethylphenidate hydrochloride 20 MG 24 HR Extended Release Oral CapsuleSY9cf76f62-48aa-4065-94fd-6fc910391ab55
1101926dexmethylphenidate hydrochloride 25 MG 24 HR Extended Release Oral CapsuleSY9cf76f62-48aa-4065-94fd-6fc910391ab55
899495dexmethylphenidate hydrochloride 30 MG 24 HR Extended Release Oral CapsuleSY9cf76f62-48aa-4065-94fd-6fc910391ab55
1101932dexmethylphenidate hydrochloride 35 MG 24 HR Extended Release Oral CapsuleSY9cf76f62-48aa-4065-94fd-6fc910391ab55
1006608dexmethylphenidate hydrochloride 40 MG 24 HR Extended Release Oral CapsuleSY9cf76f62-48aa-4065-94fd-6fc910391ab55
899511dexmethylphenidate hydrochloride 5 MG 24 HR Extended Release Oral CapsuleSY9cf76f62-48aa-4065-94fd-6fc910391ab55
899441Focalin XR 10 MG 24 HR Extended Release Oral CapsuleSY9cf76f62-48aa-4065-94fd-6fc910391ab55
899463Focalin XR 15 MG 24 HR Extended Release Oral CapsuleSY9cf76f62-48aa-4065-94fd-6fc910391ab55
899487Focalin XR 20 MG 24 HR Extended Release Oral CapsuleSY9cf76f62-48aa-4065-94fd-6fc910391ab55
1101928Focalin XR 25 MG 24 HR Extended Release Oral CapsuleSY9cf76f62-48aa-4065-94fd-6fc910391ab55
899497Focalin XR 30 MG 24 HR Extended Release Oral CapsuleSY9cf76f62-48aa-4065-94fd-6fc910391ab55
1101934Focalin XR 35 MG 24 HR Extended Release Oral CapsuleSY9cf76f62-48aa-4065-94fd-6fc910391ab55
1006610Focalin XR 40 MG 24 HR Extended Release Oral CapsuleSY9cf76f62-48aa-4065-94fd-6fc910391ab55
899513Focalin XR 5 MG 24 HR Extended Release Oral CapsuleSY9cf76f62-48aa-4065-94fd-6fc910391ab55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
66758-241-0166758024101100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66758-241-01) 2025-10-15NoNoHistorical
66758-241-316675802413130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66758-241-31) 2025-11-17NoNoHistorical