NDC 0078-0493

Focalin XR

Dexmethylphenidate Hydrochloride

Focalin XR is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Dexmethylphenidate Hydrochloride.

• Product ID: 0078-0493_1994ede6-bb5d-43ea-9d09-ed27a81578dd
• NDC: 0078-0493
• Product Type: Human Prescription Drug
• Proprietary Name: Focalin XR
• Generic Name: Dexmethylphenidate Hydrochloride
• Dosage Form: Capsule, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2005-05-31
• Marketing Category: NDA / NDA
• Application Number: NDA021802
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: DEXMETHYLPHENIDATE HYDROCHLORIDE
• Active Ingredient Strength: 15 mg/1
• Pharm Classes: Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
• DEA Schedule: CII
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0078-0493-05

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0493-05)

• Marketing Start Date: 2005-05-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0493-05 [00078049305]

Focalin XR CAPSULE, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA021802
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2005-05-31

Drug Details

Active Ingredients

Ingredient	Strength
DEXMETHYLPHENIDATE HYDROCHLORIDE	15 mg/1

OpenFDA Data

• SPL SET ID: 1a1da905-42a0-4748-9c39-67eca45deccc
• Manufacturer:
  • Novartis Pharmaceuticals Corporation
• UNII:
  • 1678OK0E08
• RxNorm Concept Unique ID - RxCUI:
  • 899485
  • 899487
  • 899497
  • 899513
  • 899495
  • 899511
  • 899441
  • 1101934
  • 1101926
  • 1101932
  • 899463
  • 899461
  • 1006610
  • 1101928
  • 899439
  • 1006608

Pharmacological Class

• Central Nervous System Stimulant [EPC]
• Central Nervous System Stimulation [PE]

NDC Crossover Matching brand name "Focalin XR" or generic name "Dexmethylphenidate Hydrochloride"

NDC	Brand Name	Generic Name
0078-0493	Focalin XR	Focalin XR
0078-0608	Focalin XR	Focalin XR
0078-0609	Focalin XR	Focalin XR
0078-0380	Focalin	dexmethylphenidate hydrochloride
0078-0381	Focalin	dexmethylphenidate hydrochloride
0078-0382	Focalin	dexmethylphenidate hydrochloride
0078-0430	Focalin	dexmethylphenidate hydrochloride
0078-0431	Focalin	dexmethylphenidate hydrochloride
0078-0432	Focalin	dexmethylphenidate hydrochloride
0078-0433	Focalin	dexmethylphenidate hydrochloride
0078-0434	Focalin	dexmethylphenidate hydrochloride