NDC 0078-0354

Lescol XL

Fluvastatin Sodium

Lescol XL is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Fluvastatin Sodium.

• Product ID: 0078-0354_04f77269-0504-4ffb-88cf-5834cfc6b173
• NDC: 0078-0354
• Product Type: Human Prescription Drug
• Proprietary Name: Lescol XL
• Generic Name: Fluvastatin Sodium
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2000-10-06
• Marketing Category: NDA / NDA
• Application Number: NDA021192
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: FLUVASTATIN SODIUM
• Active Ingredient Strength: 80 mg/1
• Pharm Classes: HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0078-0354-15

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0078-0354-15)

• Marketing Start Date: 2000-10-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0354-05 [00078035405]

Lescol XL TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA021192
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2000-10-06

NDC 0078-0354-15 [00078035415]

Lescol XL TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA021192
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2000-10-06

Drug Details

Active Ingredients

Ingredient	Strength
FLUVASTATIN SODIUM	80 mg/1

OpenFDA Data

• SPL SET ID: 8a1823e7-26fb-4858-bac7-9e152e5ea16a
• Manufacturer:
  • Novartis Pharmaceuticals Corporation
• UNII:
  • PYF7O1FV7F
• RxNorm Concept Unique ID - RxCUI:
  • 687048
  • 360507
• UPC Code:
  • 0300780354059

Pharmacological Class

• HMG-CoA Reductase Inhibitor [EPC]
• Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

NDC Crossover Matching brand name "Lescol XL" or generic name "Fluvastatin Sodium"

NDC	Brand Name	Generic Name
0093-7446	Fluvastatin Sodium	Fluvastatin Sodium
0527-2580	Fluvastatin Sodium	Fluvastatin Sodium
0781-5370	FLUVASTATIN SODIUM	fluvastatin sodium
0781-8017	FLUVASTATIN SODIUM	fluvastatin sodium
0078-0354	Lescol	fluvastatin sodium
68151-4471	Lescol	fluvastatin sodium