NDC 0093-7446

Fluvastatin Sodium

Fluvastatin Sodium

Fluvastatin Sodium is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Teva Pharmaceuticals Usa, Inc.. The primary component is Fluvastatin Sodium.

• Product ID: 0093-7446_03b735d3-1bc2-4163-8b8b-e29a41cf4f07
• NDC: 0093-7446
• Product Type: Human Prescription Drug
• Proprietary Name: Fluvastatin Sodium
• Generic Name: Fluvastatin Sodium
• Dosage Form: Tablet, Film Coated, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2016-06-02
• Marketing Category: ANDA / ANDA
• Application Number: ANDA079011
• Labeler Name: Teva Pharmaceuticals USA, Inc.
• 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: 2022-12-31

Packaging

NDC 0093-7446-01

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-7446-01)

• Marketing Start Date: 2016-06-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0093-7446-56 [00093744656]

Fluvastatin Sodium TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA079011
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-06-02

NDC 0093-7446-01 [00093744601]

Fluvastatin Sodium TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA079011
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-06-02

Drug Details

Active Ingredients

Ingredient	Strength
FLUVASTATIN SODIUM	80 mg/1

OpenFDA Data

• SPL SET ID: cc55110f-1ad6-4f97-840d-62b3a5ac415a
• Manufacturer:
  • Teva Pharmaceuticals USA, Inc.
• UNII:
  • PYF7O1FV7F
• RxNorm Concept Unique ID - RxCUI:
  • 360507

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0093-7446	Fluvastatin Sodium	Fluvastatin Sodium
0378-5121	Fluvastatin Sodium	fluvastatin
0378-8020	Fluvastatin Sodium	fluvastatin
0378-8021	Fluvastatin Sodium	fluvastatin
0527-2580	Fluvastatin Sodium	Fluvastatin Sodium
0781-5370	FLUVASTATIN SODIUM	fluvastatin sodium
0781-8017	FLUVASTATIN SODIUM	fluvastatin sodium
68151-1326	Fluvastatin Sodium	fluvastatin
68151-1334	Fluvastatin Sodium	fluvastatin
0078-0354	Lescol	fluvastatin sodium
68151-4471	Lescol	fluvastatin sodium