NDC 66869-404

Livalo

Pitavastatin Calcium

Livalo is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Kowa Pharmaceuticals America, Inc.. The primary component is Pitavastatin Calcium.

• Product ID: 66869-404_1783ecd3-0116-4ad8-9a43-25d5b2dc62e6
• NDC: 66869-404
• Product Type: Human Prescription Drug
• Proprietary Name: Livalo
• Generic Name: Pitavastatin Calcium
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-05-16
• Marketing Category: NDA / NDA
• Application Number: NDA022363
• Labeler Name: Kowa Pharmaceuticals America, Inc.
• Substance Name: PITAVASTATIN CALCIUM
• Active Ingredient Strength: 4 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 66869-404-07

7 TABLET, FILM COATED in 1 CARTON (66869-404-07)

• Marketing Start Date: 2019-05-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 66869-404-07 [66869040407]

Livalo TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022363
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-05-16

NDC 66869-404-90 [66869040490]

Livalo TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022363
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-05-16

Drug Details

Active Ingredients

Ingredient	Strength
PITAVASTATIN CALCIUM	4.18 mg/1

OpenFDA Data

• SPL SET ID: 44dcbf97-99ec-427c-ba50-207e0069d6d2
• Manufacturer:
  • Kowa Pharmaceuticals America, Inc.
• UNII:
  • IYD54XEG3W
• RxNorm Concept Unique ID - RxCUI:
  • 861654
  • 861646
  • 861652
  • 861643
  • 861650
  • 861648

Pharmacological Class

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

Medicade Reported Pricing

66869040490 LIVALO 4 MG TABLET

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Livalo" or generic name "Pitavastatin Calcium"

NDC	Brand Name	Generic Name
66869-104	Livalo	pitavastatin calcium
66869-204	Livalo	pitavastatin calcium
66869-404	Livalo	pitavastatin calcium