NDC 54868-6169

Simcor

Simvastatin And Niacin

Simcor is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Physicians Total Care, Inc.. The primary component is Simvastatin; Niacin.

• Product ID: 54868-6169_85d265f2-9b74-42d3-9b33-c34573be8c1e
• NDC: 54868-6169
• Product Type: Human Prescription Drug
• Proprietary Name: Simcor
• Generic Name: Simvastatin And Niacin
• Dosage Form: Tablet, Film Coated, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2010-09-14
• Marketing Category: NDA / NDA
• Application Number: NDA022078
• Labeler Name: Physicians Total Care, Inc.
• Substance Name: SIMVASTATIN; NIACIN
• Active Ingredient Strength: 40 mg/1; mg/1
• Pharm Classes: HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA],Nicotinic Acid [EPC],Nicotinic Acids [CS]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 54868-6169-0

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (54868-6169-0)

• Marketing Start Date: 2010-09-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 54868-6169-0 [54868616900]

Simcor TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA022078
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-09-14
• Inactivation Date: 2019-09-24

Drug Details

Active Ingredients

Ingredient	Strength
SIMVASTATIN	40 mg/1

OpenFDA Data

• SPL SET ID: dd749fb9-e279-4958-9534-ad75a5b6754b
• Manufacturer:
  • Physicians Total Care, Inc.
• UNII:
  • AGG2FN16EV
  • 2679MF687A
• RxNorm Concept Unique ID - RxCUI:
  • 761909
  • 761907
  • 762970
  • 763232
  • 999939
  • 763236
  • 763228
  • 999935

Pharmacological Class

• HMG-CoA Reductase Inhibitor [EPC]
• Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
• Nicotinic Acid [EPC]
• Nicotinic Acids [CS]