NDC 61894-010

Prestalia

Perindopril Arginine, Amlodipine Besylate

Prestalia is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Marina Biotech. The primary component is Perindopril Arginine; Amlodipine Besylate.

• Product ID: 61894-010_0d7199f6-3d4e-4391-85d2-dce6b15d8188
• NDC: 61894-010
• Product Type: Human Prescription Drug
• Proprietary Name: Prestalia
• Generic Name: Perindopril Arginine, Amlodipine Besylate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2015-01-26
• Marketing End Date: 2020-04-30
• Marketing Category: NDA / NDA
• Application Number: NDA205003
• Labeler Name: Marina BioTech
• Substance Name: PERINDOPRIL ARGININE; AMLODIPINE BESYLATE
• Active Ingredient Strength: 4 mg/1; mg/1
• Pharm Classes: Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
• NDC Exclude Flag: N

Packaging

NDC 61894-010-03

7 TABLET in 1 BOTTLE (61894-010-03)

• Marketing Start Date: 2018-06-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61894-010-03 [61894001003]

Prestalia TABLET

• Marketing Category: NDA
• Application Number: NDA205003
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-06-28
• Marketing End Date: 2020-04-30

NDC 61894-010-02 [61894001002]

Prestalia TABLET

• Marketing Category: NDA
• Application Number: NDA205003
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-01-26
• Marketing End Date: 2020-04-30

Drug Details

Active Ingredients

Ingredient	Strength
PERINDOPRIL ARGININE	3.5 mg/1

OpenFDA Data

• SPL SET ID: 98cc3e47-3463-4162-96ac-bf97d77eb041
• Manufacturer:
  • Marina BioTech
• UNII:
  • TFT5IM1KGB
  • 864V2Q084H
• RxNorm Concept Unique ID - RxCUI:
  • 1600716
  • 1600722
  • 1600724
  • 1600726
  • 1600728
  • 1600730

Pharmacological Class

• Angiotensin Converting Enzyme Inhibitor [EPC]
• Angiotensin-converting Enzyme Inhibitors [MoA]
• Calcium Channel Antagonists [MoA]
• Dihydropyridine Calcium Channel Blocker [EPC]
• Dihydropyridines [CS]

NDC Crossover Matching brand name "Prestalia" or generic name "Perindopril Arginine, Amlodipine Besylate"

NDC	Brand Name	Generic Name
61894-010	Prestalia	perindopril arginine, amlodipine besylate
61894-011	Prestalia	perindopril arginine, amlodipine besylate
61894-012	Prestalia	perindopril arginine, amlodipine besylate
72931-010	Prestalia	perindopril arginine and amlodipine besylate
72931-011	Prestalia	perindopril arginine and amlodipine besylate
72931-012	Prestalia	perindopril arginine and amlodipine besylate