NDC 72931-010

Prestalia

Perindopril Arginine And Amlodipine Besylate

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

• Product ID: 72931-010_cc9b436d-0d79-47c6-b001-878fcb233384
• NDC: 72931-010
• Product Type: Human Prescription Drug
• Proprietary Name: Prestalia
• Generic Name: Perindopril Arginine And Amlodipine Besylate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2015-01-26
• Marketing Category: NDA / NDA
• Application Number: NDA205003
• Labeler Name: Adhera Therapeutics, Inc.
• 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
• Listing Certified Through: 2020-12-31

Packaging

NDC 72931-010-02

90 TABLET in 1 BOTTLE, PLASTIC (72931-010-02)

• Marketing Start Date: 2015-01-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 72931-010-03 [72931001003]

Prestalia TABLET

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

NDC 72931-010-02 [72931001002]

Prestalia TABLET

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

Drug Details

Active Ingredients

Ingredient	Strength
PERINDOPRIL ARGININE	3.5 mg/1

Pharmacological Class

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