NDC 69101-505

Consensi

Amlodipine Besylate And Celecoxib

Consensi is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Burke Therapeutics, Llc. The primary component is Amlodipine Besylate; Celecoxib.

• Product ID: 69101-505_99e8566d-75ed-391f-e053-2995a90af8f2
• NDC: 69101-505
• Product Type: Human Prescription Drug
• Proprietary Name: Consensi
• Generic Name: Amlodipine Besylate And Celecoxib
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2019-12-17
• Marketing Category: NDA / NDA
• Application Number: NDA210045
• Labeler Name: Burke Therapeutics, LLC
• Substance Name: AMLODIPINE BESYLATE; CELECOXIB
• Active Ingredient Strength: 5 mg/1; mg/1
• Pharm Classes: Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 69101-505-30

30 TABLET in 1 BOTTLE (69101-505-30)

• Marketing Start Date: 2019-12-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69101-505-30 [69101050530]

Consensi TABLET

• Marketing Category: NDA
• Application Number: NDA210045
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-12-17

NDC 69101-505-50 [69101050550]

Consensi TABLET

• Marketing Category: NDA
• Application Number: NDA210045
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-12-17

Drug Details

Active Ingredients

Ingredient	Strength
AMLODIPINE BESYLATE	5 mg/1

Pharmacological Class

• Calcium Channel Antagonists [MoA]
• Dihydropyridine Calcium Channel Blocker [EPC]
• Dihydropyridines [CS]
• Cyclooxygenase Inhibitors [MoA]
• Anti-Inflammatory Agents
• Non-Steroidal [CS]
• Nonsteroidal Anti-inflammatory Drug [EPC]
• Calcium Channel Antagonists [MoA]
• Dihydropyridine Calcium Channel Blocker [EPC]
• Dihydropyridines [CS]
• Cyclooxygenase Inhibitors [MoA]
• Anti-Inflammatory Agents
• Non-Steroidal [CS]
• Nonsteroidal Anti-inflammatory Drug [EPC]

NDC Crossover Matching brand name "Consensi" or generic name "Amlodipine Besylate And Celecoxib"

NDC	Brand Name	Generic Name
69101-502	Consensi	amlodipine besylate and celecoxib
69101-505	Consensi	amlodipine besylate and celecoxib
69101-510	Consensi	amlodipine besylate and celecoxib