NDC 68382-427

Amlodipine and atorvastatin

Amlodipine And Atorvastatin

Amlodipine and atorvastatin is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Amlodipine Besylate; Atorvastatin Calcium Trihydrate.

• Product ID: 68382-427_63951023-2bfe-4973-87f2-07b3f5a010fd
• NDC: 68382-427
• Product Type: Human Prescription Drug
• Proprietary Name: Amlodipine and atorvastatin
• Generic Name: Amlodipine And Atorvastatin
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-05-30
• Marketing Category: ANDA / ANDA
• Application Number: ANDA207762
• Labeler Name: Zydus Pharmaceuticals (USA) Inc.
• Substance Name: AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE
• Active Ingredient Strength: 5 mg/1; mg/1
• Pharm Classes: Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 68382-427-01

100 TABLET, FILM COATED in 1 BOTTLE (68382-427-01)

• Marketing Start Date: 2019-05-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68382-427-01 [68382042701]

Amlodipine and atorvastatin TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA207762
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-05-30

NDC 68382-427-06 [68382042706]

Amlodipine and atorvastatin TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA207762
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-05-30

NDC 68382-427-16 [68382042716]

Amlodipine and atorvastatin TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA207762
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-05-30

NDC 68382-427-30 [68382042730]

Amlodipine and atorvastatin TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA207762
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-05-30

NDC 68382-427-77 [68382042777]

Amlodipine and atorvastatin TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA207762
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-05-30

Drug Details

OpenFDA Data

• SPL SET ID: 594bfb20-fbb0-4c2b-8e89-430e20cb48d4
• Manufacturer:
  • Zydus Pharmaceuticals (USA) Inc.
• UNII:
  • 864V2Q084H
  • 48A5M73Z4Q

NDC Crossover Matching brand name "Amlodipine and atorvastatin" or generic name "Amlodipine And Atorvastatin"

NDC	Brand Name	Generic Name
0378-4510	Amlodipine and atorvastatin	Amlodipine and atorvastatin
0378-4511	Amlodipine and atorvastatin	Amlodipine and atorvastatin
0378-4512	Amlodipine and atorvastatin	Amlodipine and atorvastatin
0378-4513	Amlodipine and atorvastatin	Amlodipine and atorvastatin
0378-4514	Amlodipine and atorvastatin	Amlodipine and atorvastatin
0378-4515	Amlodipine and atorvastatin	Amlodipine and atorvastatin
0378-4516	Amlodipine and atorvastatin	Amlodipine and atorvastatin
0378-4517	Amlodipine and atorvastatin	Amlodipine and atorvastatin
0378-4518	Amlodipine and atorvastatin	Amlodipine and atorvastatin
0378-4519	Amlodipine and atorvastatin	Amlodipine and atorvastatin
0378-4520	Amlodipine and atorvastatin	Amlodipine and atorvastatin
70771-1463	Amlodipine and atorvastatin	Amlodipine and atorvastatin
70771-1458	Amlodipine and atorvastatin	Amlodipine and atorvastatin
70771-1459	Amlodipine and atorvastatin	Amlodipine and atorvastatin
70771-1461	Amlodipine and atorvastatin	Amlodipine and atorvastatin
70771-1465	Amlodipine and atorvastatin	Amlodipine and atorvastatin
70771-1460	Amlodipine and atorvastatin	Amlodipine and atorvastatin
70771-1466	Amlodipine and atorvastatin	Amlodipine and atorvastatin
70771-1464	Amlodipine and atorvastatin	Amlodipine and atorvastatin
70771-1457	Amlodipine and atorvastatin	Amlodipine and atorvastatin
70771-1467	Amlodipine and atorvastatin	Amlodipine and atorvastatin
70771-1462	Amlodipine and atorvastatin	Amlodipine and atorvastatin
68382-427	Amlodipine and atorvastatin	Amlodipine and atorvastatin
68382-425	Amlodipine and atorvastatin	Amlodipine and atorvastatin
68382-432	Amlodipine and atorvastatin	Amlodipine and atorvastatin
68382-428	Amlodipine and atorvastatin	Amlodipine and atorvastatin
68382-429	Amlodipine and atorvastatin	Amlodipine and atorvastatin
68382-424	Amlodipine and atorvastatin	Amlodipine and atorvastatin
68382-431	Amlodipine and atorvastatin	Amlodipine and atorvastatin
68382-426	Amlodipine and atorvastatin	Amlodipine and atorvastatin
68382-430	Amlodipine and atorvastatin	Amlodipine and atorvastatin
68382-434	Amlodipine and atorvastatin	Amlodipine and atorvastatin
68382-433	Amlodipine and atorvastatin	Amlodipine and atorvastatin
0069-6180	Caduet	amlodipine and atorvastatin
0069-6323	Caduet	amlodipine and atorvastatin
0069-6565	Caduet	amlodipine and atorvastatin
0069-6747	Caduet	amlodipine and atorvastatin
0069-7232	Caduet	amlodipine and atorvastatin
0069-7476	Caduet	amlodipine and atorvastatin
0069-7654	Caduet	amlodipine and atorvastatin
0069-7810	Caduet	amlodipine and atorvastatin