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 ID68382-427_63951023-2bfe-4973-87f2-07b3f5a010fd
NDC68382-427
Product TypeHuman Prescription Drug
Proprietary NameAmlodipine and atorvastatin
Generic NameAmlodipine And Atorvastatin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-05-30
Marketing CategoryANDA / ANDA
Application NumberANDA207762
Labeler NameZydus Pharmaceuticals (USA) Inc.
Substance NameAMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE
Active Ingredient Strength5 mg/1; mg/1
Pharm ClassesCalcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 68382-427-01

100 TABLET, FILM COATED in 1 BOTTLE (68382-427-01)
Marketing Start Date2019-05-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-427-01 [68382042701]

Amlodipine and atorvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA207762
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-30

NDC 68382-427-06 [68382042706]

Amlodipine and atorvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA207762
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-30

NDC 68382-427-16 [68382042716]

Amlodipine and atorvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA207762
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-30

NDC 68382-427-30 [68382042730]

Amlodipine and atorvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA207762
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-30

NDC 68382-427-77 [68382042777]

Amlodipine and atorvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA207762
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-30

Drug Details

OpenFDA Data

SPL SET ID:594bfb20-fbb0-4c2b-8e89-430e20cb48d4
Manufacturer
UNII

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

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

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