NDC 0378-4515

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 Mylan Pharmaceuticals Inc.. The primary component is Amlodipine Besylate; Atorvastatin Calcium Trihydrate.

Product ID0378-4515_464255cb-bc28-40f6-a5f5-1f781f589bb1
NDC0378-4515
Product TypeHuman Prescription Drug
Proprietary NameAmlodipine and atorvastatin
Generic NameAmlodipine And Atorvastatin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2014-10-16
Marketing CategoryANDA / ANDA
Application NumberANDA200465
Labeler NameMylan Pharmaceuticals 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 Through2023-12-31

Packaging

NDC 0378-4515-93

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4515-93)
Marketing Start Date2014-10-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-4515-20 [00378451520]

Amlodipine and atorvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA200465
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-10-16
Marketing End Date2017-04-06

NDC 0378-4515-93 [00378451593]

Amlodipine and atorvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA200465
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-10-16

NDC 0378-4515-05 [00378451505]

Amlodipine and atorvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA200465
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-10-16
Marketing End Date2017-03-31

NDC 0378-4515-77 [00378451577]

Amlodipine and atorvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA200465
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-10-16
Marketing End Date2017-04-06

Drug Details

Active Ingredients

IngredientStrength
AMLODIPINE BESYLATE5 mg/1

OpenFDA Data

SPL SET ID:4be76756-4114-4d50-a36c-fd410f6c773d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 404011
  • 404013
  • 597990
  • 597971
  • 597967
  • 597977
  • 597974
  • 597980
  • 597993
  • 597984
  • 597987
    • UPC Code
  • 0303784519936
  • 0303784512937
  • 0303784511930
  • 0303784520932
  • 0303784516935
  • 0303784514931
  • 0303784517932
  • 0303784518939
  • 0303784510933
  • 0303784513934
  • 0303784515938

    • Pharmacological Class

    • Calcium Channel Antagonists [MoA]
    • Dihydropyridine Calcium Channel Blocker [EPC]
    • Dihydropyridines [CS]
    • HMG-CoA Reductase Inhibitor [EPC]
    • Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

    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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