0378-4515 : Amlodipine and Atorvastatin Oral Tablet, Film Coated


NDC: 0378-4515
Labeler: Mylan Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name: Amlodipine and Atorvastatin
Dosage Form: Oral Tablet, Film Coated
Application #: ANDA200465
Rev. Date: 


Appearance:


Markings: M;AA6
Shapes:  Oval
Colors:  White
Size (mm): 14
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

  • 0378-4515-05: 500 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (0378‑4515‑05)
  • 0378-4515-20: 200 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (0378‑4515‑20)
  • 0378-4515-77: 90 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (0378‑4515‑77)
  • 0378-4515-93: 30 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (0378‑4515‑93)

Active Ingredients:

  • Amlodipine Besylate
  • Atorvastatin Calcium Trihydrate

Dosage Strength:

  • 5 mg
  • 40 mg

Inactive Ingredients:

  • Sodium Carbonate
  • Silicon Dioxide
  • Croscarmellose Sodium
  • Hydroxypropyl Cellulose (Type H)
  • Arginine
  • Lecithin, Soybean
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Polyvinyl Alcohol
  • Starch, Corn
  • Talc
  • Titanium Dioxide
  • Xanthan Gum

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 0378-4510 Amlodipine and Atorvastatin Oral Tablet, Film Coated by Mylan Pharmaceuticals Inc.
  • 0378-4511 Amlodipine and Atorvastatin Oral Tablet, Film Coated by Mylan Pharmaceuticals Inc.
  • 0378-4512 Amlodipine and Atorvastatin Oral Tablet, Film Coated by Mylan Pharmaceuticals Inc.
  • 0378-4513 Amlodipine and Atorvastatin Oral Tablet, Film Coated by Mylan Pharmaceuticals Inc.
  • 0378-4514 Amlodipine and Atorvastatin Oral Tablet, Film Coated by Mylan Pharmaceuticals Inc.
  • 0378-4516 Amlodipine and Atorvastatin Oral Tablet, Film Coated by Mylan Pharmaceuticals Inc.
  • 0378-4517 Amlodipine and Atorvastatin Oral Tablet, Film Coated by Mylan Pharmaceuticals Inc.
  • 0378-4518 Amlodipine and Atorvastatin Oral Tablet, Film Coated by Mylan Pharmaceuticals Inc.
  • 0378-4519 Amlodipine and Atorvastatin Oral Tablet, Film Coated by Mylan Pharmaceuticals Inc.
  • 0378-4520 Amlodipine and Atorvastatin Oral Tablet, Film Coated by Mylan Pharmaceuticals Inc.
  • 60505-3478 Amlodipine and Atorvastatin Oral Tablet, Film Coated by Apotex Corp.
  • 60505-3479 Amlodipine and Atorvastatin Oral Tablet, Film Coated by Apotex Corp.
  • 60505-3483 Amlodipine and Atorvastatin Oral Tablet, Film Coated by Apotex Corp.
  • 60505-3484 Amlodipine and Atorvastatin Oral Tablet, Film Coated by Apotex Corp.
  • 60505-3488 Amlodipine and Atorvastatin Oral Tablet, Film Coated by Apotex Corp.
  • 60505-3489 Amlodipine and Atorvastatin Oral Tablet, Film Coated by Apotex Corp.
  • 60505-3492 Amlodipine and Atorvastatin Oral Tablet, Film Coated by Apotex Corp.
  • 60505-3493 Amlodipine and Atorvastatin Oral Tablet, Film Coated by Apotex Corp.
  • 66993-263 Amlodipine and Atorvastatin Oral Tablet, Coated by Prasco Laboratories
  • 66993-264 Amlodipine and Atorvastatin Oral Tablet, Coated by Prasco Laboratories
  • More related products ...

NDC QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.