0378-6168 : Amlodipine (As Amlodipine Besylate) 10 mg / Atorvastatin (As Atorvastatin Calcium) 10 mg Oral Tablet


NDC: 0378-6168
Labeler: Mylan Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Amlodipine Besylate/Atorvastatin Calcium
Dosage Form: Oral Tablet, Film Coated
Application #: NDA021540
Rev. Date: 


Appearance:


Markings: AAT;101;MYLAN
Shapes:  Oval
Colors:  Blue
Size (mm): 9
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.

AAT 101 MYLAN: (0378-6168) Amlodipine (As Amlodipine Besylate) 10 mg / Atorvastatin (As Atorvastatin Calcium) 10 mg Oral Tablet by Mylan Pharmaceuticals Inc.
The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

  • 0378-6168-05: 500 TABLET, FILM COATED IN 1 BOTTLE (0378‑6168‑05)
  • 0378-6168-77: 90 TABLET, FILM COATED IN 1 BOTTLE (0378‑6168‑77)
  • 0378-6168-93: 30 TABLET, FILM COATED IN 1 BOTTLE (0378‑6168‑93)

Active Ingredients:

  • Amlodipine Besylate
  • Atorvastatin Calcium Trihydrate

Dosage Strength:

  • 10 mg
  • 10 mg

Inactive Ingredients:

  • Calcium Carbonate
  • Croscarmellose Sodium
  • Cellulose, Microcrystalline
  • Polysorbate 80
  • Hydroxypropyl Cellulose (Type H)
  • Water
  • Silicon Dioxide
  • Magnesium Stearate
  • Polyvinyl Alcohol
  • Titanium Dioxide
  • Polyethylene Glycol 3000
  • Talc
  • Fd&c Blue No. 2

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.
  • 0378-6161 Amlodipine (As Amlodipine Besylate) 2.5 mg / Atorvastatin (As Atorvastatin Calcium) 10 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-6162 Amlodipine (As Amlodipine Besylate) 2.5 mg / Atorvastatin (As Atorvastatin Calcium) 20 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-6163 Amlodipine (As Amlodipine Besylate) 2.5 mg / Atorvastatin (As Atorvastatin Calcium) 40 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-6164 Amlodipine (As Amlodipine Besylate) 5 mg / Atorvastatin (As Atorvastatin Calcium) 10 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-6165 Amlodipine (As Amlodipine Besylate) 5 mg / Atorvastatin (As Atorvastatin Calcium) 20 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-6166 Amlodipine (As Amlodipine Besylate) 5 mg / Atorvastatin (As Atorvastatin Calcium) 40 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-6167 Amlodipine (As Amlodipine Besylate) 5 mg / Atorvastatin (As Atorvastatin Calcium) 80 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-6169 Amlodipine (As Amlodipine Besylate) 10 mg / Atorvastatin (As Atorvastatin Calcium) 20 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-6170 Amlodipine (As Amlodipine Besylate) 10 mg / Atorvastatin (As Atorvastatin Calcium) 40 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-6171 Amlodipine (As Amlodipine Besylate) 10 mg / Atorvastatin (As Atorvastatin Calcium) 80 mg Oral Tablet by Mylan Pharmaceuticals Inc.

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.