0378-2047 : Tacrolimus 5 mg (As Anhydrous Tacrolimus) Oral Capsule


NDC0378-2047
Labeler: Mylan Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Tacrolimus
Dosage Form: Oral Capsule
Application #: ANDA090596
Rev. Date: 


Appearance:


Markings: MYLAN;2047
Shapes:  Capsule
Colors:  Gray / Red
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.

MYLAN 2047: (0378-2047) Tacrolimus 5 mg (As Anhydrous Tacrolimus) Oral Capsule 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:

  • 0378-2047-01: 100 CAPSULE IN 1 BOTTLE, PLASTIC (0378‑2047‑01)
  • 0378-2047-05: 500 CAPSULE IN 1 BOTTLE, PLASTIC (0378‑2047‑05)

Active Ingredients:

  • Tacrolimus

Dosage Strength:

  • 5 mg

Inactive Ingredients:

  • Anhydrous Lactose
  • Ferrosoferric Oxide
  • Silicon Dioxide
  • Croscarmellose Sodium
  • Gelatin
  • Hypromelloses
  • Lactose Monohydrate
  • Magnesium Stearate
  • Sodium Lauryl Sulfate
  • Titanium Dioxide
  • Ferric Oxide Yellow
  • D&c Red No. 28
  • D&c Yellow No. 10
  • D&c Red No. 33
  • Fd&c Blue No. 1
  • Fd&c Blue No. 2
  • Fd&c Red No. 40
  • Propylene Glycol
  • Shellac

Pharmaceutical Classes:

  • Calcineurin Inhibitor Immunosuppressant [EPC]
  • Calcineurin Inhibitors [MoA]

Related Products:

Based on records with the same trade name.
  • 0378-2045 Tacrolimus 0.5 mg (As Anhydrous Tacrolimus) Oral Capsule by Mylan Pharmaceuticals Inc.
  • 0378-2046 Tacrolimus 1 mg (As Anhydrous Tacrolimus) Oral Capsule by Mylan Pharmaceuticals Inc.
  • 0168-0416 Tacrolimus 1 mg/g Topical Ointment by E. Fougera & Co. a Division of Fougera Pharmaceuticals Inc.
  • 0168-0417 Tacrolimus .3 mg/g Topical Ointment by E. Fougera & Co. a Division of Fougera Pharmaceuticals Inc.
  • 0179-0079 Tacrolimus 1 mg (As Anhydrous Tacrolimus) Oral Capsule by Kaiser Foundation Hospitals
  • 0591-3359 Tacrolimus 5 mg (As Anhydrous Tacrolimus) Oral Capsule by Watson Laboratories, Inc.
  • 0781-2102 Tacrolimus 0.5 mg (As Anhydrous Tacrolimus) Oral Capsule by Sandoz Inc
  • 0781-2103 Tacrolimus 1 mg (As Anhydrous Tacrolimus) Oral Capsule by Sandoz Inc
  • 0781-2104 Tacrolimus 5 mg (As Anhydrous Tacrolimus) Oral Capsule by Sandoz Inc
  • 0781-9302 Tacrolimus 0.5 mg (As Anhydrous Tacrolimus) Oral Capsule by Sandoz Inc
  • 0781-9303 Tacrolimus 1 mg (As Anhydrous Tacrolimus) Oral Capsule by Sandoz Inc
  • 0781-9304 Tacrolimus 5 mg (As Anhydrous Tacrolimus) Oral Capsule by Sandoz Inc
  • 0904-6425 Tacrolimus 1 mg Oral Capsule by Major Pharmaceuticals
  • 0904-6623 Tacrolimus .5 mg Oral Capsule by Major Pharmaceuticals
  • 0904-6624 Tacrolimus 5 mg Oral Capsule by Major Pharmaceuticals
  • 16729-041 Tacrolimus 0.5 mg (As Anhydrous Tacrolimus) Oral Capsule by Accord Heathcare, Inc.
  • 16729-042 Tacrolimus 1 mg (As Anhydrous Tacrolimus) Oral Capsule by Accord Heathcare, Inc.
  • 16729-043 Tacrolimus 5 mg (As Anhydrous Tacrolimus) Oral Capsule by Accord Heathcare, Inc.
  • 16729-421 Tacrolimus .3 mg/g Topical Ointment by Accord Healthcare Inc.
  • 16729-422 Tacrolimus 1 mg/g Topical Ointment by Accord Healthcare Inc.
  • More related products ...

NDC QR Code

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