64764-080 : Amitiza 0.008 mg Oral Capsule


NDC: 64764-080
Labeler: Takeda Pharmaceuticals America, Inc.
Product Type: Human Prescription Drug
Drug Name:  Amitiza
Dosage Form: Oral Capsule, Gelatin Coated
Application #: NDA021908
Rev. Date: 


Appearance:


Markings: SPI
Shapes:  Oval
Colors:  Pink
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.

SPI: (64764-080) Amitiza 0.008 mg Oral Capsule by Takeda Pharmaceuticals America, 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:

  • 64764-080-40: 4 CARTON IN 1 CARTON (64764‑080‑40) > 1 BLISTER PACK IN 1 CARTON > 4 CAPSULE, GELATIN COATED IN 1 BLISTER PACK
  • 64764-080-60: 60 CAPSULE, GELATIN COATED IN 1 BOTTLE (64764‑080‑60)

Active Ingredients:

  • Lubiprostone

Dosage Strength:

  • 8 ug/1

Inactive Ingredients:

  • Medium-chain Triglycerides
  • Gelatin
  • Sorbitol
  • Ferric Oxide Red
  • Titanium Dioxide
  • Water

Pharmaceutical Classes:

  • Chloride Channel Activator [EPC]
  • Chloride Channel Activators [MoA]

Related Products:

Based on records with the same trade name.
  • 64764-240 Amitiza 0.024 mg Oral Capsule by Takeda Pharmaceuticals America, Inc.
  • 16590-622 Amitiza 0.008 mg Oral Capsule by Stat Rx USA LLC
  • 23635-508 Amitiza 8 ug/1 Oral Capsule, Gelatin Coated by Specgx LLC
  • 23635-524 Amitiza 24 ug/1 Oral Capsule, Gelatin Coated by Specgx LLC
  • 35356-500 Amitiza 0.024 mg Oral Capsule by Lake Erie Medical Dba Quality Care Products LLC
  • 54868-5971 Amitiza 0.024 mg Oral Capsule by Physicians Total Care, Inc.
  • 54868-6153 Amitiza 0.008 mg Oral Capsule by Physicians Total Care, Inc.
  • 63629-6398 Amitiza 24 ug/1 Oral Capsule, Gelatin Coated by Bryant Ranch Prepack
  • 68151-5003 Amitiza 24 ug/1 Oral Capsule, Gelatin Coated by Carilion Materials Management
  • 69189-0086 Amitiza 8 ug/1 Oral Capsule, Gelatin Coated by Avera Mckennan Hospital

NDC QR Code

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NDC 64764-080 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.