59385-041 : Symproic .2 mg Oral Tablet

Labeler: Biodelivery Sciences International Inc
Product Type: Human Prescription Drug
Drug Name:  Symproic
Dosage Form: Oral Tablet
Application #: NDA208854
Rev. Date: 


Markings: 222;0;2
Shapes:  Round
Colors:  Yellow
Size (mm): 7
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:

  • 59385-041-07: 1 BLISTER PACK IN 1 CARTON (59385‑041‑07) > 7 TABLET IN 1 BLISTER PACK
  • 59385-041-30: 30 TABLET IN 1 BOTTLE, PLASTIC (59385‑041‑30)

Active Ingredients:

  • Naldemedine Tosylate

Dosage Strength:

  • .2 mg

Inactive Ingredients:

  • Mannitol
  • Croscarmellose Sodium
  • Magnesium Stearate
  • Hypromellose, Unspecified
  • Talc
  • Ferric Oxide Yellow /

Pharmaceutical Classes:

  • Opioid Antagonist [EPC]
  • Opioid Antagonists [MoA]

Related Products:

Based on records with the same trade name.
  • 59011-523 Symproic .2 mg Oral Tablet by Purdue Pharma Lp
  • 59630-222 Symproic .2 mg Oral Tablet by Shionogi Inc.


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Note: The MedsChat® 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.