symproic

Generic: naldemedine

Labeler: biodelivery sciences international inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name symproic
Generic Name naldemedine
Labeler biodelivery sciences international inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

naldemedine tosylate .2 mg/1

Manufacturer
BioDelivery Sciences International Inc

Identifiers & Regulatory

Product NDC 59385-041
Product ID 59385-041_7ce44be3-47a7-411e-ad1f-a2efc4916425
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208854
Listing Expiration 2026-12-31
Marketing Start 2019-06-14

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59385041
Hyphenated Format 59385-041

Supplemental Identifiers

RxCUI
1876603 1876609
UPC
0359385041307
UNII
V1N8F1RVVO

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name symproic (source: ndc)
Generic Name naldemedine (source: ndc)
Application Number NDA208854 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .2 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (59385-041-30)
source: ndc

Packages (1)

59385-041-30 30 TABLET in 1 BOTTLE, PLASTIC (59385-041-30)

Ingredients (1)

naldemedine tosylate (.2 mg/1)

Linked Drug Pages (1)

SYMPROIC ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7ce44be3-47a7-411e-ad1f-a2efc4916425", "openfda": {"upc": ["0359385041307"], "unii": ["V1N8F1RVVO"], "rxcui": ["1876603", "1876609"], "spl_set_id": ["b1a1256c-a1eb-4abe-ab1e-30e4711afd16"], "manufacturer_name": ["BioDelivery Sciences International Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (59385-041-30)", "package_ndc": "59385-041-30", "marketing_start_date": "20190614"}], "brand_name": "SYMPROIC", "product_id": "59385-041_7ce44be3-47a7-411e-ad1f-a2efc4916425", "dosage_form": "TABLET", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "59385-041", "generic_name": "naldemedine", "labeler_name": "BioDelivery Sciences International Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SYMPROIC", "active_ingredients": [{"name": "NALDEMEDINE TOSYLATE", "strength": ".2 mg/1"}], "application_number": "NDA208854", "marketing_category": "NDA", "marketing_start_date": "20190614", "listing_expiration_date": "20261231"}