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NDC 59385-0041-30 SYMPROIC 0.2 mg/1 Details
SYMPROIC 0.2 mg/1
SYMPROIC is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by BioDelivery Sciences International Inc. The primary component is NALDEMEDINE TOSYLATE.
MedlinePlus Drug Summary
Naldemedine is used to treat constipation caused by opioid (narcotic) pain medications in adults with chronic (ongoing) pain that is not caused by cancer. Naldemedine is in a class of medications called peripherally acting mu-opioid receptor antagonists. It works by protecting the bowel from the effects of opioid (narcotic) medications.
Related Packages: 59385-0041-30Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Naldemedine
Product Information
| NDC | 59385-0041 |
|---|---|
| Product ID | 59385-041_e28338cb-0ff5-4938-a82f-0d855ad3b587 |
| Associated GPIs | 52580057200320 |
| GCN Sequence Number | 077258 |
| GCN Sequence Number Description | naldemedine tosylate TABLET 0.2 MG ORAL |
| HIC3 | H3Y |
| HIC3 Description | MU-OPIOID RECEPTOR ANTAGONISTS,PERIPHERALLY-ACTING |
| GCN | 43216 |
| HICL Sequence Number | 044176 |
| HICL Sequence Number Description | NALDEMEDINE TOSYLATE |
| Brand/Generic | Brand |
| Proprietary Name | SYMPROIC |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | naldemedine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 0.2 |
| Active Ingredient Units | mg/1 |
| Substance Name | NALDEMEDINE TOSYLATE |
| Labeler Name | BioDelivery Sciences International Inc |
| Pharmaceutical Class | Opioid Antagonist [EPC], Opioid Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA208854 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 59385-0041-30 (59385004130)
| NDC Package Code | 59385-041-30 |
|---|---|
| Billing NDC | 59385004130 |
| Package | 30 TABLET in 1 BOTTLE, PLASTIC (59385-041-30) |
| Marketing Start Date | 2019-06-14 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 14.773 |
| Pricing Unit | EA |
| Effective Date | 2024-01-01 |
| NDC Description | SYMPROIC 0.2 MG TABLET |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 4 |
| Classification for Rate Setting | B |
| As of Date | 2024-02-21 |
This pricing file, entitled the NADAC (National Average Drug Acquisition
Cost) files, provide
state Medicaid agencies with covered outpatient drug prices by averaging
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