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NDC 12496-0003-02 OPVEE 2.7 mg/100uL Details
OPVEE 2.7 mg/100uL
OPVEE is a NASAL SPRAY in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Indivior Inc.. The primary component is NALMEFENE HYDROCHLORIDE.
MedlinePlus Drug Summary
Nalmefene nasal spray is used along with emergency medical treatment to reverse the life-threatening effects of a known or suspected opiate (narcotic) overdose in adults and children 12 years of age and older. Nalmefene nasal spray is in a class of medications called opiate antagonists. It works by blocking the effects of opiates to relieve dangerous symptoms caused by high levels of opiates in the blood.
Related Packages: 12496-0003-02Last Updated: 03/24/2024
MedLinePlus Full Drug Details: Nalmefene Nasal Spray
Product Information
| NDC | 12496-0003 |
|---|---|
| Product ID | 12496-0003_74d3ee90-30a9-4586-be30-e8093621593e |
| Associated GPIs | |
| GCN Sequence Number | 084821 |
| GCN Sequence Number Description | nalmefene HCl SPRAY 2.7 MG NASAL |
| HIC3 | H3T |
| HIC3 Description | OPIOID ANTAGONISTS |
| GCN | 54207 |
| HICL Sequence Number | 010052 |
| HICL Sequence Number Description | NALMEFENE HCL |
| Brand/Generic | Brand |
| Proprietary Name | OPVEE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | nalmefene hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SPRAY |
| Route | NASAL |
| Active Ingredient Strength | 2.7 |
| Active Ingredient Units | mg/100uL |
| Substance Name | NALMEFENE HYDROCHLORIDE |
| Labeler Name | Indivior Inc. |
| Pharmaceutical Class | Opioid Antagonist [EPC], Opioid Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA217470 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 12496-0003-02 (12496000302)
| NDC Package Code | 12496-0003-2 |
|---|---|
| Billing NDC | 12496000302 |
| Package | 2 BLISTER PACK in 1 CARTON (12496-0003-2) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (12496-0003-1) / 100 uL in 1 VIAL, SINGLE-DOSE |
| Marketing Start Date | 2023-10-02 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |