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NDC 00591-2971-99 Naloxone Hydrochloride 4 mg/.1mL Details
Naloxone Hydrochloride 4 mg/.1mL
Naloxone Hydrochloride is a NASAL SPRAY, METERED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is NALOXONE HYDROCHLORIDE.
MedlinePlus Drug Summary
Prescription and nonprescription (over the counter) naloxone 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. Naloxone 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: 00591-2971-99Last Updated: 03/24/2024
MedLinePlus Full Drug Details: Naloxone Nasal Spray
Product Information
NDC | 00591-2971 |
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Product ID | 0591-2971_eaa6c32e-87f4-404f-a55e-fccae46392d3 |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | Naloxone Hydrochloride |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Naloxone Hydrochloride |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | SPRAY, METERED |
Route | NASAL |
Active Ingredient Strength | 4 |
Active Ingredient Units | mg/.1mL |
Substance Name | NALOXONE HYDROCHLORIDE |
Labeler Name | Actavis Pharma, Inc. |
Pharmaceutical Class | Opioid Antagonist [EPC], Opioid Antagonists [MoA] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA209522 |
Listing Certified Through | 2024-12-31 |
Package
NDC 00591-2971-99 (00591297199)
NDC Package Code | 0591-2971-99 |
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Billing NDC | 00591297199 |
Package | 2 BLISTER PACK in 1 CARTON (0591-2971-99) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (0591-2971-54) / .1 mL in 1 VIAL, SINGLE-DOSE |
Marketing Start Date | 2023-01-20 |
NDC Exclude Flag | N |
Pricing Information | N/A |