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NDC 67457-0992-02 Naloxone Hydrochloride 1 mg/mL Details
Naloxone Hydrochloride 1 mg/mL
Naloxone Hydrochloride is a INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Institutional LLC. The primary component is NALOXONE HYDROCHLORIDE.
MedlinePlus Drug Summary
Naloxone injection and naloxone prefilled auto-injection device (Evzio) are used along with emergency medical treatment to reverse the life-threatening effects of a known or suspected opiate (narcotic) overdose. Naloxone injection is also used after surgery to reverse the effects of opiates given during surgery. Naloxone injection is given to newborns to decrease the effects of opiates received by the pregnant mother prior to delivery. Naloxone injection 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: 67457-0992-02Last Updated: 02/19/2023
MedLinePlus Full Drug Details: Naloxone Injection
Product Information
| NDC | 67457-0992 |
|---|---|
| Product ID | 67457-992_b41431e9-346e-48ef-a24e-908fb9713885 |
| Associated GPIs | |
| GCN Sequence Number | 004514 |
| GCN Sequence Number Description | naloxone HCl SYRINGE 1 MG/ML INJECTION |
| HIC3 | H3T |
| HIC3 Description | OPIOID ANTAGONISTS |
| GCN | 17142 |
| HICL Sequence Number | 001874 |
| HICL Sequence Number Description | NALOXONE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Naloxone Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Naloxone Hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS |
| Active Ingredient Strength | 1 |
| Active Ingredient Units | mg/mL |
| Substance Name | NALOXONE HYDROCHLORIDE |
| Labeler Name | Mylan Institutional LLC |
| Pharmaceutical Class | Opioid Antagonist [EPC], Opioid Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA213843 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 67457-0992-02 (67457099202)
| NDC Package Code | 67457-992-02 |
|---|---|
| Billing NDC | 67457099202 |
| Package | 1 SYRINGE, GLASS in 1 CARTON (67457-992-02) / 2 mL in 1 SYRINGE, GLASS |
| Marketing Start Date | 2022-12-02 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |