NDC 70655-058

Naloxone HCl

Naloxone Hydrochloride

Naloxone HCl is a Intramuscular; Intravenous; Subcutaneous Injection in the Human Prescription Drug category. It is labeled and distributed by Renaissance Ssa, Llc. The primary component is Naloxone Hydrochloride.

Product ID70655-058_e5d321eb-4c76-488a-9da4-d55587a98380
NDC70655-058
Product TypeHuman Prescription Drug
Proprietary NameNaloxone HCl
Generic NameNaloxone Hydrochloride
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Marketing Start Date2019-12-28
Marketing CategoryANDA / ANDA
Application NumberANDA207846
Labeler NameRenaissance SSA, LLC
Substance NameNALOXONE HYDROCHLORIDE
Active Ingredient Strength0 mg/mL
Pharm ClassesOpioid Antagonist [EPC],Opioid Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70655-058-10

1 VIAL, MULTI-DOSE in 1 CONTAINER (70655-058-10) > 10 mL in 1 VIAL, MULTI-DOSE
Marketing Start Date2019-12-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70655-058-10 [70655005810]

Naloxone HCl INJECTION
Marketing CategoryANDA
Application NumberANDA207846
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-28

Drug Details

Active Ingredients

IngredientStrength
NALOXONE HYDROCHLORIDE.4 mg/mL

OpenFDA Data

SPL SET ID:215933a6-bda3-448e-b749-458d70571ac5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1191222

    • Pharmacological Class

    • Opioid Antagonist [EPC]
    • Opioid Antagonists [MoA]

    NDC Crossover Matching brand name "Naloxone HCl" or generic name "Naloxone Hydrochloride"

    NDCBrand NameGeneric Name
    70655-058Naloxone HClNaloxone HCl
    0093-2165Naloxone HydrochlorideNaloxone Hydrochloride
    0404-9920Naloxone HydrochlorideNaloxone Hydrochloride
    0404-9921NALOXONE HYDROCHLORIDEnaloxone hydrochloride
    0404-9922NALOXONE HYDROCHLORIDEnaloxone hydrochloride
    0404-9923NALOXONE HYDROCHLORIDEnaloxone hydrochloride
    0409-1215Naloxone HydrochlorideNALOXONE HYDROCHLORIDE
    0409-1219Naloxone HydrochlorideNALOXONE HYDROCHLORIDE
    0409-1782Naloxone HydrochlorideNALOXONE HYDROCHLORIDE
    0641-6205Naloxone HydrochlorideNaloxone Hydrochloride
    17478-041Naloxone HydrochlorideNaloxone Hydrochloride
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