NDC 72853-051

Naloxone Hydrochloride Auto-Injector

Naloxone Hydrochloride

Naloxone Hydrochloride Auto-Injector is a Intramuscular; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Ij Therapeutics, Llc. The primary component is Naloxone Hydrochloride.

Product ID72853-051_4749ef27-a4f6-4706-85d5-b3df8defc62c
NDC72853-051
Product TypeHuman Prescription Drug
Proprietary NameNaloxone Hydrochloride Auto-Injector
Generic NameNaloxone Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; SUBCUTANEOUS
Marketing Start Date2019-12-31
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA209862
Labeler NameIJ Therapeutics, LLC
Substance NameNALOXONE HYDROCHLORIDE
Active Ingredient Strength2 mg/.4mL
Pharm ClassesOpioid Antagonist [EPC],Opioid Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 72853-051-02

2 DOSE PACK in 1 CARTON (72853-051-02) > .4 mL in 1 DOSE PACK
Marketing Start Date2019-12-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72853-051-02 [72853005102]

Naloxone Hydrochloride Auto-Injector INJECTION, SOLUTION
Marketing CategoryNDA authorized generic
Application NumberNDA209862
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-12-31

Drug Details

Active Ingredients

IngredientStrength
NALOXONE HYDROCHLORIDE2 mg/.4mL

Pharmacological Class

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

NDC Crossover Matching brand name "Naloxone Hydrochloride Auto-Injector" or generic name "Naloxone Hydrochloride"

NDCBrand NameGeneric Name
72853-051Naloxone Hydrochloride Auto-InjectorNaloxone Hydrochloride Auto-Injector
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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