0093-2165 NDC - NALOXONE HYDROCHLORIDE

Drug Information

  • Product NDC: 0093-2165
  • Proprietary Name: Naloxone Hydrochloride
  • Non Proprietary Name: Naloxone Hydrochloride
  • Active Ingredient(s): 4 mg/.1mL NALOXONE HYDROCHLORIDE
  • Administration Route(s): NASAL
  • Dosage Form(s): SPRAY, METERED
  • Pharmacy Class(es): Opioid Antagonist [EPC]; Opioid Antagonists [MoA]

Labeler Information

Field Name Field Value
Labeler Name: Teva Pharmaceuticals USA, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA209522
Marketing Category: ANDA
Start Marketing Date:12/22/2021
End Marketing Date:6/30/2026

Package Information

No. Package Code Package Description Billing Unit
10093-2165-682 BLISTER PACK in 1 CARTON (0093-2165-68) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (0093-2165-19) / .1 mL in 1 VIAL, SINGLE-DOSEEA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0093-2165This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGThis corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
PROPRIETARY NAMENaloxone HydrochlorideThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMENaloxone HydrochlorideThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMESPRAY, METEREDThe translation of the dosage form Code submitted by the firm.
ROUTE NAMENASALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE12/22/2021This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE6/30/2026This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
MARKETING CATEGORY NAMEANDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERANDA209522This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMETeva Pharmaceuticals USA, Inc.The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
SUBSTANCE NAMENALOXONE HYDROCHLORIDEThe translation of the dosage form Code submitted by the firm.
ACTIVE NUMERATOR STRENGTH4 
ACTIVE INGRED UNITmg/.1mL 
PHARM CLASSESOpioid Antagonist [EPC], Opioid Antagonists [MoA] 

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This page was last updated on: 12/6/2025

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