naloxone hydrochloride

Generic: naloxone hydrochloride

Labeler: baxter healthcare corporation
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naloxone hydrochloride
Generic Name naloxone hydrochloride
Labeler baxter healthcare corporation
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

naloxone hydrochloride .4 mg/mL

Manufacturer
Baxter Healthcare Corporation

Identifiers & Regulatory

Product NDC 36000-308
Product ID 36000-308_ad8223dd-206d-4fd8-b0fb-de10e970a9e1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214785
Listing Expiration 2027-12-31
Marketing Start 2021-01-29

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36000308
Hyphenated Format 36000-308

Supplemental Identifiers

RxCUI
1659929
UPC
0336000308014
UNII
F850569PQR

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name naloxone hydrochloride (source: ndc)
Generic Name naloxone hydrochloride (source: ndc)
Application Number ANDA214785 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • .4 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (36000-308-10) / 1 mL in 1 VIAL, SINGLE-DOSE (36000-308-01)
source: ndc

Packages (1)

36000-308-10 10 VIAL, SINGLE-DOSE in 1 CARTON (36000-308-10) / 1 mL in 1 VIAL, SINGLE-DOSE (36000-308-01)

Ingredients (1)

naloxone hydrochloride (.4 mg/mL)

Linked Drug Pages (1)

naloxone hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "ad8223dd-206d-4fd8-b0fb-de10e970a9e1", "openfda": {"upc": ["0336000308014"], "unii": ["F850569PQR"], "rxcui": ["1659929"], "spl_set_id": ["d04ae2d7-01b9-405d-bb7a-bf2d876ce26a"], "manufacturer_name": ["Baxter Healthcare Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (36000-308-10)  / 1 mL in 1 VIAL, SINGLE-DOSE (36000-308-01)", "package_ndc": "36000-308-10", "marketing_start_date": "20210129"}], "brand_name": "naloxone hydrochloride", "product_id": "36000-308_ad8223dd-206d-4fd8-b0fb-de10e970a9e1", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "36000-308", "generic_name": "naloxone hydrochloride", "labeler_name": "Baxter Healthcare Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "naloxone hydrochloride", "active_ingredients": [{"name": "NALOXONE HYDROCHLORIDE", "strength": ".4 mg/mL"}], "application_number": "ANDA214785", "marketing_category": "ANDA", "marketing_start_date": "20210129", "listing_expiration_date": "20271231"}