nalmefene hydrochloride

Generic: nalmefene hydrochloride injection

Labeler: chengdu shuode pharmaceutical co., ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nalmefene hydrochloride
Generic Name nalmefene hydrochloride injection
Labeler chengdu shuode pharmaceutical co., ltd
Dosage Form SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

nalmefene hydrochloride .1 mg/mL

Manufacturer
Chengdu Shuode Pharmaceutical Co., Ltd

Identifiers & Regulatory

Product NDC 82432-101
Product ID 82432-101_52b8bd13-33cb-4def-a172-8853a39fe4c4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216007
Listing Expiration 2026-12-31
Marketing Start 2023-11-15

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82432101
Hyphenated Format 82432-101

Supplemental Identifiers

RxCUI
2592953 2672926
UPC
6950425900789
UNII
K7K69QC05X

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 nalmefene hydrochloride (source: ndc)
Generic Name nalmefene hydrochloride injection (source: ndc)
Application Number ANDA216007 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • .1 mg/mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (82432-101-01) / 1 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

82432-101-01 1 VIAL, GLASS in 1 CARTON (82432-101-01) / 1 mL in 1 VIAL, GLASS

Ingredients (1)

nalmefene hydrochloride (.1 mg/mL)

Linked Drug Pages (1)

nalmefene hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "52b8bd13-33cb-4def-a172-8853a39fe4c4", "openfda": {"upc": ["6950425900789"], "unii": ["K7K69QC05X"], "rxcui": ["2592953", "2672926"], "spl_set_id": ["22d67228-6c24-47ca-afc7-52ef279520a0"], "manufacturer_name": ["Chengdu Shuode Pharmaceutical Co., Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (82432-101-01)  / 1 mL in 1 VIAL, GLASS", "package_ndc": "82432-101-01", "marketing_start_date": "20231115"}], "brand_name": "nalmefene hydrochloride", "product_id": "82432-101_52b8bd13-33cb-4def-a172-8853a39fe4c4", "dosage_form": "SOLUTION", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "82432-101", "generic_name": "nalmefene hydrochloride injection", "labeler_name": "Chengdu Shuode Pharmaceutical Co., Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "nalmefene hydrochloride", "active_ingredients": [{"name": "NALMEFENE HYDROCHLORIDE", "strength": ".1 mg/mL"}], "application_number": "ANDA216007", "marketing_category": "ANDA", "marketing_start_date": "20231115", "listing_expiration_date": "20261231"}