FDA.reportPublic FDA data

nalmefene hydrochloride

Product NDC
82432-101
11-digit product format
824320101
Labeler code
82432
Product ID
82432-101_52b8bd13-33cb-4def-a172-8853a39fe4c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nalmefene hydrochloride injection
Dosage form
SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Chengdu Shuode Pharmaceutical Co., Ltd
Application
ANDA216007
Marketing category
ANDA
Marketing start
2023-11-15
Substance
NALMEFENE HYDROCHLORIDE
Active strength
.1 mg/mL
Pharmacologic classes
Opioid Antagonist [EPC], Opioid Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
nalmefene hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NALMEFENE HYDROCHLORIDE.1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK7K69QC05X
Rxcui2592953, 2672926

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e7798c38-a53e-489a-b98c-9f4b01c0aab9Product name220250731
437f042c-2a66-4faa-b06c-0be5226687faProduct name120250313
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
c8c002c1-b6e1-4b46-8d55-5530f0dfb1b4Product name120231013
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82432-101-01nalmefene hydrochloride1 mL in 1 VIAL, GLASSSOLUTION15
82432-101-01nalmefene hydrochloride1 in 1 CARTONSOLUTION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82432-101NALMEFENE HYDROCHLORIDE (NALMEFENE HYDROCHLORIDE INJECTION) SOLUTION [CHENGDU SHUODE PHARMACEUTICAL CO., LTD]5Current NDC, 2 package rows20240110_22d67228-6c24-47ca-afc7-52ef279520a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2672926nalmefene 100 MCG in 1 ML InjectionPSN22d67228-6c24-47ca-afc7-52ef279520a05
2592953nalmefene hydrochloride 2 MG in 2 ML InjectionPSN22d67228-6c24-47ca-afc7-52ef279520a05
26729261 ML nalmefene 0.1 MG/ML InjectionSCD22d67228-6c24-47ca-afc7-52ef279520a05
25929532 ML nalmefene 1 MG/ML InjectionSCD22d67228-6c24-47ca-afc7-52ef279520a05
2672926nalmefene (as nalmefene hydrochloride) 100 MCG per 1 ML InjectionSY22d67228-6c24-47ca-afc7-52ef279520a05
2592953nalmefene (as nalmefene hydrochloride) 2 MG per 2 ML InjectionSY22d67228-6c24-47ca-afc7-52ef279520a05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82432-101-01824320101011 VIAL, GLASS in 1 CARTON (82432-101-01) / 1 mL in 1 VIAL, GLASS2023-11-15NoNoCurrent