Dehydrated Alcohol

Product NDC
50742-539
11-digit product format
507420539
Labeler code
50742
Product ID
50742-539_149c50c5-59ad-4602-ad9e-58ad960eb91d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dehydrated alcohol
Dosage form
INJECTION, SOLUTION
Route
PERCUTANEOUS
Labeler
Ingenus Pharmaceuticals, LLC
Application
ANDA219569
Marketing category
ANDA
Marketing start
2025-07-09
Substance
DEHYDRATED ALCOHOL
Active strength
5 mL/5mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dehydrated Alcohol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEHYDRATED ALCOHOL5 mL/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M
Rxcui2048982

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50742-539-01Dehydrated Alcohol5 mL in 1 VIAL, GLASSINJECTION, SOLUTION53
50742-539-10Dehydrated Alcohol10 in 1 CARTONINJECTION, SOLUTION103

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2048982ethanol 99 % in 5 ML InjectionPSN1d5ec6f9-d58f-4651-a4a1-93fec13fd4383
20489825 ML ethanol 0.99 ML/ML InjectionSCD1d5ec6f9-d58f-4651-a4a1-93fec13fd4383
2048982ethanol 99 % per 5 ML InjectionSY1d5ec6f9-d58f-4651-a4a1-93fec13fd4383

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50742-539-01507420539015 mL in 1 VIAL, GLASS5 mlHistorical
50742-539-105074205391010 VIAL, GLASS in 1 CARTON (50742-539-10) / 5 mL in 1 VIAL, GLASS (50742-539-01) 2025-07-09NoNoHistorical