Dehydrated Alcohol

Product NDC
82983-426
11-digit product format
829830426
Labeler code
82983
Product ID
82983-426_be0bec74-c6a7-49e7-931f-69d289cb366f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alcohol
Dosage form
INJECTION, SOLUTION
Route
PERCUTANEOUS
Labeler
Ajenat Pharmaceuticals LLC
Application
NDA207987
Marketing category
NDA
Marketing start
2025-08-15
Substance
ALCOHOL
Active strength
1 mL/mL
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
ALCOHOL1 mL/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M
Rxcui2048982

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82983-426-01Dehydrated Alcohol5 mL in 1 VIALINJECTION, SOLUTION52
82983-426-10Dehydrated Alcohol10 in 1 CARTONINJECTION, SOLUTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82983-426-01ML - Milliliter82983-426a27d7901-6d5d-43f1-af8b-25f42dd643fe12026-01-08
82983-426-10ML - Milliliter82983-426e2ff2520-030a-4689-895c-7946d98a35d112026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2048982ethanol 99 % in 5 ML InjectionPSN636d6421-cadf-42b3-a431-ba40c06e36d22
20489825 ML ethanol 0.99 ML/ML InjectionSCD636d6421-cadf-42b3-a431-ba40c06e36d22
2048982ethanol 99 % per 5 ML InjectionSY636d6421-cadf-42b3-a431-ba40c06e36d22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82983-426-01829830426015 mL in 1 VIAL5 mlHistorical
82983-426-108298304261010 VIAL in 1 CARTON (82983-426-10) / 5 mL in 1 VIAL (82983-426-01) 10 vial2025-08-15NoNoHistorical