Dehydrated Alcohol

Product NDC
54288-144
11-digit product format
542880144
Labeler code
54288
Product ID
54288-144_3f7c9eef-80cc-48f3-a96f-faa55e77ef87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alcohol
Dosage form
INJECTION, SOLUTION
Route
PERCUTANEOUS
Labeler
BPI Labs, LLC
Application
NDA207987
Marketing category
NDA
Marketing start
2025-04-01
Substance
ALCOHOL
Active strength
1 mL/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dehydrated Alcohol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL1 mL/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M
Rxcui2048979, 2048982

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54288-144-01Dehydrated Alcohol5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION512
54288-144-10Dehydrated Alcohol10 in 1 CARTONINJECTION, SOLUTION1012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54288-144-01ML - Milliliter54288-1443cd4cdc0-08b8-4626-83c8-6d21d3167de712025-06-13
54288-144-10ML - Milliliter54288-144893d1374-0435-4d57-8479-d50d083e2c9012025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54288-144DEHYDRATED ALCOHOL (ALCOHOL) INJECTION, SOLUTION [BPI LABS, LLC]10Current NDC, 2 package rows20250402_314b1dab-8f4f-49ae-a105-f974842818b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2048979ethanol 99 % in 1 ML InjectionPSN314b1dab-8f4f-49ae-a105-f974842818b812
2048982ethanol 99 % in 5 ML InjectionPSN314b1dab-8f4f-49ae-a105-f974842818b812
20489791 ML ethanol 0.99 ML/ML InjectionSCD314b1dab-8f4f-49ae-a105-f974842818b812
20489825 ML ethanol 0.99 ML/ML InjectionSCD314b1dab-8f4f-49ae-a105-f974842818b812
2048979ethanol 99 % per 1 ML InjectionSY314b1dab-8f4f-49ae-a105-f974842818b812
2048982ethanol 99 % per 5 ML InjectionSY314b1dab-8f4f-49ae-a105-f974842818b812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
54288-144-01542880144015 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
54288-144-105428801441010 VIAL, SINGLE-DOSE in 1 CARTON (54288-144-10) / 5 mL in 1 VIAL, SINGLE-DOSE (54288-144-01) 2025-04-01NoNoCurrent