FDA.reportPublic FDA data

Dehydrated Alcohol

Product NDC
54288-105
11-digit product format
542880105
Labeler code
54288
Product ID
54288-105_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
2018-10-24
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54288-105-102022-12-15C16284748780-1e4f33bdf-b265-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use ABLYSINOL ® safely and effectively. See full prescribing information for ABLYSINOL. ABLYSINOL (dehydrated alcohol) injection, for cardiac septal branch intra-arterial use Initial U.S. Approval: 1946
54288-105-152022-12-15C16284748780-1e4f33bdf-b265-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use ABLYSINOL ® safely and effectively. See full prescribing information for ABLYSINOL. ABLYSINOL (dehydrated alcohol) injection, for cardiac septal branch intra-arterial use Initial U.S. Approval: 1946
54288-105-102022-07-29C16284748780-1e4f33bdf-b265-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use ABLYSINOL ® safely and effectively. See full prescribing information for ABLYSINOL. ABLYSINOL (dehydrated alcohol) injection, for cardiac septal branch intra-arterial use Initial U.S. Approval: 1946
54288-105-152022-07-29C16284748780-1e4f33bdf-b265-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use ABLYSINOL ® safely and effectively. See full prescribing information for ABLYSINOL. ABLYSINOL (dehydrated alcohol) injection, for cardiac septal branch intra-arterial use Initial U.S. Approval: 1946

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54288-105-01Dehydrated Alcohol1 mL in 1 AMPULEINJECTION, SOLUTION112
54288-105-02Dehydrated Alcohol5 mL in 1 AMPULEINJECTION, SOLUTION512
54288-105-10Dehydrated Alcohol10 in 1 CARTONINJECTION, SOLUTION1012
54288-105-15Dehydrated Alcohol10 in 1 CARTONINJECTION, SOLUTION1012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54288-105-02ML - Milliliter54288-105a37caae1-997e-40ce-b94a-9dcccb7d5b6d12019-03-12
54288-105-15ML - Milliliter54288-10578c8f687-b3ae-4eb7-8a44-a1bb1842eec712019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54288-105DEHYDRATED ALCOHOL (ALCOHOL) INJECTION, SOLUTION [BPI LABS, LLC]10Current NDC, Legacy NDC, 4 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 startMarketing endSampleExclude flagStatus
54288-105-01542880105011 mL in 1 AMPULE1 mlHistorical
54288-105-02542880105025 mL in 1 AMPULE5 mlHistorical
54288-105-105428801051010 AMPULE in 1 CARTON (54288-105-10) / 1 mL in 1 AMPULE (54288-105-01) 10 ampule2018-10-240000-00-00NoNoCurrent
54288-105-155428801051510 AMPULE in 1 CARTON (54288-105-15) / 5 mL in 1 AMPULE (54288-105-02) 10 ampule2018-10-240000-00-00NoNoCurrent