FDA.reportPublic FDA data

Dehydrated Alcohol

Product NDC
62250-105
11-digit product format
622500105
Labeler code
62250
Product ID
62250-105_d2d30cbc-6af1-a8a2-e053-2a95a90a682e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alcohol
Dosage form
INJECTION, SOLUTION
Route
PERCUTANEOUS
Labeler
Belcher Pharmaceuticals, LLC
Application
NDA207987
Marketing category
NDA
Marketing start
2018-07-02
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
1 mL/mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62250-105-102022-07-29C16284748780-1e4f33bdf-9b45-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
62250-105-152022-07-29C16284748780-1e4f33bdf-9b45-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
62250-105-01Dehydrated Alcohol1 mL in 1 AMPULEINJECTION, SOLUTION16
62250-105-02Dehydrated Alcohol5 mL in 1 AMPULEINJECTION, SOLUTION56
62250-105-10Dehydrated Alcohol10 in 1 CARTONINJECTION, SOLUTION106
62250-105-15Dehydrated Alcohol10 in 1 CARTONINJECTION, SOLUTION106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62250-105DEHYDRATED ALCOHOL (ALCOHOL) INJECTION, SOLUTION [BELCHER PHARMACEUTICALS, LLC]6Legacy NDC, 4 package rows20211212_379e7c93-14a7-42d0-920f-a6b5eca34b99.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2048979ethanol 99 % in 1 ML InjectionPSN379e7c93-14a7-42d0-920f-a6b5eca34b996
2048982ethanol 99 % in 5 ML InjectionPSN379e7c93-14a7-42d0-920f-a6b5eca34b996
20489791 ML ethanol 0.99 ML/ML InjectionSCD379e7c93-14a7-42d0-920f-a6b5eca34b996
20489825 ML ethanol 0.99 ML/ML InjectionSCD379e7c93-14a7-42d0-920f-a6b5eca34b996
2048979ethanol 99 % per 1 ML InjectionSY379e7c93-14a7-42d0-920f-a6b5eca34b996
2048982ethanol 99 % per 5 ML InjectionSY379e7c93-14a7-42d0-920f-a6b5eca34b996

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62250-105-01622500105011 mL in 1 AMPULE1 mlHistorical
62250-105-02622500105025 mL in 1 AMPULE5 mlHistorical
62250-105-106225001051010 AMPULE in 1 CARTON (62250-105-10) > 1 mL in 1 AMPULE (62250-105-01) 10 ampule2018-07-020000-00-00NoNoCurrent
62250-105-156225001051510 AMPULE in 1 CARTON (62250-105-15) > 5 mL in 1 AMPULE (62250-105-02) 10 ampule2018-07-020000-00-00NoNoCurrent