Hydroxocobalamin

Product NDC
50090-3548
11-digit product format
500903548
Labeler code
50090
Product ID
50090-3548_2f0c3858-5acc-4974-9be7-71ecdaecbcf2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxocobalamin
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
A-S Medication Solutions
Application
ANDA085998
Marketing category
ANDA
Marketing start
2010-11-12
Marketing end
0000-00-00
Substance
HYDROXOCOBALAMIN ACETATE
Active strength
1000 ug/mL
Pharmacologic classes
Antidote [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3548-02023-01-30C16284748780-1f386c64a-2804-0266-e053-dadaa90a7c1aHYDROXOCOBALAMIN INJECTION USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3548-0Hydroxocobalamin30 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION304
50090-3548-0Hydroxocobalamin1 in 1 CARTONINJECTION, SOLUTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3548HYDROXOCOBALAMIN INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]4Legacy NDC, 2 package rows20200121_17e7d7d8-d27c-4888-84b9-45305df62066.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317106hydroxocobalamin 1000 MCG/ML Injectable SolutionPSN17e7d7d8-d27c-4888-84b9-45305df620664
317106hydroxocobalamin 1 MG/ML Injectable SolutionSCD17e7d7d8-d27c-4888-84b9-45305df620664
317106hydroxocobalamin (as hydroxocobalamin acetate) 1000 MCG/ML Injectable SolutionSY17e7d7d8-d27c-4888-84b9-45305df620664
317106hydroxocobalamin 1000 MCG/ML Injectable SolutionSY17e7d7d8-d27c-4888-84b9-45305df620664

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3548-0500903548001 VIAL, MULTI-DOSE in 1 CARTON (50090-3548-0) > 30 mL in 1 VIAL, MULTI-DOSE2018-08-230000-00-00NoNoCurrent