FDA.reportPublic FDA data

Selenious Acid

Product NDC
0517-6502
11-digit product format
005176502
Labeler code
0517
Product ID
0517-6502_4f6657ea-8dfd-4a74-8a36-9855ca7fd34a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Selenious Acid
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
American Regent, Inc.
Application
NDA209379
Marketing category
NDA
Marketing start
2022-03-28
Substance
SELENIUM
Active strength
6 ug/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Selenious Acid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SELENIUM6 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH6241UJ22B
Rxcui2176324, 2591522

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
86fffa7b-d382-4771-a253-25cccb64b590Product name320251124
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0517-6502-01Selenious Acid2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION213
0517-6502-10Selenious Acid10 in 1 BOXINJECTION, SOLUTION1013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0517-6502-01ML - Milliliter0517-65021d152a90-47fb-4755-a06d-d8aab119a24c12022-02-07
0517-6502-10ML - Milliliter0517-6502ed79954d-3181-45f2-bfc5-537d344d655a12022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0517-6502SELENIOUS ACID INJECTION, SOLUTION [AMERICAN REGENT, INC.]13Current NDC, Legacy NDC, 2 package rows20240112_49324999-50e3-43ed-a8dd-156d6dbedd9f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2591522selenium 12 MCG in 2 ML InjectionPSN49324999-50e3-43ed-a8dd-156d6dbedd9f13
2176324selenium 60 MCG/mL Injectable SolutionPSN49324999-50e3-43ed-a8dd-156d6dbedd9f13
25915222 ML selenious acid 0.0098 MG/ML InjectionSCD49324999-50e3-43ed-a8dd-156d6dbedd9f13
2176324selenious acid 0.098 MG/ML Injectable SolutionSCD49324999-50e3-43ed-a8dd-156d6dbedd9f13
2591522selenious acid 9.8 MCG/ML per 2 ML InjectionSY49324999-50e3-43ed-a8dd-156d6dbedd9f13
2591522selenium 12 MCG per 2 ML InjectionSY49324999-50e3-43ed-a8dd-156d6dbedd9f13
2591522selenium 6 MCG/ML per 2 ML InjectionSY49324999-50e3-43ed-a8dd-156d6dbedd9f13
2176324selenium 60 MCG/ML Injectable SolutionSY49324999-50e3-43ed-a8dd-156d6dbedd9f13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0517-6502-01005176502012 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
0517-6502-100051765021010 VIAL, SINGLE-DOSE in 1 BOX (0517-6502-10) / 2 mL in 1 VIAL, SINGLE-DOSE (0517-6502-01) 2022-03-280000-00-00NoNoCurrent