FDA.reportPublic FDA data

Selenious Acid

Product NDC
81279-106
11-digit product format
812790106
Labeler code
81279
Product ID
81279-106_47d4b90f-3a87-05de-e063-6394a90aff35
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Selenious Acid
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Pangea Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-05-20
Substance
SELENIUM
Active strength
40 ug/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Selenious Acid
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SELENIUM40 ug/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
H6241UJ22BInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
562352Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4adcba5d-74c7-4353-b54d-539ef89754d6Available on FDA.report

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
81279-106-01Selenious Acid10 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, SOLUTION103
81279-106-05Selenious Acid5 in 1 BOXINJECTION, SOLUTION53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81279-106-01ML - Milliliter81279-1065855f09d-9fce-451d-b401-ccf4726b51c712024-06-10
81279-106-05ML - Milliliter81279-1067812a843-9435-4797-a9aa-2ad65c5b41ca12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81279-106SELENIOUS ACID INJECTION, SOLUTION [PANGEA PHARMACEUTICALS, LLC]2Current NDC, 2 package rows20240612_4adcba5d-74c7-4353-b54d-539ef89754d6.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Selenious AcidSELENIOUS ACIDPangea Pharmaceuticals, LLC4adcba5d-74c7-4353-b54d-539ef89754d62026-01-07Warnings, Adverse reactionsExact identifier
ndc (product): 81279-106

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562352selenium 400 MCG in 10 ML InjectionPSN4adcba5d-74c7-4353-b54d-539ef89754d63
56235210 ML selenious acid 0.0654 MG/ML InjectionSCD4adcba5d-74c7-4353-b54d-539ef89754d63
562352selenium 400 MCG per 10 ML InjectionSY4adcba5d-74c7-4353-b54d-539ef89754d63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81279-106-018127901060110 mL in 1 VIAL, PHARMACY BULK PACKAGE10 mlHistorical
81279-106-05812790106055 VIAL, PHARMACY BULK PACKAGE in 1 BOX (81279-106-05) / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE (81279-106-01) 2024-05-20NoNoCurrent