FDA.reportPublic FDA data

Ergocalciferol

Product NDC
43353-238
11-digit product format
433530238
Labeler code
43353
Product ID
43353-238_88018fca-ced9-4936-8361-4276c737f6bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ergocalciferol
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA080704
Marketing category
ANDA
Marketing start
2015-07-23
Substance
ERGOCALCIFEROL
Active strength
1.25 mg/1
Pharmacologic classes
Ergocalciferols [CS], Provitamin D2 Compound [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ERGOCALCIFEROL1.25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVS041H42XC
Rxcui1367410

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
a1367f07-14a3-4895-a6e7-61ee9285308bProduct name120190415
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-238-03Ergocalciferol3 in 1 BOTTLECAPSULE, LIQUID FILLED31
43353-238-04Ergocalciferol4 in 1 BOTTLECAPSULE, LIQUID FILLED41
43353-238-08Ergocalciferol8 in 1 BOTTLECAPSULE, LIQUID FILLED81
43353-238-12Ergocalciferol12 in 1 BOTTLECAPSULE, LIQUID FILLED121
43353-238-13Ergocalciferol13 in 1 BOTTLECAPSULE, LIQUID FILLED131

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-238-03EA - Each43353-23824e59a7c-5cf6-4d51-b93b-5c5e6e6cbeb112019-01-24
43353-238-04EA - Each43353-23848d8f4f5-a047-48c7-8ea5-da5a31646f3412019-01-24
43353-238-08EA - Each43353-2383346e117-dea7-4b3f-b887-534aa1cc03f012019-01-24
43353-238-12EA - Each43353-238441347b6-9120-43da-96a2-7633dbb3333f12019-01-24
43353-238-13EA - Each43353-238f138fec5-52f1-47a5-a2b6-4747673b82e612019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-238ERGOCALCIFEROL CAPSULE, LIQUID FILLED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 5 package rows20181221_2841b0ba-3b09-4f03-a060-9fb7f1af8344.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1367410ergocalciferol 1.25 MG (50,000 UNT) Oral CapsulePSN2841b0ba-3b09-4f03-a060-9fb7f1af83441
1367410ergocalciferol 1.25 MG Oral CapsuleSCD2841b0ba-3b09-4f03-a060-9fb7f1af83441
1367410vit-D 1.25 MG Oral CapsuleSY2841b0ba-3b09-4f03-a060-9fb7f1af83441
1367410vitamin D 1.25 MG Oral CapsuleSY2841b0ba-3b09-4f03-a060-9fb7f1af83441
1367410vitamin D2 1250 MCG Oral CapsuleSY2841b0ba-3b09-4f03-a060-9fb7f1af83441
1367410vitamin D2 50,000 UNT Oral CapsuleSY2841b0ba-3b09-4f03-a060-9fb7f1af83441

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-238-03433530238033 CAPSULE, LIQUID FILLED in 1 BOTTLE (43353-238-03) 2016-12-090000-00-00NoNoCurrent
43353-238-04433530238044 CAPSULE, LIQUID FILLED in 1 BOTTLE (43353-238-04) 2018-09-160000-00-00NoNoCurrent
43353-238-08433530238088 CAPSULE, LIQUID FILLED in 1 BOTTLE (43353-238-08) 2018-09-160000-00-00NoNoCurrent
43353-238-124335302381212 CAPSULE, LIQUID FILLED in 1 BOTTLE (43353-238-12) 2018-09-160000-00-00NoNoCurrent
43353-238-134335302381313 CAPSULE, LIQUID FILLED in 1 BOTTLE (43353-238-13) 2018-12-130000-00-00NoNoCurrent