FDA.reportPublic FDA data

Ergocalciferol

Product NDC
42291-266
11-digit product format
422910266
Labeler code
42291
Product ID
42291-266_450e6d57-a62c-12f5-e063-6294a90a01a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ergocalciferol
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
AvKARE
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
42291-266-01Ergocalciferol100 in 1 BOTTLECAPSULE, LIQUID FILLED1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-266-01EA - Each42291-26625027859-9c7c-4b06-9a4e-baa2df95f9bb12015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ErgocalciferolACTIVE INGREDIENTVS041H42XCERGOCALCIFEROL (ERGOCALCIFEROL) CAPSULE, LIQUID FILLED [AVKARE, INC.]2
ErgocalciferolACTIVE MOIETYVS041H42XCERGOCALCIFEROL (ERGOCALCIFEROL) CAPSULE, LIQUID FILLED [AVKARE, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GERGOCALCIFEROL (ERGOCALCIFEROL) CAPSULE, LIQUID FILLED [AVKARE, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDERGOCALCIFEROL (ERGOCALCIFEROL) CAPSULE, LIQUID FILLED [AVKARE, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LERGOCALCIFEROL (ERGOCALCIFEROL) CAPSULE, LIQUID FILLED [AVKARE, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXERGOCALCIFEROL (ERGOCALCIFEROL) CAPSULE, LIQUID FILLED [AVKARE, INC.]2
SOYBEAN OILINACTIVE INGREDIENT241ATL177AERGOCALCIFEROL (ERGOCALCIFEROL) CAPSULE, LIQUID FILLED [AVKARE, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RERGOCALCIFEROL (ERGOCALCIFEROL) CAPSULE, LIQUID FILLED [AVKARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-266ERGOCALCIFEROL CAPSULE, LIQUID FILLED [AVKARE]7Current NDC, Legacy NDC, 1 package rows20220114_f55eafcd-dfd9-fdae-c39f-ae07aa852ce1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1367410ergocalciferol 1.25 MG (50,000 UNT) Oral CapsulePSNf55eafcd-dfd9-fdae-c39f-ae07aa852ce18
1367410ergocalciferol 1.25 MG Oral CapsuleSCDf55eafcd-dfd9-fdae-c39f-ae07aa852ce18
1367410vit-D 1.25 MG Oral CapsuleSYf55eafcd-dfd9-fdae-c39f-ae07aa852ce18
1367410vitamin D 1.25 MG Oral CapsuleSYf55eafcd-dfd9-fdae-c39f-ae07aa852ce18
1367410vitamin D2 1250 MCG Oral CapsuleSYf55eafcd-dfd9-fdae-c39f-ae07aa852ce18
1367410vitamin D2 50,000 UNT Oral CapsuleSYf55eafcd-dfd9-fdae-c39f-ae07aa852ce18
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
42291-266-0142291026601100 CAPSULE, LIQUID FILLED in 1 BOTTLE (42291-266-01) 2015-07-230000-00-00NoNoCurrent