FDA.reportPublic FDA data

Ergocalciferol

Product NDC
69452-151
11-digit product format
694520151
Labeler code
69452
Product ID
69452-151_44ea5b7f-37c7-ed1d-e063-6294a90ab33f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ergocalciferol
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA080704
Marketing category
ANDA
Marketing start
2016-06-15
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
69452-151-20Ergocalciferol100 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69452-151-20EA - Each69452-1510126c1f8-038e-4f90-a635-5bed4ed4696b12016-07-19

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
69452-151ERGOCALCIFEROL CAPSULE, LIQUID FILLED [BIONPHARMA INC.]6Current NDC, Legacy NDC, 1 package rows20241222_2a8d73d6-9991-401b-ab8b-81f22e5a0695.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1367410ergocalciferol 1.25 MG (50,000 UNT) Oral CapsulePSN0d230fd8-2ea7-4dd6-a506-5f7804e539fc103
1367410ergocalciferol 1.25 MG Oral CapsuleSCD0d230fd8-2ea7-4dd6-a506-5f7804e539fc103
1367410vit-D 1.25 MG Oral CapsuleSY0d230fd8-2ea7-4dd6-a506-5f7804e539fc103
1367410vitamin D 1.25 MG Oral CapsuleSY0d230fd8-2ea7-4dd6-a506-5f7804e539fc103
1367410vitamin D2 1250 MCG Oral CapsuleSY0d230fd8-2ea7-4dd6-a506-5f7804e539fc103
1367410vitamin D2 50,000 UNT Oral CapsuleSY0d230fd8-2ea7-4dd6-a506-5f7804e539fc103
1367410ergocalciferol 1.25 MG (50,000 UNT) Oral CapsulePSNa80436e0-b507-4e7b-9a60-a9d5ddc4a04523
1367410ergocalciferol 1.25 MG Oral CapsuleSCDa80436e0-b507-4e7b-9a60-a9d5ddc4a04523
1367410vit-D 1.25 MG Oral CapsuleSYa80436e0-b507-4e7b-9a60-a9d5ddc4a04523
1367410vitamin D 1.25 MG Oral CapsuleSYa80436e0-b507-4e7b-9a60-a9d5ddc4a04523
1367410vitamin D2 1250 MCG Oral CapsuleSYa80436e0-b507-4e7b-9a60-a9d5ddc4a04523
1367410vitamin D2 50,000 UNT Oral CapsuleSYa80436e0-b507-4e7b-9a60-a9d5ddc4a04523
1367410ergocalciferol 1.25 MG (50,000 UNT) Oral CapsulePSN2475e731-0072-4787-8a40-09137883c62519
1367410ergocalciferol 1.25 MG Oral CapsuleSCD2475e731-0072-4787-8a40-09137883c62519
1367410vit-D 1.25 MG Oral CapsuleSY2475e731-0072-4787-8a40-09137883c62519
1367410vitamin D 1.25 MG Oral CapsuleSY2475e731-0072-4787-8a40-09137883c62519
1367410vitamin D2 1250 MCG Oral CapsuleSY2475e731-0072-4787-8a40-09137883c62519
1367410vitamin D2 50,000 UNT Oral CapsuleSY2475e731-0072-4787-8a40-09137883c62519
1367410ergocalciferol 1.25 MG (50,000 UNT) Oral CapsulePSN39b72d09-cedc-4130-89a3-1ea03f58ba0412
1367410ergocalciferol 1.25 MG Oral CapsuleSCD39b72d09-cedc-4130-89a3-1ea03f58ba0412
1367410vit-D 1.25 MG Oral CapsuleSY39b72d09-cedc-4130-89a3-1ea03f58ba0412
1367410vitamin D 1.25 MG Oral CapsuleSY39b72d09-cedc-4130-89a3-1ea03f58ba0412
1367410vitamin D2 1250 MCG Oral CapsuleSY39b72d09-cedc-4130-89a3-1ea03f58ba0412
1367410vitamin D2 50,000 UNT Oral CapsuleSY39b72d09-cedc-4130-89a3-1ea03f58ba0412
1367410ergocalciferol 1.25 MG (50,000 UNT) Oral CapsulePSN492452d6-2b32-39c0-e054-00144ff8d46c10
1367410ergocalciferol 1.25 MG Oral CapsuleSCD492452d6-2b32-39c0-e054-00144ff8d46c10
1367410vit-D 1.25 MG Oral CapsuleSY492452d6-2b32-39c0-e054-00144ff8d46c10
1367410vitamin D 1.25 MG Oral CapsuleSY492452d6-2b32-39c0-e054-00144ff8d46c10
1367410vitamin D2 1250 MCG Oral CapsuleSY492452d6-2b32-39c0-e054-00144ff8d46c10
1367410vitamin D2 50,000 UNT Oral CapsuleSY492452d6-2b32-39c0-e054-00144ff8d46c10
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 CapsulePSN2a8d73d6-9991-401b-ab8b-81f22e5a06957
1367410ergocalciferol 1.25 MG Oral CapsuleSCD2a8d73d6-9991-401b-ab8b-81f22e5a06957
1367410vit-D 1.25 MG Oral CapsuleSY2a8d73d6-9991-401b-ab8b-81f22e5a06957
1367410vitamin D 1.25 MG Oral CapsuleSY2a8d73d6-9991-401b-ab8b-81f22e5a06957
1367410vitamin D2 1250 MCG Oral CapsuleSY2a8d73d6-9991-401b-ab8b-81f22e5a06957
1367410vitamin D2 50,000 UNT Oral CapsuleSY2a8d73d6-9991-401b-ab8b-81f22e5a06957
1367410ergocalciferol 1.25 MG (50,000 UNT) Oral CapsulePSNc538ac91-2507-4f42-8f7a-013510539b306
1367410ergocalciferol 1.25 MG Oral CapsuleSCDc538ac91-2507-4f42-8f7a-013510539b306
1367410vit-D 1.25 MG Oral CapsuleSYc538ac91-2507-4f42-8f7a-013510539b306
1367410vitamin D 1.25 MG Oral CapsuleSYc538ac91-2507-4f42-8f7a-013510539b306
1367410vitamin D2 1250 MCG Oral CapsuleSYc538ac91-2507-4f42-8f7a-013510539b306
1367410vitamin D2 50,000 UNT Oral CapsuleSYc538ac91-2507-4f42-8f7a-013510539b306
1367410ergocalciferol 1.25 MG (50,000 UNT) Oral CapsulePSNc4793165-6647-4dba-b100-3986739cd01e5
1367410ergocalciferol 1.25 MG (50,000 UNT) Oral CapsulePSN5f4ef344-7880-3375-e053-2a91aa0a47b85
1367410ergocalciferol 1.25 MG Oral CapsuleSCD5f4ef344-7880-3375-e053-2a91aa0a47b85
1367410ergocalciferol 1.25 MG Oral CapsuleSCDc4793165-6647-4dba-b100-3986739cd01e5
1367410vit-D 1.25 MG Oral CapsuleSY5f4ef344-7880-3375-e053-2a91aa0a47b85
1367410vit-D 1.25 MG Oral CapsuleSYc4793165-6647-4dba-b100-3986739cd01e5
1367410vitamin D 1.25 MG Oral CapsuleSYc4793165-6647-4dba-b100-3986739cd01e5
1367410vitamin D 1.25 MG Oral CapsuleSY5f4ef344-7880-3375-e053-2a91aa0a47b85
1367410vitamin D2 1250 MCG Oral CapsuleSY5f4ef344-7880-3375-e053-2a91aa0a47b85
1367410vitamin D2 1250 MCG Oral CapsuleSYc4793165-6647-4dba-b100-3986739cd01e5
1367410vitamin D2 50,000 UNT Oral CapsuleSY5f4ef344-7880-3375-e053-2a91aa0a47b85
1367410vitamin D2 50,000 UNT Oral CapsuleSYc4793165-6647-4dba-b100-3986739cd01e5
1367410ergocalciferol 1.25 MG (50,000 UNT) Oral CapsulePSN84647b52-3c4c-31bb-e053-2991aa0a8a7e2
1367410ergocalciferol 1.25 MG Oral CapsuleSCD84647b52-3c4c-31bb-e053-2991aa0a8a7e2
1367410vit-D 1.25 MG Oral CapsuleSY84647b52-3c4c-31bb-e053-2991aa0a8a7e2
1367410vitamin D 1.25 MG Oral CapsuleSY84647b52-3c4c-31bb-e053-2991aa0a8a7e2
1367410vitamin D2 1250 MCG Oral CapsuleSY84647b52-3c4c-31bb-e053-2991aa0a8a7e2
1367410vitamin D2 50,000 UNT Oral CapsuleSY84647b52-3c4c-31bb-e053-2991aa0a8a7e2
1367410ergocalciferol 1.25 MG (50,000 UNT) Oral CapsulePSN1cd4afc6-ef90-4e7b-9f11-2bfbd137524c1
1367410ergocalciferol 1.25 MG Oral CapsuleSCD1cd4afc6-ef90-4e7b-9f11-2bfbd137524c1
1367410vit-D 1.25 MG Oral CapsuleSY1cd4afc6-ef90-4e7b-9f11-2bfbd137524c1
1367410vitamin D 1.25 MG Oral CapsuleSY1cd4afc6-ef90-4e7b-9f11-2bfbd137524c1
1367410vitamin D2 1250 MCG Oral CapsuleSY1cd4afc6-ef90-4e7b-9f11-2bfbd137524c1
1367410vitamin D2 50,000 UNT Oral CapsuleSY1cd4afc6-ef90-4e7b-9f11-2bfbd137524c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69452-151-2069452015120100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69452-151-20) 2016-06-150000-00-00NoNoCurrent