FDA.reportPublic FDA data

Ergocalciferol

Product NDC
51991-604
11-digit product format
519910604
Labeler code
51991
Product ID
51991-604_46db4e66-96a9-4170-b637-a74514ec9fec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ergocalciferol
Dosage form
CAPSULE
Route
ORAL
Labeler
Breckenridge Pharmaceutical, Inc.
Application
ANDA040833
Marketing category
ANDA
Marketing start
2009-08-17
Marketing end
2019-10-31
Substance
ERGOCALCIFEROL
Active strength
1 mg/1
Pharmacologic classes
Ergocalciferols [CS],Provitamin D2 Compound [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51991-604-01EA - Each51991-60421fafdc5-83d9-484e-bf87-dcbbb236bbd012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ERGOCALCIFEROLACTIVE INGREDIENTVS041H42XCERGOCALCIFEROL CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
ERGOCALCIFEROLACTIVE MOIETYVS041H42XCERGOCALCIFEROL CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GERGOCALCIFEROL CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDERGOCALCIFEROL CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LERGOCALCIFEROL CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXERGOCALCIFEROL CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
SOYBEAN OILINACTIVE INGREDIENT241ATL177AERGOCALCIFEROL CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RERGOCALCIFEROL CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
ERGOCALCIFEROLACTIVE INGREDIENTVS041H42XCERGOCALCIFEROL CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
ERGOCALCIFEROLACTIVE INGREDIENTVS041H42XCERGOCALCIFEROL CAPSULE [BLENHEIM PHARMACAL, INC.]1
ErgocalciferolACTIVE INGREDIENTVS041H42XCERGOCALCIFEROL CAPSULE [DISPENSING SOLUTIONS, INC.]1
ErgocalciferolACTIVE MOIETYVS041H42XCERGOCALCIFEROL CAPSULE [DISPENSING SOLUTIONS, INC.]1
ERGOCALCIFEROLACTIVE MOIETYVS041H42XCERGOCALCIFEROL CAPSULE [BLENHEIM PHARMACAL, INC.]1
ERGOCALCIFEROLACTIVE MOIETYVS041H42XCERGOCALCIFEROL CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GERGOCALCIFEROL CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GERGOCALCIFEROL CAPSULE [DISPENSING SOLUTIONS, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GERGOCALCIFEROL CAPSULE [BLENHEIM PHARMACAL, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDERGOCALCIFEROL CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDERGOCALCIFEROL CAPSULE [BLENHEIM PHARMACAL, INC.]1
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDERGOCALCIFEROL CAPSULE [DISPENSING SOLUTIONS, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LERGOCALCIFEROL CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
GelatinINACTIVE INGREDIENT2G86QN327LERGOCALCIFEROL CAPSULE [DISPENSING SOLUTIONS, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LERGOCALCIFEROL CAPSULE [BLENHEIM PHARMACAL, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXERGOCALCIFEROL CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXERGOCALCIFEROL CAPSULE [DISPENSING SOLUTIONS, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXERGOCALCIFEROL CAPSULE [BLENHEIM PHARMACAL, INC.]1
SOYBEAN OILINACTIVE INGREDIENT241ATL177AERGOCALCIFEROL CAPSULE [BLENHEIM PHARMACAL, INC.]1
Soybean OilINACTIVE INGREDIENT241ATL177AERGOCALCIFEROL CAPSULE [DISPENSING SOLUTIONS, INC.]1
SOYBEAN OILINACTIVE INGREDIENT241ATL177AERGOCALCIFEROL CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RERGOCALCIFEROL CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
WaterINACTIVE INGREDIENT059QF0KO0RERGOCALCIFEROL CAPSULE [DISPENSING SOLUTIONS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RERGOCALCIFEROL CAPSULE [BLENHEIM PHARMACAL, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1367410ergocalciferol 1.25 MG (50,000 UNT) Oral CapsulePSN5ed8aad8-99ce-41e7-8c3d-26ecaf5599fd1
1367410ergocalciferol 1.25 MG (50,000 UNT) Oral CapsulePSN0525e04f-91b7-4d75-8ff9-a6fb5705d9931
1367410ergocalciferol 1.25 MG (50,000 UNT) Oral CapsulePSN0fefb3a2-f0c6-0544-e054-00144ff8d46c1
1367410ergocalciferol 1.25 MG Oral CapsuleSCD5ed8aad8-99ce-41e7-8c3d-26ecaf5599fd1
1367410ergocalciferol 1.25 MG Oral CapsuleSCD0525e04f-91b7-4d75-8ff9-a6fb5705d9931
1367410ergocalciferol 1.25 MG Oral CapsuleSCD0fefb3a2-f0c6-0544-e054-00144ff8d46c1
1367410vit-D 1.25 MG Oral CapsuleSY5ed8aad8-99ce-41e7-8c3d-26ecaf5599fd1
1367410vit-D 1.25 MG Oral CapsuleSY0fefb3a2-f0c6-0544-e054-00144ff8d46c1
1367410vit-D 1.25 MG Oral CapsuleSY0525e04f-91b7-4d75-8ff9-a6fb5705d9931
1367410vitamin D 1.25 MG Oral CapsuleSY0fefb3a2-f0c6-0544-e054-00144ff8d46c1
1367410vitamin D 1.25 MG Oral CapsuleSY5ed8aad8-99ce-41e7-8c3d-26ecaf5599fd1
1367410vitamin D 1.25 MG Oral CapsuleSY0525e04f-91b7-4d75-8ff9-a6fb5705d9931
1367410vitamin D2 1250 MCG Oral CapsuleSY0fefb3a2-f0c6-0544-e054-00144ff8d46c1
1367410vitamin D2 1250 MCG Oral CapsuleSY5ed8aad8-99ce-41e7-8c3d-26ecaf5599fd1
1367410vitamin D2 1250 MCG Oral CapsuleSY0525e04f-91b7-4d75-8ff9-a6fb5705d9931
1367410vitamin D2 50,000 UNT Oral CapsuleSY0fefb3a2-f0c6-0544-e054-00144ff8d46c1
1367410vitamin D2 50,000 UNT Oral CapsuleSY5ed8aad8-99ce-41e7-8c3d-26ecaf5599fd1
1367410vitamin D2 50,000 UNT Oral CapsuleSY0525e04f-91b7-4d75-8ff9-a6fb5705d9931