VITAMIN D

Product NDC
43353-828
11-digit product format
433530828
Labeler code
43353
Product ID
43353-828_9e948241-a8c1-46e2-98c8-9c10893556b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ergocalciferol
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA040865
Marketing category
ANDA
Marketing start
2010-03-15
Marketing end
0000-00-00
Substance
ERGOCALCIFEROL
Active strength
1 mg/1
Pharmacologic classes
Ergocalciferols [CS],Provitamin D2 Compound [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43353-828-032020-01-31C16284748780-19d75b9d0-ee87-f424-e053-dadaa90a57ce15f453ac-84b6-455e-9926-f51b8b9ac0dd
43353-828-042020-01-31C16284748780-19d75b9d0-ee87-f424-e053-dadaa90a57ce15f453ac-84b6-455e-9926-f51b8b9ac0dd

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-828-03VITAMIN D3 in 1 BOTTLE, PLASTICCAPSULE31
43353-828-04VITAMIN D4 in 1 BOTTLE, PLASTICCAPSULE41

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-828-03EA - Each43353-8283da2b58f-9bc8-4395-9baf-cc44bf79ef8b12014-01-04
43353-828-04EA - Each43353-828b1f75ca7-790a-4c77-bdb4-c011031f222512014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ERGOCALCIFEROLACTIVE INGREDIENTVS041H42XCVITAMIN D (ERGOCALCIFEROL) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
ERGOCALCIFEROLACTIVE MOIETYVS041H42XCVITAMIN D (ERGOCALCIFEROL) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XVITAMIN D (ERGOCALCIFEROL) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3VITAMIN D (ERGOCALCIFEROL) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GVITAMIN D (ERGOCALCIFEROL) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OVITAMIN D (ERGOCALCIFEROL) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDVITAMIN D (ERGOCALCIFEROL) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
GELATININACTIVE INGREDIENT2G86QN327LVITAMIN D (ERGOCALCIFEROL) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXVITAMIN D (ERGOCALCIFEROL) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302VITAMIN D (ERGOCALCIFEROL) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3VITAMIN D (ERGOCALCIFEROL) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SHELLACINACTIVE INGREDIENT46N107B71OVITAMIN D (ERGOCALCIFEROL) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SOYBEAN OILINACTIVE INGREDIENT241ATL177AVITAMIN D (ERGOCALCIFEROL) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVITAMIN D (ERGOCALCIFEROL) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RVITAMIN D (ERGOCALCIFEROL) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-828VITAMIN D (ERGOCALCIFEROL) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 2 package rows20130731_15f453ac-84b6-455e-9926-f51b8b9ac0dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1367410ergocalciferol 1.25 MG (50,000 UNT) Oral CapsulePSN15f453ac-84b6-455e-9926-f51b8b9ac0dd1
1367410ergocalciferol 1.25 MG Oral CapsuleSCD15f453ac-84b6-455e-9926-f51b8b9ac0dd1
1367410vit-D 1.25 MG Oral CapsuleSY15f453ac-84b6-455e-9926-f51b8b9ac0dd1
1367410vitamin D 1.25 MG Oral CapsuleSY15f453ac-84b6-455e-9926-f51b8b9ac0dd1
1367410vitamin D2 1250 MCG Oral CapsuleSY15f453ac-84b6-455e-9926-f51b8b9ac0dd1
1367410vitamin D2 50,000 UNT Oral CapsuleSY15f453ac-84b6-455e-9926-f51b8b9ac0dd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-828-03433530828033 in 1 BOTTLE, PLASTICHistorical
43353-828-04433530828044 in 1 BOTTLE, PLASTICHistorical