FDA.reportPublic FDA data

VITAMIN D

Product NDC
68788-6409
11-digit product format
687886409
Labeler code
68788
Product ID
68788-6409_871f970e-98e3-46be-aead-8d4c359a7f2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ergocalciferol
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA090455
Marketing category
ANDA
Marketing start
2016-06-08
Marketing end
0000-00-00
Substance
ERGOCALCIFEROL
Active strength
1 1/1
Pharmacologic classes
Ergocalciferols [CS],Provitamin D2 Compound [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68788-6409-12020-01-31C16284748780-19d75b9d0-e4ee-f424-e053-dadaa90a57ceVITAMIN D (Ergocalciferol Capsules, USP) 1.25mg (50,000 USP Units) Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units.
68788-6409-22020-01-31C16284748780-19d75b9d0-e4ee-f424-e053-dadaa90a57ceVITAMIN D (Ergocalciferol Capsules, USP) 1.25mg (50,000 USP Units) Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-6409-1VITAMIN D100 in 1 BOTTLE, PLASTICCAPSULE1002
68788-6409-2VITAMIN D12 in 1 BOTTLE, PLASTICCAPSULE122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-6409VITAMIN D (ERGOCALCIFEROL) CAPSULE [PREFERRED PHARMACEUTICALS INC.]2Legacy NDC, 2 package rows20170829_69b9d71f-1d7a-499a-9fc6-27437a43ef5f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1367410ergocalciferol 1.25 MG (50,000 UNT) Oral CapsulePSN69b9d71f-1d7a-499a-9fc6-27437a43ef5f2
1367410ergocalciferol 1.25 MG Oral CapsuleSCD69b9d71f-1d7a-499a-9fc6-27437a43ef5f2
1367410vit-D 1.25 MG Oral CapsuleSY69b9d71f-1d7a-499a-9fc6-27437a43ef5f2
1367410vitamin D 1.25 MG Oral CapsuleSY69b9d71f-1d7a-499a-9fc6-27437a43ef5f2
1367410vitamin D2 1250 MCG Oral CapsuleSY69b9d71f-1d7a-499a-9fc6-27437a43ef5f2
1367410vitamin D2 50,000 UNT Oral CapsuleSY69b9d71f-1d7a-499a-9fc6-27437a43ef5f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68788-6409-168788640901100 in 1 BOTTLE, PLASTICHistorical
68788-6409-26878864090212 in 1 BOTTLE, PLASTICHistorical