FDA.reportPublic FDA data

VITAMIN D

Product NDC
53217-287
11-digit product format
532170287
Labeler code
53217
Product ID
53217-287_4774d269-7226-47d4-aa21-11cd3dc2fd1a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ergocalciferol
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA090455
Marketing category
ANDA
Marketing start
2014-05-16
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
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
53217-287-082020-01-31C16284748780-19d75b9d0-da92-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.
53217-287-122020-01-31C16284748780-19d75b9d0-da92-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.
53217-287-132020-01-31C16284748780-19d75b9d0-da92-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.
53217-287-302020-01-31C16284748780-19d75b9d0-da92-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
53217-287-08VITAMIN D8 in 1 BOTTLECAPSULE81
53217-287-12VITAMIN D12 in 1 BOTTLECAPSULE121
53217-287-13VITAMIN D4 in 1 BOTTLECAPSULE41
53217-287-30VITAMIN D30 in 1 BOTTLECAPSULE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-287-08EA - Each53217-287e5c1c572-a038-4ac3-b6b3-dd945ffb560c12017-06-15
53217-287-12EA - Each53217-2878503ff01-e7c0-46eb-95d7-e4e99c3a2f5312017-06-15
53217-287-13EA - Each53217-287bc1c343c-9742-4677-91a4-dd04701c83e412017-06-15
53217-287-30EA - Each53217-2878900d946-b440-4947-a643-8be87bb9c5b412017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-287VITAMIN D (ERGOCALCIFEROL) CAPSULE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 4 package rows20170428_a9e8ee4e-c0be-4273-853f-332df38046ac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1367410ergocalciferol 1.25 MG (50,000 UNT) Oral CapsulePSNa9e8ee4e-c0be-4273-853f-332df38046ac1
1367410ergocalciferol 1.25 MG Oral CapsuleSCDa9e8ee4e-c0be-4273-853f-332df38046ac1
1367410vit-D 1.25 MG Oral CapsuleSYa9e8ee4e-c0be-4273-853f-332df38046ac1
1367410vitamin D 1.25 MG Oral CapsuleSYa9e8ee4e-c0be-4273-853f-332df38046ac1
1367410vitamin D2 1250 MCG Oral CapsuleSYa9e8ee4e-c0be-4273-853f-332df38046ac1
1367410vitamin D2 50,000 UNT Oral CapsuleSYa9e8ee4e-c0be-4273-853f-332df38046ac1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-287-08532170287088 in 1 BOTTLEHistorical
53217-287-125321702871212 in 1 BOTTLEHistorical
53217-287-13532170287134 in 1 BOTTLEHistorical
53217-287-305321702873030 in 1 BOTTLEHistorical