PARICALCITOL

Product NDC
69387-105
11-digit product format
693870105
Labeler code
69387
Product ID
69387-105_f529b1d8-ba53-42f1-9cc4-5767f63a043d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PARICALCITOL
Dosage form
CAPSULE
Route
ORAL
Labeler
Banner Life Sciences LLC.
Application
ANDA202539
Marketing category
ANDA
Marketing start
2015-10-01
Marketing end
0000-00-00
Substance
PARICALCITOL
Active strength
4 mg/1
Pharmacologic classes
Cholecalciferol [CS],Vitamin D3 Analog [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
d92c0b9e-f894-bf80-45eb-73308b7f7f62Product name820190124
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
3c05259b-d0ee-c435-cb1a-db5d01cf3e37Product name520161206
35d6155d-80a2-4122-bd18-18decc40ac12Product name220150902

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69387-105-30PARICALCITOL30 in 1 BOTTLE, PLASTICCAPSULE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69387-105-30EA - Each69387-105b4cb3175-1c5b-4231-a44b-c916a849b01912015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PARICALCITOLACTIVE INGREDIENT6702D36OG5PARICALCITOL CAPSULE [BANNER LIFE SCIENCES LLC.]2
PARICALCITOLACTIVE MOIETY6702D36OG5PARICALCITOL CAPSULE [BANNER LIFE SCIENCES LLC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MPARICALCITOL CAPSULE [BANNER LIFE SCIENCES LLC.]2
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KPARICALCITOL CAPSULE [BANNER LIFE SCIENCES LLC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPARICALCITOL CAPSULE [BANNER LIFE SCIENCES LLC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PARICALCITOL CAPSULE [BANNER LIFE SCIENCES LLC.]2
GELATININACTIVE INGREDIENT2G86QN327LPARICALCITOL CAPSULE [BANNER LIFE SCIENCES LLC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPARICALCITOL CAPSULE [BANNER LIFE SCIENCES LLC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPARICALCITOL CAPSULE [BANNER LIFE SCIENCES LLC.]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302PARICALCITOL CAPSULE [BANNER LIFE SCIENCES LLC.]2
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UPARICALCITOL CAPSULE [BANNER LIFE SCIENCES LLC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PARICALCITOL CAPSULE [BANNER LIFE SCIENCES LLC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPARICALCITOL CAPSULE [BANNER LIFE SCIENCES LLC.]2
WATERINACTIVE INGREDIENT059QF0KO0RPARICALCITOL CAPSULE [BANNER LIFE SCIENCES LLC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69387-105PARICALCITOL CAPSULE [BANNER LIFE SCIENCES LLC.]2Legacy NDC, 1 package rows20151001_108e4cb1-6e43-44fd-b228-cd23203fccda.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
69387-105-306938701053030 in 1 BOTTLE, PLASTICHistorical