NDC Code(s) : 61786-581-17
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

VITAMIN Dergocalciferol CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61786-581(NDC:64380-737)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ERGOCALCIFEROL(UNII: VS041H42XC)
(ERGOCALCIFEROL - UNII:VS041H42XC) 		ERGOCALCIFEROL1.25 1
Inactive Ingredients
Ingredient Name Strength
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
GELATIN(UNII: 2G86QN327L)
GLYCERIN(UNII: PDC6A3C0OX)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
WATER(UNII: 059QF0KO0R)
ETHYLENE GLYCOL MONOETHYL ETHER(UNII: IDK7C2HS09)
SOYBEAN OIL(UNII: 241ATL177A)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color green Score no score
Shape CAPSULE Size 12 mm
Flavor Imprint Code 194
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61786-581-174 in 1 BOTTLE Type 0: Not a Combination Product02/10/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090455 02/10/2016

PRINCIPAL DISPLAY PANEL

DRUG: VITAMIN D

GENERIC: ergocalciferol

DOSAGE: CAPSULE

ADMINSTRATION: ORAL

NDC: 61786-581-17

COLOR: green

SHAPE: CAPSULE

SCORE: No score

SIZE: 12 mm

IMPRINT: 194

PACKAGING: 4 in 1 BOTTLE, PLASTIC

ACTIVE INGREDIENT(S):

  • ERGOCALCIFEROL 1.25 in 1

INACTIVE INGREDIENT(S):

  • ETHYLENE GLYCOL MONOETHYL ETHER
  • FD&C YELLOW NO. 5
  • SOYBEAN OIL
  • TITANIUM DIOXIDE
  • WATER
  • GELATIN
  • GLYCERIN
  • MEDIUM-CHAIN TRIGLYCERIDES
  • LECITHIN, SOYBEAN
  • SHELLAC

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