Isotretinoin: Package Insert and Label Information

ISOTRETINOIN- isotretinoin powder
BLUEBAY SHANDONG CO.,LTD

Isotretinoin

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ISOTRETINOIN
isotretinoin powder
Product Information
Product Type BULK INGREDIENT Item Code (Source) NDC:73309-342
Route of Administration NOT APPLICABLE DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOTRETINOIN (ISOTRETINOIN) ISOTRETINOIN 1 g in 1 g
Product Characteristics
Color yellow Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73309-342-01 1000 g in 1 JAR None
2 NDC:73309-342-02 100 g in 1 JAR None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
bulk ingredient for animal drug compounding 11/19/2021
Labeler — BLUEBAY SHANDONG CO.,LTD (554492641)
Establishment
Name Address ID/FEI Operations
BLUEBAY SHANDONG CO.,LTD 554492641 relabel (73309-342)

Revised: 11/2021 BLUEBAY SHANDONG CO.,LTD

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