Calcitriol: Package Insert and Label Information (Page 3 of 3)

Package/Label Display Panel — Blister — 0.25 mcg

Card Print Calcitriol 0.25 mcg
(click image for full-size original)

CALCITRIOL
CAPSULES

0.25 mcg

CALCITRIOL
calcitriol capsules 0.25 mcg capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-345(NDC:64380-723)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCITRIOL (CALCITRIOL) CALCITRIOL 0.25 ug
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYANISOLE
BUTYLATED HYDROXYTOLUENE
MEDIUM-CHAIN TRIGLYCERIDES
GLYCERIN
SORBITOL
FD&C YELLOW NO. 6
FD&C RED NO. 3
TITANIUM DIOXIDE
Product Characteristics
Color orange Score no score
Shape OVAL Size 10mm
Flavor Imprint Code 673
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60687-345-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (60687-345-11)
1 NDC:60687-345-11 1 CAPSULE in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (60687-345-01)
Image of Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091356 01/23/2019
Labeler — American Health Packaging (929561009)
Establishment
Name Address ID/FEI Operations
American Health Packaging 929561009 repack (60687-345)

Revised: 10/2022 American Health Packaging

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