Calcitriol (Page 5 of 5)

HOW SUPPLIED

Calcitriol capsules are available as follows:

0.25 mcg — opaque, red-brown and yellow-brown, two-tone, oval, soft, gelatin capsules, imprinted “93” and “657”, in bottles of 100 (NDC 0093-7352-01).

0.5 mcg — opaque, brown and pink, two-tone, oblong, soft, gelatin capsules, imprinted “93” and “658”, in bottles of 100 (NDC 0093-7353-01).

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light.

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

REFERENCE

  1. Jones CL, et al. Comparisons between oral and intraperitoneal 1,25-dihydroxy-vitamin D3 therapy in children treated with peritoneal dialysis. Clin Nephrol. 1994;42:44-49.

Manufactured In Germany By:

Catalent Germany Eberbach GmbH

Eberbach, Baden 69412, Germany

Manufactured For:

Teva Pharmaceuticals USA, Inc.

North Wales, PA 19454

Rev. I 8/2019

Package/Label Display Panel

NDC 0093-7352 -01

Calcitriol Capsules 0.25 mcg

Rx only

100 CAPSULES

TEVA

new label
(click image for full-size original)

Package/Label Display Panel

NDC 0093-7353 -01

Calcitriol Capsules 0.5 mcg

Rx only

100 CAPSULES

TEVA

new
(click image for full-size original)
CALCITRIOL
calcitriol capsule, liquid filled
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-7353
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCITRIOL (CALCITRIOL) CALCITRIOL 0.5 ug
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYANISOLE
BUTYLATED HYDROXYTOLUENE
MEDIUM-CHAIN TRIGLYCERIDES
GELATIN
GLYCERIN
MANNITOL
FERRIC OXIDE RED
SORBITOL
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
PROPYLENE GLYCOL
Product Characteristics
Color brown, pink Score no score
Shape OVAL (oblong) Size 13mm
Flavor Imprint Code 93;658
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-7353-01 100 CAPSULE, LIQUID FILLED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075765 07/01/2016
CALCITRIOL
calcitriol capsule, liquid filled
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-7352
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
GELATIN
GLYCERIN
MANNITOL
FERRIC OXIDE RED
SORBITOL
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
PROPYLENE GLYCOL
Product Characteristics
Color red (red-brown) , yellow (yellow-brown) Score no score
Shape OVAL Size 10mm
Flavor Imprint Code 93;657
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-7352-01 100 CAPSULE, LIQUID FILLED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075765 08/25/2016
Labeler — Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 08/2019 Teva Pharmaceuticals USA, Inc.

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