NDC Code(s) : 51407-169-30, 51407-169-01, 51407-170-01
Packager : Golden State Medical Supply, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CalcitriolCalcitriol CAPSULE, LIQUID FILLED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-169(NDC:69452-207)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCITRIOL(UNII: FXC9231JVH)
(CALCITRIOL - UNII:FXC9231JVH) 		CALCITRIOL0.25 ug
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYANISOLE(UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
GELATIN(UNII: 2G86QN327L)
GLYCERIN(UNII: PDC6A3C0OX)
SORBITOL(UNII: 506T60A25R)
SORBITAN(UNII: 6O92ICV9RU)
MANNITOL(UNII: 3OWL53L36A)
WATER(UNII: 059QF0KO0R)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
FD&C RED NO. 40(UNII: WZB9127XOA)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Product Characteristics
Color orange (light orange) Score no score
Shape OVAL Size 10 mm
Flavor Imprint Code CAL1
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51407-169-3030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product01/03/2019
2NDC:51407-169-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product01/03/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091174 05/24/2013
CalcitriolCalcitriol CAPSULE, LIQUID FILLED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-170(NDC:69452-208)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCITRIOL(UNII: FXC9231JVH)
(CALCITRIOL - UNII:FXC9231JVH) 		CALCITRIOL0.5 ug
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYANISOLE(UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
GELATIN(UNII: 2G86QN327L)
GLYCERIN(UNII: PDC6A3C0OX)
SORBITOL(UNII: 506T60A25R)
SORBITAN(UNII: 6O92ICV9RU)
MANNITOL(UNII: 3OWL53L36A)
WATER(UNII: 059QF0KO0R)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
FD&C RED NO. 40(UNII: WZB9127XOA)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Product Characteristics
Color orange (dark orange-red) Score no score
Shape OVAL Size 10 mm
Flavor Imprint Code CAL2
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51407-170-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product01/03/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091174 05/24/2013

LABELER - Golden State Medical Supply, Inc.(603184490)

Establishment
Name Address ID/FEI Business Operations
Golden State Medical Supply Inc. 603184490 relabel(51407-169, 51407-170), repack(51407-169, 51407-170)

PRINCIPAL DISPLAY PANEL

Package Label - Principal Display Panel – 0.25 mcg, 100's Label

NDC 51407-169-01

Calcitriol Capsules

0.25 mcg

Rx only

100 Capsules

51407-169-01OL - CALCITRIOL 0.25MG CAPS - REV 1023.jpg

PRINCIPAL DISPLAY PANEL

Package Label - Principal Display Panel – 0.5 mcg, 100's Label

NDC 51407-170-01

Calcitriol Capsules

0.5 mcg

Rx only

100 Capsules

51407-170-01OL - CALCITRIOL 0.5MCG CAPS - REV 1023.jpg