Indomethacin (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 72578-038-01

Indomethacin capsules USP, 25 mg

100 Capsules

Rx only

Indomethacin Capsules, USP
(click image for full-size original)

NDC 72578-039-01

Indomethacin capsules USP, 50 mg

100 Capsules

Rx only

IndomethacineCapsules, USP
(click image for full-size original)
INDOMETHACIN indomethacin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72578-038
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INDOMETHACIN (INDOMETHACIN) INDOMETHACIN 25 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
FD&C BLUE NO. 1
FD&C YELLOW NO. 5
FERROSOFERRIC OXIDE
GELATIN
MAGNESIUM STEARATE
POWDERED CELLULOSE
SILICON DIOXIDE
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A CORN
TITANIUM DIOXIDE
Product Characteristics
Color GREEN (GREEN) Score no score
Shape CAPSULE (CAPSULE) Size 16mm
Flavor Imprint Code 293
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72578-038-01 100 CAPSULE in 1 BOTTLE None
2 NDC:72578-038-10 1000 CAPSULE in 1 BOTTLE None
3 NDC:72578-038-05 500 CAPSULE in 1 BOTTLE None
4 NDC:72578-038-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (72578-038-30)
4 NDC:72578-038-30 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (72578-038-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090403 06/20/2019
INDOMETHACIN indomethacin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72578-039
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INDOMETHACIN (INDOMETHACIN) INDOMETHACIN 50 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
FD&C BLUE NO. 1
FD&C YELLOW NO. 5
FERROSOFERRIC OXIDE
GELATIN
MAGNESIUM STEARATE
POWDERED CELLULOSE
SILICON DIOXIDE
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A CORN
TITANIUM DIOXIDE
Product Characteristics
Color GREEN (GREEN) Score no score
Shape CAPSULE (CAPSULE) Size 19mm
Flavor Imprint Code 294
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72578-039-01 100 CAPSULE in 1 BOTTLE None
2 NDC:72578-039-05 500 CAPSULE in 1 BOTTLE None
3 NDC:72578-039-10 1000 CAPSULE in 1 BOTTLE None
4 NDC:72578-039-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (72578-039-30)
4 NDC:72578-039-30 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (72578-039-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090403 06/20/2019
Labeler — Viona Pharmaceuticals Inc (081468959)
Registrant — Cadila Healthcare Limited Zydus Tower (650199482)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS (72578-038), ANALYSIS (72578-039), MANUFACTURE (72578-038), MANUFACTURE (72578-039)

Revised: 06/2021 Viona Pharmaceuticals Inc

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