Indomethacin

INDOMETHACIN- indomethacin capsule, extended release
Cadila Healthcare Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1203-6

Indomethacin Extended-release Capsules, 75 mg

60 Capsules

Rx only

label
(click image for full-size original)
INDOMETHACIN
indomethacin capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1203
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INDOMETHACIN (INDOMETHACIN) INDOMETHACIN 75 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
FD&C BLUE NO. 1
HYPROMELLOSES
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
GELATIN
SHELLAC
PROPYLENE GLYCOL
AMMONIA
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
WATER
Product Characteristics
Color BLUE (DARK BLUE) , BLUE (DARK BLUE) Score no score
Shape CAPSULE (CAPSULE) Size 19mm
Flavor Imprint Code ZA;79;75mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1203-6 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:70771-1203-1 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:70771-1203-5 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:70771-1203-0 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
5 NDC:70771-1203-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1203-2)
5 NDC:70771-1203-2 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (70771-1203-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202711 02/08/2018
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS (70771-1203), MANUFACTURE (70771-1203)

Revised: 08/2020 Cadila Healthcare Limited

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.