Phytonadione

PHYTONADIONE — phytonadione tablet
Cadila Healthcare Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Phytonadione Tablets USP, 5 mg

100 tablets

NDC 70771-1318-1

Rx only

label
(click image for full-size original)
PHYTONADIONE
phytonadione tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1318
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHYTONADIONE (PHYTONADIONE) PHYTONADIONE 5 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE (110000 WAMW)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SILICON DIOXIDE
Product Characteristics
Color YELLOW (LIGHT YELLOW TO YELLOW) Score 2 pieces
Shape ROUND (ROUND) Size 7mm
Flavor Imprint Code 1014
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1318-1 1 BOTTLE in 1 CARTON contains a BOTTLE
1 100 TABLET in 1 BOTTLE This package is contained within the CARTON (70771-1318-1)
2 NDC:70771-1318-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1318-2)
2 NDC:70771-1318-2 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (70771-1318-4)
3 NDC:70771-1318-3 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210189 02/22/2019
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (863362789)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 863362789 ANALYSIS (70771-1318), MANUFACTURE (70771-1318)

Revised: 11/2021 Cadila Healthcare Limited

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