Phytonadione (Page 2 of 2)

HOW SUPPLIED

Phytonadione tablets USP, 5 mg are supplied as light yellow to yellow colored, round, scored tablets, debossed with “AA” and “05” on either side of scoring and plain on the other side.
They are available as follows:

Bottle of 30 Tablets: NDC 69238-1051-3
Bottle of 100 Tablets: NDC 69238-1051-1

Storage:

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Always protect phytonadione tablets, USP from light. Store in tightly closed original container and carton until contents have been used (see PRECAUTIONS, General).

Manufactured by:
Amneal Pharmaceuticals Pvt. Ltd.
Oral Solid Dosage Unit

Ahmedabad 382213, INDIA

Distributed by:
Amneal Pharmaceuticals LLC

Bridgewater, NJ 08807

Rev. 10-2017-00

PRINCIPAL DISPLAY PANEL

NDC 69238-1051-3

Phytonadione Tablets USP, 5 mg

Rx Only

30 Tablets

Amneal Pharmaceuticals LLC

1
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1
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PHYTONADIONE
phytonadione tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1051
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
ACACIELLA ANGUSTISSIMA BARK
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SILICON DIOXIDE
STARCH, CORN
TALC
Product Characteristics
Color YELLOW (Light yellow to yellow) Score 2 pieces
Shape ROUND Size 6mm
Flavor Imprint Code AA;05
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69238-1051-3 1 BOTTLE in 1 CARTON contains a BOTTLE
1 30 TABLET in 1 BOTTLE This package is contained within the CARTON (69238-1051-3)
2 NDC:69238-1051-1 1 BOTTLE in 1 CARTON contains a BOTTLE
2 100 TABLET in 1 BOTTLE This package is contained within the CARTON (69238-1051-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209373 05/15/2018
Labeler — Amneal Pharmaceuticals NY LLC (123797875)
Establishment
Name Address ID/FEI Operations
Amneal Pharmaceuticals Private Limited Oral Solid Dosage Unit 650762060 MANUFACTURE (69238-1051), PACK (69238-1051)

Revised: 05/2019 Amneal Pharmaceuticals NY LLC

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