Larin Fe 1/20 (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

13
(click image for full-size original)
LARIN FE 1/20
norethindrone acetate/ethinyl estradiol and ferrous fumarate kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-406
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-406-01 1 BLISTER PACK in 1 PACKET contains a BLISTER PACK
1 1 KIT in 1 BLISTER PACK This package is contained within the PACKET (16714-406-01)
2 NDC:16714-406-02 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 1 KIT in 1 BLISTER PACK This package is contained within the CARTON (16714-406-02)
3 NDC:16714-406-03 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 1 KIT in 1 BLISTER PACK This package is contained within the CARTON (16714-406-03)
4 NDC:16714-406-04 6 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 1 KIT in 1 BLISTER PACK This package is contained within the CARTON (16714-406-04)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 21
Part 2 7
Part 1 of 2
NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE
norethindrone acetate and ethinyl estradiol tablet
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NORETHINDRONE ACETATE (NORETHINDRONE) NORETHINDRONE ACETATE 1 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 20 ug
Inactive Ingredients
Ingredient Name Strength
POLYVINYL ALCOHOL
TITANIUM DIOXIDE
TALC
POLYETHYLENE GLYCOL 3350
LECITHIN, SOYBEAN
D&C YELLOW NO. 10
FD&C BLUE NO. 2
FD&C YELLOW NO. 6
LACTOSE
MAGNESIUM STEARATE
STARCH, PREGELATINIZED CORN
Product Characteristics
Color YELLOW (pale) Score no score
Shape ROUND Size 5mm
Flavor Imprint Code L2
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091454 08/26/2013
Part 2 of 2
INERT
placebo tablet
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
FERROUS FUMARATE 75 mg
POLYVINYL ALCOHOL
TALC
POLYETHYLENE GLYCOL 3350
LECITHIN, SOYBEAN
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
CELLULOSE, MICROCRYSTALLINE
HYDROXYPROPYL CELLULOSE
MAGNESIUM STEARATE
CROSPOVIDONE
Product Characteristics
Color BROWN Score no score
Shape ROUND Size 5mm
Flavor Imprint Code F;N
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091454 08/26/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091454 08/26/2013
Labeler — Northstar Rx LLC (830546433)
Registrant — Novast Laboratories, Ltd. (527695995)
Establishment
Name Address ID/FEI Operations
Novast Laboratories, Ltd. 527695995 analysis (16714-406), label (16714-406), manufacture (16714-406), pack (16714-406)

Revised: 04/2019 Northstar Rx LLC

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 © 2022. All Rights Reserved.