Fyavolv (Page 10 of 10)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fyavolv™ (norethindrone and ethinyl estradiol tablets USP)

0.5 mg/0.0025 mg

Rx Only

Wallet and Pouch Label: 28 Tablets — NDC 68180-827-11

Carton Label: 3 Wallets of 28 Tablets Each — NDC 68180-827-13

Fyavolv (norethindrone and ethinyl estradiol tablets USP) 
0.5 mg/0.0025 mg
Rx Only
NDC 68180-827-13
Wallet Label: 28 Tablets
(click image for full-size original)
Fyavolv (norethindrone and ethinyl estradiol tablets USP) 
0.5 mg/0.0025 mg
Rx Only
NDC 68180-827-13
Pouch Label: 1 Wallet of 28 Tablets
(click image for full-size original)
Fyavolv (norethindrone and ethinyl estradiol tablets USP) 
0.5 mg/0.0025 mg
Rx Only
NDC 68180-827-13
Carton Label: 3 Wallets of 28 Tablets Each
(click image for full-size original)

Fyavolv™ (norethindrone and ethinyl estradiol tablets USP)

0.5 mg/0.0025 mg

Rx Only

NDC 68180-827-09

Bottle Label: 90 Tablets

Bottle label
(click image for full-size original)

Fyavolv™ (norethindrone and ethinyl estradiol tablets USP)

1 mg/0.005 mg

Rx Only

Wallet and Pouch Label: 28 Tablets — NDC 68180-828-11

Carton Label: 3 Wallets of 28 Tablets Each — NDC 68180-828-13

Fyavolv (norethindrone and ethinyl estradiol tablets USP) 
1 mg/0.005 mg
Rx Only
NDC 68180-828-13
Wallet Label: 28 Tablets
(click image for full-size original)
Fyavolv (norethindrone and ethinyl estradiol tablets USP) 
1 mg/0.005 mg
Rx Only
NDC 68180-828-13
Pouch Label: 1 Wallet of 28 Tablets
(click image for full-size original)
Fyavolv (norethindrone and ethinyl estradiol tablets USP) 
1 mg/0.005 mg
Rx Only
NDC 68180-828-13
Carton Label: 3 Wallets of 28 Tablets Each
(click image for full-size original)

Fyavolv™ (norethindrone and ethinyl estradiol tablets USP)

1 mg/0.005 mg

Rx Only

NDC 68180-828-09

Bottle Label: 90 Tablets

Bottle label
(click image for full-size original)

Fyavolv™ (norethindrone and ethinyl estradiol tablets USP)

0.5 mg/0.0025 mg

Rx Only

Blister and Pouch Label: 28 Tablets — NDC 68180-827-71

Carton Label: 3 Blister of 28 Tablets Each — NDC 68180-827-73

Blister Label: 28 Tablets -- NDC 68180-827-71
(click image for full-size original)
Pouch Label: 28 Tablets -- NDC 68180-827-71
(click image for full-size original)
Carton Label: 3 Blister of 28 Tablets Each -- NDC 68180-827-73
(click image for full-size original)

Fyavolv™ (norethindrone and ethinyl estradiol tablets USP)

1 mg/0.005 mg

Rx Only

Blister and Pouch Label: 28 Tablets — NDC 68180-828-71

Carton Label: 3 Blister of 28 Tablets Each — NDC 68180-828-73

Blister Label: 28 Tablets -- NDC 68180-828-71
(click image for full-size original)
Pouch Label: 28 Tablets -- NDC 68180-828-71
(click image for full-size original)
Carton Label: 3 Blister of 28 Tablets Each -- NDC 68180-828-73
(click image for full-size original)
FYAVOLV norethindrone acetate and ethinyl estradiol tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-827
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.0025 mg
NORETHINDRONE ACETATE (NORETHINDRONE) NORETHINDRONE ACETATE 0.5 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
HYPROMELLOSES
LACTOSE MONOHYDRATE
POLYETHYLENE GLYCOL 400
STARCH, CORN
TITANIUM DIOXIDE
TOCOPHEROL
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND (round) Size 6mm
Flavor Imprint Code LU;F51
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68180-827-73 3 POUCH in 1 CARTON contains a POUCH (68180-827-71)
1 NDC:68180-827-71 1 BLISTER PACK in 1 POUCH This package is contained within the CARTON (68180-827-73) and contains a BLISTER PACK
1 28 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within a POUCH (68180-827-71) and a CARTON (68180-827-73)
2 NDC:68180-827-13 3 POUCH in 1 CARTON contains a POUCH (68180-827-11)
2 NDC:68180-827-11 1 BLISTER PACK in 1 POUCH This package is contained within the CARTON (68180-827-13) and contains a BLISTER PACK
2 28 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within a POUCH (68180-827-11) and a CARTON (68180-827-13)
3 NDC:68180-827-09 1 BOTTLE in 1 CARTON contains a BOTTLE
3 90 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (68180-827-09)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204213 03/15/2016
FYAVOLV norethindrone acetate and ethinyl estradiol tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-828
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.005 mg
NORETHINDRONE ACETATE (NORETHINDRONE) NORETHINDRONE ACETATE 1 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
FD&C BLUE NO. 2
HYPROMELLOSES
LACTOSE MONOHYDRATE
POLYETHYLENE GLYCOL 400
STARCH, CORN
TITANIUM DIOXIDE
TOCOPHEROL
Product Characteristics
Color BLUE (Blue) Score no score
Shape ROUND (round) Size 6mm
Flavor Imprint Code LU;F52
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68180-828-73 3 POUCH in 1 CARTON contains a POUCH (68180-828-71)
1 NDC:68180-828-71 1 BLISTER PACK in 1 POUCH This package is contained within the CARTON (68180-828-73) and contains a BLISTER PACK
1 28 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within a POUCH (68180-828-71) and a CARTON (68180-828-73)
2 NDC:68180-828-13 3 POUCH in 1 CARTON contains a POUCH (68180-828-11)
2 NDC:68180-828-11 1 BLISTER PACK in 1 POUCH This package is contained within the CARTON (68180-828-13) and contains a BLISTER PACK
2 28 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within a POUCH (68180-828-11) and a CARTON (68180-828-13)
3 NDC:68180-828-09 1 BOTTLE in 1 CARTON contains a BOTTLE
3 90 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (68180-828-09)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204213 03/15/2016
Labeler — Lupin Pharmaceuticals, Inc. (089153071)
Registrant — LUPIN LIMITED (675923163)
Establishment
Name Address ID/FEI Operations
LUPIN LIMITED 650582310 MANUFACTURE (68180-827), MANUFACTURE (68180-828)

Revised: 08/2021 Lupin Pharmaceuticals, Inc.

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