NDC Code(s) : 0074-3224-14, 0074-3224-56, 0074-3271-14, 0074-3271-56, 0074-3197-16, 0074-3197-30, 0074-3282-14, 0074-3282-56, 0074-3239-14, 0074-3239-56
Packager : AbbVie Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ModeribaRibavirin KIT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0074-3224
Route of Administration DEA Schedule
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0074-3224-564 in 1 KIT 20/01/2014
1NDC:0074-3224-141 in 1 DOSE PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077456 01/20/2014
ModeribaRibavirin KIT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0074-3271
Route of Administration DEA Schedule
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0074-3271-564 in 1 KIT 20/01/2014
1NDC:0074-3271-141 in 1 DOSE PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077456 01/20/2014
ModeribaRibavirin TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0074-3197
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RIBAVIRIN(UNII: 49717AWG6K)
(RIBAVIRIN - UNII:49717AWG6K) 		RIBAVIRIN200 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
POVIDONES(UNII: FZ989GH94E)
MAGNESIUM STEARATE(UNII: 70097M6I30)
WATER(UNII: 059QF0KO0R)
POLYVINYL ALCOHOL(UNII: 532B59J990)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
TALC(UNII: 7SEV7J4R1U)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
CARNAUBA WAX(UNII: R12CBM0EIZ)
Product Characteristics
Color BLUE (light) Score no score
Shape OVAL Size 12 mm
Flavor Imprint Code 200;3RP
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0074-3197-16168 in 1 BOTTLE Type 0: Not a Combination Product20/01/2014
2NDC:0074-3197-30168 in 1 BOTTLE Type 0: Not a Combination Product20/01/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077456 01/20/2014
ModeribaRibavirin TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0074-3282
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RIBAVIRIN(UNII: 49717AWG6K)
(RIBAVIRIN - UNII:49717AWG6K) 		RIBAVIRIN600 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
POVIDONES(UNII: FZ989GH94E)
MAGNESIUM STEARATE(UNII: 70097M6I30)
WATER(UNII: 059QF0KO0R)
POLYVINYL ALCOHOL(UNII: 532B59J990)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
TALC(UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
CARNAUBA WAX(UNII: R12CBM0EIZ)
Product Characteristics
Color BLUE (dark) Score no score
Shape OVAL Size 19 mm
Flavor Imprint Code 600;3RP
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0074-3282-564 in 1 CARTON 20/01/2014
1NDC:0074-3282-1414 in 1 DOSE PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077456 01/20/2014
ModeribaRibavirin TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0074-3239
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RIBAVIRIN(UNII: 49717AWG6K)
(RIBAVIRIN - UNII:49717AWG6K) 		RIBAVIRIN400 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
POVIDONES(UNII: FZ989GH94E)
MAGNESIUM STEARATE(UNII: 70097M6I30)
WATER(UNII: 059QF0KO0R)
POLYVINYL ALCOHOL(UNII: 532B59J990)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
TALC(UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
CARNAUBA WAX(UNII: R12CBM0EIZ)
Product Characteristics
Color BLUE (medium) Score no score
Shape OVAL Size 18 mm
Flavor Imprint Code 400;3RP
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0074-3239-564 in 1 CARTON 20/01/2014
1NDC:0074-3239-1414 in 1 DOSE PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077456 01/20/2014

PRINCIPAL DISPLAY PANEL

NDC 0074-3197-16

Moderiba™

(ribavirin, USP) Tablets

200 mg

168 Tablets

AVOID PREGNANCY WHILE TAKING THIS MEDICATION. READ THE MEDICATION GUIDE FOR IMPORTANT INFORMATION.

Rx only abbvie

moderiba 200mg tablets

NDC 0074-3224-14

Moderiba™ 600 Dose Pack

(ribavirin, USP) Tablets

200 mg / 400 mg

AVOID PREGNANCY WHILE TAKING THIS MEDICATION. READ THE MEDICATION GUIDE FOR IMPORTANT INFORMATION.

Contains 7 ribavirin tablets (200 mg each) and 7 ribavirin tablets (400 mg each)

AM Dose: 200 mg / PM Dose: 400 mg

Patient instructions for each daily dose:

AM – In the morning, push one ribavirin tablet, 200 mg through the cardboard backing.

PM – In the evening, push one ribavirin tablet, 400 mg through the cardboard backing.

Please read the enclosed Medication Guide

Rx only abbvie

moderiba 200mg tablets

NDC 0074-3224-56

Moderiba™ 600 Dose Pack

(ribavirin, USP) Tablets

200 mg / 400 mg

56 Tablets in 4 Unit Dose Packs

Each Unit Dose Pack contains

7 ribavirin tablets (200 mg each) and

7 ribavirin tablets (400 mg each)

AVOID PREGNANCY WHILE TAKING THIS MEDICATION. READ THE MEDICATION GUIDE FOR IMPORTANT INFORMATION.

moderiba 200mg tablets

NDC 0074-3239-14

Moderiba™ 800 Dose Pack

(ribavirin, USP) Tablets

400 mg / 400 mg

AVOID PREGNANCY WHILE TAKING THIS MEDICATION. READ THE MEDICATION GUIDE FOR IMPORTANT INFORMATION.

Contains 14 ribavirin tablets (400 mg each)

AM Dose: 400 mg / PM Dose: 400 mg

Patient instructions for each daily dose:

AM – In the morning, push one ribavirin tablet, 400 mg through the cardboard backing.

PM – In the evening, push one ribavirin tablet, 400 mg through the cardboard backing.

Please read the enclosed Medication Guide

Rx only abbvie

moderiba 200mg tablets

NDC 0074-3239-56

Moderiba™ 800 Dose Pack

(ribavirin, USP) Tablets

400 mg / 400 mg

56 Tablets in 4 Unit Dose Packs

Each Unit Dose Pack contains

14 ribavirin tablets (400 mg each)

AVOID PREGNANCY WHILE TAKING THIS MEDICATION. READ THE MEDICATION GUIDE FOR IMPORTANT INFORMATION.

moderiba 200mg tablets

NDC 0074-3271-14

Moderiba™ 1000 Dose Pack

(ribavirin, USP) Tablets

600 mg / 400 mg

AVOID PREGNANCY WHILE TAKING THIS MEDICATION. READ THE MEDICATION GUIDE FOR IMPORTANT INFORMATION.

Contains 7 ribavirin tablets (600 mg each) and 7 ribavirin tablets (400 mg each)

AM Dose: 600 mg / PM Dose: 400 mg

Patient instructions for each daily dose:

AM - In the morning, push one ribavirin tablet, 600 mg through the cardboard backing.

PM - In the evening, push one ribavirin tablet, 400 mg through the cardboard backing.

Please read the enclosed Medication Guide

Rx only abbvie

moderiba 200mg tablets

NDC 0074-3271-56

Moderiba™ 1000 Dose Pack

(ribavirin, USP) Tablets

600 mg / 400 mg

56 Tablets in 4 Unit Dose Packs

Each Unit Dose Pack contains

7 ribavirin tablets (600 mg each) and

7 ribavirin tablets (400 mg each)

AVOID PREGNANCY WHILE TAKING THIS MEDICATION. READ THE MEDICATION GUIDE FOR IMPORTANT INFORMATION.

moderiba 200mg tablets

NDC 0074-3282-14

Moderiba™ 1200 Dose Pack

(ribavirin, USP) Tablets

600 mg / 600 mg

AVOID PREGNANCY WHILE TAKING THIS MEDICATION. READ THE MEDICATION GUIDE FOR IMPORTANT INFORMATION.

Contains 14 ribavirin tablets (600 mg each)

AM Dose: 600 mg / PM Dose: 600 mg

Patient instructions for each daily dose:

AM - In the morning, push one ribavirin tablet, 600 mg through the cardboard backing.

PM - In the evening, push one ribavirin tablet, 600 mg through the cardboard backing.

Please read the enclosed Medication Guide

Rx only abbvie

moderiba 200mg tablets

NDC 0074-3282-56

Moderiba™ 1200 Dose Pack

(ribavirin, USP) Tablets

600 mg / 600 mg

56 Tablets in 4 Unit Dose Packs

Each Unit Dose Pack contains

14 ribavirin tablets (600 mg each)

AVOID PREGNANCY WHILE TAKING THIS MEDICATION. READ THE MEDICATION GUIDE FOR IMPORTANT INFORMATION.

moderiba 200mg tablets