Warfarin sodium tablet

Storage

Protect from light and moisture. Store at 20 to 25C (68 to 77F); excursions permitted between 15 to 30C (59 to 86F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.

Ingredients and appearance - Product information

Warfarin sodium tablet- Warfarin

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 50090-2582
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Warfarin sodium ( UNII: 6153CWM0CL)( Warfarin - UNII: 5Q7ZVV76EI ) 7.5 mgin 1

Inactive Ingredients

Ingredient Name Code
Hydroxypropyl cellulose (70000 wamw) ( UNII: 66O7AQV0RT)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Starch, corn ( UNII: O8232NY3SJ)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)
D&c yellow no. 10 ( UNII: 35SW5USQ3G)

Product Characteristics

Color YELLOW (Light) Imprint Code 768;7;1;2;AN
Score 2 Shape OVAL
Size 11 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 50090-2582-0 30 in 1 BOTTLE 2016/11/01
2 NDC: 50090-2582-1 90 in 1 BOTTLE 2017/01/11

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA202202 USA 2017/01/11

Warfarin sodium tablet- Warfarin

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 50090-2586
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Warfarin sodium ( UNII: 6153CWM0CL)( Warfarin - UNII: 5Q7ZVV76EI ) 2.5 mgin 1

Inactive Ingredients

Ingredient Name Code
Hydroxypropyl cellulose (70000 wamw) ( UNII: 66O7AQV0RT)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Starch, corn ( UNII: O8232NY3SJ)
D&c yellow no. 10 ( UNII: 35SW5USQ3G)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)

Product Characteristics

Color GREEN (light) Imprint Code 763;2;1;2;AN
Score 2 Shape OVAL
Size 11 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 50090-2586-0 30 in 1 BOTTLE 2016/11/02
2 NDC: 50090-2586-1 90 in 1 BOTTLE 2017/01/04

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA202202 USA 2017/01/04

Warfarin sodium tablet- Warfarin

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 50090-2613
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Warfarin sodium ( UNII: 6153CWM0CL)( Warfarin - UNII: 5Q7ZVV76EI ) 3 mgin 1

Inactive Ingredients

Ingredient Name Code
Hydroxypropyl cellulose (70000 wamw) ( UNII: 66O7AQV0RT)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Starch, corn ( UNII: O8232NY3SJ)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)
Fd&c blue no. 2 ( UNII: L06K8R7DQK)
Fd&c red no. 40 ( UNII: WZB9127XOA)

Product Characteristics

Color BROWN (light tan) Imprint Code 764;3;AN
Score 2 Shape OVAL
Size 11 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 50090-2613-0 30 in 1 BOTTLE 2016/11/10

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA202202 USA 2016/11/10

Warfarin sodium tablet- Warfarin

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 50090-2617
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Warfarin sodium ( UNII: 6153CWM0CL)( Warfarin - UNII: 5Q7ZVV76EI ) 6 mgin 1

Inactive Ingredients

Ingredient Name Code
Hydroxypropyl cellulose (70000 wamw) ( UNII: 66O7AQV0RT)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Starch, corn ( UNII: O8232NY3SJ)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)

Product Characteristics

Color TURQUOISE (light teal) Imprint Code 767;6;AN
Score 2 Shape OVAL
Size 11 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 50090-2617-0 30 in 1 BOTTLE 2016/11/14

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA202202 USA 2016/11/14

Warfarin sodium tablet- Warfarin

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 50090-2645
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Warfarin sodium ( UNII: 6153CWM0CL)( Warfarin - UNII: 5Q7ZVV76EI ) 4 mgin 1

Inactive Ingredients

Ingredient Name Code
Hydroxypropyl cellulose (70000 wamw) ( UNII: 66O7AQV0RT)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Starch, corn ( UNII: O8232NY3SJ)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)

Product Characteristics

Color BLUE (Light) Imprint Code 765;4;AN
Score 2 Shape OVAL
Size 11 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 50090-2645-0 30 in 1 BOTTLE 2016/11/23

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA202202 USA 2016/11/23

Warfarin sodium tablet- Warfarin

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 50090-2646
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Warfarin sodium ( UNII: 6153CWM0CL)( Warfarin - UNII: 5Q7ZVV76EI ) 1 mgin 1

Inactive Ingredients

Ingredient Name Code
Hydroxypropyl cellulose (70000 wamw) ( UNII: 66O7AQV0RT)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Starch, corn ( UNII: O8232NY3SJ)
D&c red no. 6 ( UNII: 481744AI4O)

Product Characteristics

Color PINK (light) Imprint Code 761;1;AN
Score 2 Shape OVAL
Size 11 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 50090-2646-0 30 in 1 BOTTLE 2016/11/23
2 NDC: 50090-2646-1 100 in 1 BOTTLE 2017/08/15

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA202202 USA 2017/08/15

Warfarin sodium tablet- Warfarin

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 50090-2654
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Warfarin sodium ( UNII: 6153CWM0CL)( Warfarin - UNII: 5Q7ZVV76EI ) 2 mgin 1

Inactive Ingredients

Ingredient Name Code
Hydroxypropyl cellulose (70000 wamw) ( UNII: 66O7AQV0RT)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Starch, corn ( UNII: O8232NY3SJ)
Fd&c blue no. 2 ( UNII: L06K8R7DQK)
Fd&c red no. 40 ( UNII: WZB9127XOA)

Product Characteristics

Color PURPLE (Light Lavender) Imprint Code 762;2;AN
Score 2 Shape OVAL
Size 11 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 50090-2654-0 30 in 1 BOTTLE 2016/11/29

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA202202 USA 2016/11/29

Warfarin sodium tablet- Warfarin

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 50090-2936
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Warfarin sodium ( UNII: 6153CWM0CL)( Warfarin - UNII: 5Q7ZVV76EI ) 5 mgin 1

Inactive Ingredients

Ingredient Name Code
Hydroxypropyl cellulose (70000 wamw) ( UNII: 66O7AQV0RT)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Starch, corn ( UNII: O8232NY3SJ)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)

Product Characteristics

Color ORANGE (Light peach) Imprint Code 766;5;AN
Score 2 Shape OVAL
Size 11 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 50090-2936-0 30 in 1 BOTTLE 2017/03/28
2 NDC: 50090-2936-1 60 in 1 BOTTLE 2017/03/31
3 NDC: 50090-2936-2 90 in 1 BOTTLE 2017/04/26

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA202202 USA 2017/04/26

Warfarin sodium tablet- Warfarin

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 50090-3263
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Warfarin sodium ( UNII: 6153CWM0CL)( Warfarin - UNII: 5Q7ZVV76EI ) 10 mgin 1

Inactive Ingredients

Ingredient Name Code
Hydroxypropyl cellulose (70000 wamw) ( UNII: 66O7AQV0RT)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Starch, corn ( UNII: O8232NY3SJ)

Product Characteristics

Color WHITE Imprint Code 769;10;AN
Score 2 Shape OVAL
Size 11 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 50090-3263-0 30 in 1 BOTTLE 2017/11/14

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA202202 USA 2017/11/14

Labeler - A-S Medication Solutions( 830016429)

Establishment

Name ID/FEI Business Operations
A-S Medication Solutions 830016429 RELABEL( 50090-2936, 50090-2582, 50090-2586, 50090-2613, 50090-2617, 50090-2645, 50090-2646, 50090-2654, 50090-3263), REPACK( 50090-2582, 50090-2586, 50090-2613, 50090-2617, 50090-2645, 50090-2646, 50090-2654, 50090-2936, 50090-3263)

Warfarin

Warfarin

Warfarin

Warfarin

Warfarin

Warfarin

Warfarin

Warfarin

Warfarin