Ibuprofen tablet

Storage

Store at 20 to 25C (68 to 77F) [see USP Controlled Room Temperature]. Avoid excessive heat40C (104F). Dispense in a tight, light-resistant container as defined in the USP.

Ingredients and appearance - Product information

Ibuprofen tablet- Ibuprofen

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 50090-0056
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Ibuprofen ( UNII: WK2XYI10QM)( Ibuprofen - UNII: WK2XYI10QM ) 400 mgin 1

Product Characteristics

Color WHITE Imprint Code IP;464
Score 1 Shape ROUND (Biconvex)
Size 13 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 50090-0056-0 16 in 1 BOTTLE 2014/11/28
2 NDC: 50090-0056-1 30 in 1 BOTTLE 2014/11/28
3 NDC: 50090-0056-3 100 in 1 BOTTLE 2014/11/28
4 NDC: 50090-0056-4 20 in 1 BOTTLE 2014/11/28
5 NDC: 50090-0056-6 21 in 1 BOTTLE 2014/11/28
6 NDC: 50090-0056-8 60 in 1 BOTTLE 2014/11/28
7 NDC: 50090-0056-5 40 in 1 BOTTLE 2014/01/27
8 NDC: 50090-0056-2 50 in 1 BOTTLE 2014/07/28

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA078558 USA 2014/07/28

Ibuprofen tablet- Ibuprofen

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 50090-0058
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Ibuprofen ( UNII: WK2XYI10QM)( Ibuprofen - UNII: WK2XYI10QM ) 600 mgin 1

Product Characteristics

Color WHITE Imprint Code IP;465
Score 1 Shape OVAL (Biconvex)
Size 17 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 50090-0058-0 10 in 1 BOTTLE 2014/11/28
2 NDC: 50090-0058-1 12 in 1 BOTTLE 2014/11/28
3 NDC: 50090-0058-2 16 in 1 BOTTLE 2014/11/28
4 NDC: 50090-0058-3 30 in 1 BOTTLE 2014/11/28
5 NDC: 50090-0058-4 60 in 1 BOTTLE 2014/11/28
6 NDC: 50090-0058-5 100 in 1 BOTTLE 2014/11/28
7 NDC: 50090-0058-7 40 in 1 BOTTLE 2014/11/28
8 NDC: 50090-0058-8 20 in 1 BOTTLE 2014/11/28
9 NDC: 50090-0058-9 24 in 1 BOTTLE 2014/11/28

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA078558 USA 2014/11/28

Ibuprofen tablet- Ibuprofen

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 50090-0064
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Ibuprofen ( UNII: WK2XYI10QM)( Ibuprofen - UNII: WK2XYI10QM ) 800 mgin 1

Product Characteristics

Color WHITE Imprint Code IP;466
Score 1 Shape OVAL (Biconvex)
Size 19 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 50090-0064-0 10 in 1 BOTTLE 2014/11/28
2 NDC: 50090-0064-1 15 in 1 BOTTLE 2014/11/28
3 NDC: 50090-0064-2 30 in 1 BOTTLE 2014/11/28
4 NDC: 50090-0064-3 45 in 1 BOTTLE 2014/11/28
5 NDC: 50090-0064-4 60 in 1 BOTTLE 2014/11/28
6 NDC: 50090-0064-5 100 in 1 BOTTLE 2014/11/28
7 NDC: 50090-0064-6 50 in 1 BOTTLE 2014/11/28
8 NDC: 50090-0064-7 21 in 1 BOTTLE 2014/11/28
9 NDC: 50090-0064-8 12 in 1 BOTTLE 2014/11/28
10 NDC: 50090-0064-9 40 in 1 BOTTLE 2014/11/28

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA078558 USA 2014/11/28

Labeler - A-S Medication Solutions( 830016429)

Establishment

Name ID/FEI Business Operations
A-S Medication Solutions 830016429 RELABEL( 50090-0056, 50090-0058, 50090-0064), REPACK( 50090-0056, 50090-0058, 50090-0064)

Ibuprofen

Ibuprofen

Ibuprofen