Ibuprofen (Page 7 of 7)

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IBUPROFEN ibuprofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53746-464
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 400 mg
Product Characteristics
Color white Score no score
Shape ROUND (Biconvex) Size 13mm
Flavor Imprint Code IP;464
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53746-464-30 30 TABLET in 1 BOTTLE None
2 NDC:53746-464-60 60 TABLET in 1 BOTTLE None
3 NDC:53746-464-90 90 TABLET in 1 BOTTLE None
4 NDC:53746-464-01 100 TABLET in 1 BOTTLE None
5 NDC:53746-464-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078558 11/23/2009
IBUPROFEN ibuprofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53746-465
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 600 mg
Product Characteristics
Color white Score no score
Shape OVAL (Biconvex) Size 17mm
Flavor Imprint Code IP;465
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53746-465-50 50 TABLET in 1 BOTTLE None
2 NDC:53746-465-60 60 TABLET in 1 BOTTLE None
3 NDC:53746-465-90 90 TABLET in 1 BOTTLE None
4 NDC:53746-465-01 100 TABLET in 1 BOTTLE None
5 NDC:53746-465-05 500 TABLET in 1 BOTTLE None
6 NDC:53746-465-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078558 11/23/2009
IBUPROFEN ibuprofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53746-466
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 800 mg
Product Characteristics
Color white Score no score
Shape OVAL (Biconvex) Size 19mm
Flavor Imprint Code IP;466
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53746-466-30 30 TABLET in 1 BOTTLE None
2 NDC:53746-466-60 60 TABLET in 1 BOTTLE None
3 NDC:53746-466-50 50 TABLET in 1 BOTTLE None
4 NDC:53746-466-90 90 TABLET in 1 BOTTLE None
5 NDC:53746-466-01 100 TABLET in 1 BOTTLE None
6 NDC:53746-466-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078558 11/23/2009
Labeler — Amneal Pharmaceuticals of New York LLC (123797875)
Establishment
Name Address ID/FEI Operations
Amneal Pharmaceuticals, LLC 969951594 pack (53746-464), pack (53746-465), pack (53746-466), repack (53746-464), repack (53746-465), repack (53746-466)

Revised: 12/2021 Amneal Pharmaceuticals of New York LLC

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