Ibuprofen (Page 5 of 5)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

400 mg label
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

600 mg label
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

800 mg label
(click image for full-size original)
IBUPROFEN ibuprofen tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64380-809
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 400 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
MAGNESIUM STEARATE
HYPROMELLOSES
SODIUM CITRATE
LACTOSE MONOHYDRATE
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 13mm
Flavor Imprint Code IBU;400
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64380-809-06 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:64380-809-07 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078329 08/24/2018
IBUPROFEN ibuprofen tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64380-808
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 600 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
MAGNESIUM STEARATE
HYPROMELLOSES
SODIUM CITRATE
LACTOSE MONOHYDRATE
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 18mm
Flavor Imprint Code IBU;600
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64380-808-06 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:64380-808-07 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078329 08/24/2018
IBUPROFEN ibuprofen tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64380-807
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 800 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
MAGNESIUM STEARATE
HYPROMELLOSES
SODIUM CITRATE
LACTOSE MONOHYDRATE
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code IBU;800
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64380-807-07 500 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:64380-807-06 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078329 08/24/2018
Labeler — Strides Pharma Science Limited (650738743)
Establishment
Name Address ID/FEI Operations
Strides Pharma Science Limited 871402375 ANALYSIS (64380-807), ANALYSIS (64380-808), ANALYSIS (64380-809), MANUFACTURE (64380-807), MANUFACTURE (64380-808), MANUFACTURE (64380-809), PACK (64380-807), PACK (64380-808), PACK (64380-809)
Establishment
Name Address ID/FEI Operations
Strides Pharma Science Limited 918513263 ANALYSIS (64380-807), ANALYSIS (64380-808), ANALYSIS (64380-809), MANUFACTURE (64380-807), MANUFACTURE (64380-808), MANUFACTURE (64380-809), PACK (64380-807), PACK (64380-808), PACK (64380-809)
Establishment
Name Address ID/FEI Operations
Vivimed Life Sciences Private Limited 860477684 ANALYSIS (64380-807), ANALYSIS (64380-808), ANALYSIS (64380-809), MANUFACTURE (64380-807), MANUFACTURE (64380-808), MANUFACTURE (64380-809), PACK (64380-807), PACK (64380-808), PACK (64380-809)

Revised: 01/2020 Strides Pharma Science Limited

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