Prescription Drug Information: Ibuprofen (Page 4 of 4)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 76282-712-10 Rx only

IBUPROFEN TABLETS, USP 400 mg

PHARMACIST: DISPENSE THE MEDICATION GUIDE PROVIDED SEPARATELY TO EACH PATIENT

Exelan Pharmaceuticals

100 Tablets

image description
(click image for full-size original)

NDC 76282-712-50 Rx only

IBUPROFEN TABLETS, USP 400 mg

PHARMACIST: DISPENSE THE MEDICATION GUIDE PROVIDED SEPARATELY TO EACH PATIENT

Exelan Pharmaceuticals

500 Tablets

image description
(click image for full-size original)

NDC 76282-712-55 Rx only

IBUPROFEN TABLETS, USP 400 mg

PHARMACIST: DISPENSE THE MEDICATION GUIDE PROVIDED SEPARATELY TO EACH PATIENT

Exelan Pharmaceuticals

1000 Tablets

image description
(click image for full-size original)

NDC 76282-713-10 Rx only

IBUPROFEN TABLETS, USP 600 mg

PHARMACIST: DISPENSE THE MEDICATION GUIDE PROVIDED SEPARATELY TO EACH PATIENT

Exelan Pharmaceuticals

100 Tablets

image description
(click image for full-size original)

NDC 76282-713-50 Rx only

IBUPROFEN TABLETS, USP 600 mg

PHARMACIST: DISPENSE THE MEDICATION GUIDE PROVIDED SEPARATELY TO EACH PATIENT

Exelan Pharmaceuticals

500 Tablets

image description
(click image for full-size original)

NDC 76282-713-55 Rx only

IBUPROFEN TABLETS, USP 600 mg

PHARMACIST: DISPENSE THE MEDICATION GUIDE PROVIDED SEPARATELY TO EACH PATIENT

Exelan Pharmaceuticals

1000 Tablets

image description
(click image for full-size original)

NDC 76282-714-10 Rx only

IBUPROFEN TABLETS, USP 800 mg

PHARMACIST: DISPENSE THE MEDICATION GUIDE PROVIDED SEPARATELY TO EACH PATIENT

Exelan Pharmaceuticals

100 Tablets

image description
(click image for full-size original)

NDC 76282-714-50 Rx only

IBUPROFEN TABLETS, USP 800 mg

PHARMACIST: DISPENSE THE MEDICATION GUIDE PROVIDED SEPARATELY TO EACH PATIENT

Exelan Pharmaceuticals

500 Tablets

image description
(click image for full-size original)

NDC 76282-714-55 Rx only

IBUPROFEN TABLETS, USP 800 mg

PHARMACIST: DISPENSE THE MEDICATION GUIDE PROVIDED SEPARATELY TO EACH PATIENT

Exelan Pharmaceuticals

1000 Tablets

image description
(click image for full-size original)

NDC 76282-712-64 Rx only

IBUPROFEN TABLETS, USP 400 mg

Exelan Pharmaceuticals

10000 Tablets

ibuprofen-400mg-bulk-label-jpg.jpg
(click image for full-size original)

NDC 76282-713-64 Rx only

IBUPROFEN TABLETS, USP 600 mg

Exelan Pharmaceuticals

10000 Tablets

ibuprofen-600mg-bulk-label-jpg.jpg
(click image for full-size original)

NDC 76282-714-65 Rx only

IBUPROFEN TABLETS, USP 800 mg

Exelan Pharmaceuticals

11400 Tablets

ibuprofen-800mg-bulk-label-jpg.jpg
(click image for full-size original)

IBUPROFEN
ibuprofen tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76282-712
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
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE 2910 (5 MPA.S)
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSE 2910 (3 MPA.S)
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM LAURYL SULFATE
POVIDONE K90
TITANIUM DIOXIDE
WATER
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 400
STARCH, CORN
Product Characteristics
Color white (off-white) Score no score
Shape OVAL Size 14mm
Flavor Imprint Code I;6
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76282-712-10 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:76282-712-50 500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:76282-712-55 1000 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:76282-712-64 10000 TABLET, FILM COATED in 1 POUCH None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091625 03/10/2022
IBUPROFEN
ibuprofen tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76282-713
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
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE 2910 (5 MPA.S)
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSE 2910 (3 MPA.S)
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM LAURYL SULFATE
POVIDONE K90
TITANIUM DIOXIDE
WATER
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 400
STARCH, CORN
Product Characteristics
Color white (off-white) Score no score
Shape OVAL (caplet-shaped tablet) Size 17mm
Flavor Imprint Code I;7
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76282-713-10 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:76282-713-50 500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:76282-713-55 1000 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:76282-713-64 10000 TABLET, FILM COATED in 1 POUCH None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091625 03/10/2022
IBUPROFEN
ibuprofen tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76282-714
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
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE 2910 (5 MPA.S)
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSE 2910 (3 MPA.S)
CELLULOSE, MICROCRYSTALLINE
SODIUM LAURYL SULFATE
POVIDONE K90
TITANIUM DIOXIDE
WATER
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 400
STARCH, CORN
MAGNESIUM STEARATE
Product Characteristics
Color white (off-white) Score no score
Shape OVAL (caplet-shaped tablet) Size 19mm
Flavor Imprint Code I;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76282-714-10 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:76282-714-50 500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:76282-714-55 1000 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:76282-714-65 11400 TABLET, FILM COATED in 1 POUCH None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091625 03/10/2022
Labeler — EXELAN PHARMACEUTICALS, INC. (967795266)
Registrant — Granules India Limited (915000087)
Establishment
Name Address ID/FEI Operations
Granules India Limited 918609236 manufacture (76282-712), manufacture (76282-713), manufacture (76282-714)

Revised: 03/2022 EXELAN PHARMACEUTICALS, INC.

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