Prescription Drug Information: Ibuprofen (Page 5 of 5)

Package/Label Display Panel

NDC 70436-180-01

Ibuprofen Tablets, USP, 400 mg

Rx only

100 Tablets

400mg-100ct
(click image for full-size original)

Package/Label Display Panel

NDC 70436-180-02

Ibuprofen Tablets, USP, 400 mg

Rx only

500 Tablets

400mg-500ct
(click image for full-size original)

Package/Label Display Panel

NDC 70436-181-01

Ibuprofen Tablets, USP, 600 mg

Rx only

100 Tablets

600mg-100ct
(click image for full-size original)

Package/Label Display Panel

NDC 70436-181-02

Ibuprofen Tablets, USP, 600 mg

Rx only

500 Tablets

600mg-500ct
(click image for full-size original)

Package/Label Display Panel

NDC 70436-182-01

Ibuprofen Tablets, USP, 800 mg

Rx only

100 Tablets

800mg-100ct
(click image for full-size original)

Package/Label Display Panel

NDC 70436-182-02

Ibuprofen Tablets, USP, 800 mg

Rx only

500 Tablets

800mg-500ct
(click image for full-size original)
IBUPROFEN ibuprofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70436-180
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
CROSCARMELLOSE SODIUM
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
TALC
Product Characteristics
Color white (white to off-white) Score no score
Shape OVAL Size 14mm
Flavor Imprint Code 157
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70436-180-01 100 TABLET in 1 BOTTLE None
2 NDC:70436-180-02 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215318 07/25/2022
IBUPROFEN ibuprofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70436-181
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
CROSCARMELLOSE SODIUM
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
TALC
Product Characteristics
Color white (white to off-white) Score no score
Shape CAPSULE Size 17mm
Flavor Imprint Code 152
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70436-181-01 100 TABLET in 1 BOTTLE None
2 NDC:70436-181-02 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215318 07/25/2022
IBUPROFEN ibuprofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70436-182
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
CROSCARMELLOSE SODIUM
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
TALC
Product Characteristics
Color white (white to off-white) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code 151
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70436-182-01 100 TABLET in 1 BOTTLE None
2 NDC:70436-182-02 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215318 07/25/2022
Labeler — Slate Run Pharmaceuticals, LLC (039452765)
Registrant — Yichang Humanwell Pharmaceutical Co,. Ltd. (527225336)
Establishment
Name Address ID/FEI Operations
Yichang Humanwell Oral Solid Dosge Plant 421371958 manufacture (70436-180), manufacture (70436-181), manufacture (70436-182)

Revised: 11/2022 Slate Run Pharmaceuticals, LLC

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