Celecoxib (Page 9 of 9)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-50 mg

Celecoxib Capsules 50 mg (30 Capsules in 1 bottle)
Each capsule contains 50 mg celecoxib, USP.46708-267-30

50 mg 30 Capsules in Bottle Pack
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-100 mg

Celecoxib Capsules 100 mg (30 Capsules in 1 bottle)

Each capsule contains 100 mg celecoxib, USP.

46708-268-30

100 mg 30 Capsules in Bottle Pack
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-200 mg

Celecoxib Capsule 200 mg (30 Capsules in 1 bottle)

Each capsules contains 200 mg celecoxib, USP.

46708-269-30

200 mg 30 Capsules in Bottle Pack
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-400 mg

Celecoxib Capsule 400 mg (30 Capsules in 1 bottle)

Each capsules contains 400 mg celecoxib, USP.

46708-270-30

400 mg 30 Capsules in Bottle Pack
(click image for full-size original)

CELECOXIB celecoxib capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-267
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CELECOXIB (CELECOXIB) CELECOXIB 50 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CROSCARMELLOSE SODIUM
POVIDONE K30
SODIUM LAURYL SULFATE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
GELATIN
SHELLAC
PROPYLENE GLYCOL
FERRIC OXIDE RED
Product Characteristics
Color WHITE (Opaque white) Score no score
Shape CAPSULE Size 11mm
Flavor Imprint Code A;134
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-267-30 30 CAPSULE in 1 BOTTLE None
2 NDC:46708-267-60 60 CAPSULE in 1 BOTTLE None
3 NDC:46708-267-91 1000 CAPSULE in 1 BOTTLE None
4 NDC:46708-267-12 80 CAPSULE in 1 CARTON None
5 NDC:46708-267-10 100 CAPSULE in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204519 08/22/2015
CELECOXIB celecoxib capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-268
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CELECOXIB (CELECOXIB) CELECOXIB 100 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CROSCARMELLOSE SODIUM
POVIDONE K30
SODIUM LAURYL SULFATE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
GELATIN
SHELLAC
PROPYLENE GLYCOL
FD&C BLUE NO. 2
Product Characteristics
Color WHITE (Opaque white) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code A;135
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-268-30 30 CAPSULE in 1 BOTTLE None
2 NDC:46708-268-31 100 CAPSULE in 1 BOTTLE None
3 NDC:46708-268-91 1000 CAPSULE in 1 BOTTLE None
4 NDC:46708-268-12 80 CAPSULE in 1 CARTON None
5 NDC:46708-268-10 100 CAPSULE in 1 CARTON None
6 NDC:46708-268-60 60 CAPSULE in 1 BOTTLE None
7 NDC:46708-268-71 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204519 08/22/2015
CELECOXIB celecoxib capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-269
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CELECOXIB (CELECOXIB) CELECOXIB 200 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CROSCARMELLOSE SODIUM
POVIDONE K30
SODIUM LAURYL SULFATE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
GELATIN
SHELLAC
PROPYLENE GLYCOL
FERRIC OXIDE YELLOW
Product Characteristics
Color WHITE (Opaque white) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code A;136
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-269-30 30 CAPSULE in 1 BOTTLE None
2 NDC:46708-269-31 100 CAPSULE in 1 BOTTLE None
3 NDC:46708-269-71 500 CAPSULE in 1 BOTTLE None
4 NDC:46708-269-91 1000 CAPSULE in 1 BOTTLE None
5 NDC:46708-269-12 80 CAPSULE in 1 CARTON None
6 NDC:46708-269-10 100 CAPSULE in 1 CARTON None
7 NDC:46708-269-60 60 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204519 08/22/2015
CELECOXIB celecoxib capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-270
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CELECOXIB (CELECOXIB) CELECOXIB 400 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CROSCARMELLOSE SODIUM
POVIDONE K30
SODIUM LAURYL SULFATE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
GELATIN
SHELLAC
PROPYLENE GLYCOL
FERRIC OXIDE YELLOW
FD&C BLUE NO. 2
Product Characteristics
Color WHITE (Opaque white) Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code A;137
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-270-30 30 CAPSULE in 1 BOTTLE None
2 NDC:46708-270-60 60 CAPSULE in 1 BOTTLE None
3 NDC:46708-270-71 500 CAPSULE in 1 BOTTLE None
4 NDC:46708-270-10 100 CAPSULE in 1 CARTON None
5 NDC:46708-270-14 126 CAPSULE in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204519 08/22/2015
Labeler — Alembic Pharmaceuticals Limited (650574663)
Establishment
Name Address ID/FEI Operations
Alembic Pharmaceuticals Limited 650574671 MANUFACTURE (46708-267), MANUFACTURE (46708-268), MANUFACTURE (46708-269), MANUFACTURE (46708-270)

Revised: 09/2019 Alembic Pharmaceuticals Limited

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.