CELEBREX (Page 9 of 9)


PRINCIPAL DISPLAY PANEL — 100 mg label

Rx only

Celebrex® celecoxib capsules 100 mg

Pfizer
Distributed by
G.D. Searle LLC Division of Pfizer Inc, NY, NY 10017

PRINCIPAL DISPLAY PANEL -- 100 mg label
(click image for full-size original)


PRINCIPAL DISPLAY PANEL — 200 mg label

Rx only

Celebrex® celecoxib capsules 200 mg

Pfizer
Distributed by
G.D. Searle LLC Division of Pfizer Inc, NY, NY 10017

PRINCIPAL DISPLAY PANEL -- 200 mg label
(click image for full-size original)
CELEBREX celecoxib capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42549-642(NDC:0025-1520)
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
CROSCARMELLOSE SODIUM
GELATIN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE
SODIUM LAURYL SULFATE
Product Characteristics
Color white Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code 7767;100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42549-642-30 30 CAPSULE (CAPSULE) in 1 BOTTLE None
2 NDC:42549-642-60 60 CAPSULE (CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020998 10/02/1998
CELEBREX celecoxib capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42549-505(NDC:0025-1525)
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
CROSCARMELLOSE SODIUM
GELATIN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE
SODIUM LAURYL SULFATE
Product Characteristics
Color white Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code 7767;200
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42549-505-30 30 CAPSULE (CAPSULE) in 1 BOTTLE None
2 NDC:42549-505-60 60 CAPSULE (CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020998 10/02/1998
Labeler — STAT Rx USA LLC (786036330)
Registrant — PSS World Medical Inc (101822682)
Establishment
Name Address ID/FEI Operations
STAT Rx USA LLC 786036330 relabel, repack

Revised: 01/2012 STAT Rx USA LLC

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 © 2020. All Rights Reserved.