Azulfidine (Page 4 of 4)

PRINCIPAL DISPLAY PANEL — 500 mg Tablet Bottle Label — 0101-10

Pfizer
NDC 0013-0101-10
Rx Only

Azulfidine®

sulfasalazine
tablets, USP

500 mg

100 Tablets

PRINCIPAL DISPLAY PANEL -- 500 mg Tablet Bottle Label -- 0101-10
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 500 mg Tablet Bottle Carton — 0101-10

Pfizer
NDC 0013-0101-10

Azulfidine®

sulfasalazine
tablets, USP

500 mg

Rx only

100 Tablets

PRINCIPAL DISPLAY PANEL -- 500 mg Tablet Bottle Carton -- 0101-10
(click image for full-size original)
AZULFIDINE
sulfasalazine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0013-0101
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SULFASALAZINE (SULFASALAZINE) SULFASALAZINE 500 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
POVIDONE, UNSPECIFIED
SILICON DIOXIDE
STARCH, CORN
Product Characteristics
Color YELLOW (Gold) Score 2 pieces
Shape ROUND Size 14mm
Flavor Imprint Code 101;KPh
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0013-0101-01 100 TABLET in 1 BOTTLE None
2 NDC:0013-0101-20 300 TABLET in 1 BOTTLE None
3 NDC:0013-0101-10 1 BOTTLE in 1 CARTON contains a BOTTLE
3 100 TABLET in 1 BOTTLE This package is contained within the CARTON (0013-0101-10)
4 NDC:0013-0101-30 1 BOTTLE in 1 CARTON contains a BOTTLE
4 300 TABLET in 1 BOTTLE This package is contained within the CARTON (0013-0101-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA007073 06/20/1950
Labeler — Pfizer Laboratories Div Pfizer Inc (134489525)
Registrant — Pfizer Inc (113480771)

Revised: 10/2022 Pfizer Laboratories Div Pfizer Inc

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