NDC Code(s) : 0013-0101-01, 0013-0101-20, 0013-0101-10, 0013-0101-30
Packager : Pfizer Laboratories Div Pfizer Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AzulfidineSulfasalazine 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(UNII: 3XC8GUZ6CB)
(SULFASALAZINE - UNII:3XC8GUZ6CB) 		SULFASALAZINE500 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color YELLOW (Gold) Score 2 pieces
Shape ROUND Size 14 mm
Flavor Imprint Code 101;KPh
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0013-0101-01100 in 1 BOTTLE Type 0: Not a Combination Product20/06/1950
2NDC:0013-0101-20300 in 1 BOTTLE Type 0: Not a Combination Product20/06/1950
3NDC:0013-0101-101 in 1 CARTON 27/02/2020
3100 in 1 BOTTLE Type 0: Not a Combination Product20/06/1950
4NDC:0013-0101-301 in 1 CARTON 27/02/2020
4300 in 1 BOTTLE Type 0: Not a Combination Product20/06/1950
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)

PRINCIPAL DISPLAY PANEL

Pfizer
NDC 0013-0101-01
Rx Only

Azulfidine®

sulfasalazine
tablets, USP

500 mg

100 Tablets

PRINCIPAL DISPLAY PANEL - 500 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL

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