FDA.reportPublic FDA data

Azulfidine

Product NDC
0013-0102
11-digit product format
000130102
Labeler code
0013
Product ID
0013-0102_e085ce86-abc0-4032-a3c9-ca89bae152d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfasalazine
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
NDA007073
Marketing category
NDA
Marketing start
1950-06-20
Substance
SULFASALAZINE
Active strength
500 mg/1
Pharmacologic classes
Aminosalicylate [EPC], Aminosalicylic Acids [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Azulfidine
Brand name suffix
EN-tabs
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFASALAZINE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3XC8GUZ6CB
Rxcui313142, 724154

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4c7fc883-c26b-34ca-837e-8c55868a2f87Product name120140508
56183ade-c831-0ad5-5cd8-c6b0b66bfab0Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0013-0102-01AzulfidineEN-tabs100 in 1 BOTTLETABLET, DELAYED RELEASE10033
0013-0102-20AzulfidineEN-tabs300 in 1 BOTTLETABLET, DELAYED RELEASE30033
0013-0102-50AzulfidineEN-tabs100 in 1 BOTTLETABLET, DELAYED RELEASE10033
0013-0102-50AzulfidineEN-tabs1 in 1 CARTONTABLET, DELAYED RELEASE133
0013-0102-60AzulfidineEN-tabs1 in 1 CARTONTABLET, DELAYED RELEASE133
0013-0102-60AzulfidineEN-tabs300 in 1 BOTTLETABLET, DELAYED RELEASE30033

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0013-0102-01EA - Each0013-01025fa718d1-06d6-4cb8-a812-7efbfbd0aa6612012-07-24
0013-0102-20EA - Each0013-0102beb25547-6e8a-493c-9d39-2b74bd43fbdc12012-07-24
0013-0102-50EA - Each0013-01023140cdf2-9055-4a4d-9920-c091c52e0d7412020-08-06
0013-0102-60EA - Each0013-0102d9ef4fe8-1bdc-48e5-bc41-b33cf1a8f73e12021-06-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFASALAZINEACTIVE INGREDIENT3XC8GUZ6CBAZULFIDINE EN-TABS (SULFASALAZINE) TABLET, DELAYED RELEASE [PHARMACIA AND UPJOHN COMPANY]11
SULFASALAZINEACTIVE MOIETY3XC8GUZ6CBAZULFIDINE EN-TABS (SULFASALAZINE) TABLET, DELAYED RELEASE [PHARMACIA AND UPJOHN COMPANY]11
ACETONEINACTIVE INGREDIENT1364PS73AFAZULFIDINE EN-TABS (SULFASALAZINE) TABLET, DELAYED RELEASE [PHARMACIA AND UPJOHN COMPANY]11
ALCOHOLINACTIVE INGREDIENT3K9958V90MAZULFIDINE EN-TABS (SULFASALAZINE) TABLET, DELAYED RELEASE [PHARMACIA AND UPJOHN COMPANY]11
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZAZULFIDINE EN-TABS (SULFASALAZINE) TABLET, DELAYED RELEASE [PHARMACIA AND UPJOHN COMPANY]11
CELLULOSE ACETATEINACTIVE INGREDIENT3J2P07GVB6AZULFIDINE EN-TABS (SULFASALAZINE) TABLET, DELAYED RELEASE [PHARMACIA AND UPJOHN COMPANY]11
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4AZULFIDINE EN-TABS (SULFASALAZINE) TABLET, DELAYED RELEASE [PHARMACIA AND UPJOHN COMPANY]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZULFIDINE EN-TABS (SULFASALAZINE) TABLET, DELAYED RELEASE [PHARMACIA AND UPJOHN COMPANY]11
POVIDONESINACTIVE INGREDIENTFZ989GH94EAZULFIDINE EN-TABS (SULFASALAZINE) TABLET, DELAYED RELEASE [PHARMACIA AND UPJOHN COMPANY]11
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3AZULFIDINE EN-TABS (SULFASALAZINE) TABLET, DELAYED RELEASE [PHARMACIA AND UPJOHN COMPANY]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AZULFIDINE EN-TABS (SULFASALAZINE) TABLET, DELAYED RELEASE [PHARMACIA AND UPJOHN COMPANY]11
TALCINACTIVE INGREDIENT7SEV7J4R1UAZULFIDINE EN-TABS (SULFASALAZINE) TABLET, DELAYED RELEASE [PHARMACIA AND UPJOHN COMPANY]11
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FAZULFIDINE EN-TABS (SULFASALAZINE) TABLET, DELAYED RELEASE [PHARMACIA AND UPJOHN COMPANY]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0013-0102AZULFIDINE EN-TABS (SULFASALAZINE) TABLET, DELAYED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]32Current NDC, Legacy NDC, 6 package rows20250410_b9ef541a-93c8-4428-ba45-398aa0b327d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
724154Azulfidine EN-tabs 500 MG Delayed Release Oral TabletPSNb9ef541a-93c8-4428-ba45-398aa0b327d134
313142sulfaSALAzine 500 MG Delayed Release Oral TabletPSNb9ef541a-93c8-4428-ba45-398aa0b327d134
724154sulfasalazine 500 MG Delayed Release Oral Tablet [Azulfidine]SBDb9ef541a-93c8-4428-ba45-398aa0b327d134
313142sulfasalazine 500 MG Delayed Release Oral TabletSCDb9ef541a-93c8-4428-ba45-398aa0b327d134
724154Azulfidine 500 MG Delayed Release Oral TabletSYb9ef541a-93c8-4428-ba45-398aa0b327d134
724154Azulfidine EN-tabs 500 MG Delayed Release Oral TabletSYb9ef541a-93c8-4428-ba45-398aa0b327d134

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0013-0102-0100013010201100 TABLET, DELAYED RELEASE in 1 BOTTLE (0013-0102-01) 1950-06-202024-03-31NoNoCurrent
0013-0102-2000013010220300 TABLET, DELAYED RELEASE in 1 BOTTLE (0013-0102-20) 1950-06-200000-00-00NoNoCurrent
0013-0102-50000130102501 BOTTLE in 1 CARTON (0013-0102-50) / 100 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2020-07-070000-00-00NoNoCurrent
0013-0102-60000130102601 BOTTLE in 1 CARTON (0013-0102-60) / 300 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2021-02-150000-00-00NoNoCurrent