FDA.reportPublic FDA data

Azulfidine

Product NDC
0013-0101
11-digit product format
000130101
Labeler code
0013
Product ID
0013-0101_cb6e4f45-60ee-44cd-a4d3-ea2445d5bda6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfasalazine
Dosage form
TABLET
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFASALAZINE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3XC8GUZ6CB
Rxcui198232, 208437

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
0013-0101-01Azulfidine100 in 1 BOTTLETABLET10027
0013-0101-10Azulfidine1 in 1 CARTONTABLET127
0013-0101-10Azulfidine100 in 1 BOTTLETABLET10027
0013-0101-20Azulfidine300 in 1 BOTTLETABLET30027
0013-0101-30Azulfidine1 in 1 CARTONTABLET127
0013-0101-30Azulfidine300 in 1 BOTTLETABLET30027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0013-0101-01EA - Each0013-010184c9b0db-da8b-4412-b996-cdb6262134e612012-07-24
0013-0101-10EA - Each0013-0101a623cb61-e660-4b42-ab05-570c3e5601eb12020-04-20
0013-0101-20EA - Each0013-010154320fe9-a664-4b62-84e3-c09daf15e7c612012-07-24
0013-0101-30EA - Each0013-01012766a571-85db-4ef3-b20c-9ea7c61eb5ec12021-02-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFASALAZINEACTIVE INGREDIENT3XC8GUZ6CBAZULFIDINE (SULFASALAZINE) TABLET [PHARMACIA AND UPJOHN COMPANY]12
SULFASALAZINEACTIVE MOIETY3XC8GUZ6CBAZULFIDINE (SULFASALAZINE) TABLET [PHARMACIA AND UPJOHN COMPANY]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZULFIDINE (SULFASALAZINE) TABLET [PHARMACIA AND UPJOHN COMPANY]12
POVIDONESINACTIVE INGREDIENTFZ989GH94EAZULFIDINE (SULFASALAZINE) TABLET [PHARMACIA AND UPJOHN COMPANY]12
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AZULFIDINE (SULFASALAZINE) TABLET [PHARMACIA AND UPJOHN COMPANY]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0013-0101AZULFIDINE (SULFASALAZINE) TABLET [PFIZER LABORATORIES DIV PFIZER INC]27Current NDC, Legacy NDC, 6 package rows20250410_ddbe69f3-bd55-45f3-a64f-f60226c744c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
208437Azulfidine 500 MG Oral TabletPSNddbe69f3-bd55-45f3-a64f-f60226c744c428
198232sulfaSALAzine 500 MG Oral TabletPSNddbe69f3-bd55-45f3-a64f-f60226c744c428
208437sulfasalazine 500 MG Oral Tablet [Azulfidine]SBDddbe69f3-bd55-45f3-a64f-f60226c744c428
198232sulfasalazine 500 MG Oral TabletSCDddbe69f3-bd55-45f3-a64f-f60226c744c428
208437Azulfidine 500 MG Oral TabletSYddbe69f3-bd55-45f3-a64f-f60226c744c428

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0013-0101-0100013010101100 TABLET in 1 BOTTLE (0013-0101-01) 100 tablet1950-06-202024-08-31NoNoCurrent
0013-0101-10000130101101 BOTTLE in 1 CARTON (0013-0101-10) / 100 TABLET in 1 BOTTLE1 bottle2020-02-270000-00-00NoNoCurrent
0013-0101-2000013010120300 TABLET in 1 BOTTLE (0013-0101-20) 300 tablet1950-06-202023-08-31NoNoCurrent
0013-0101-30000130101301 BOTTLE in 1 CARTON (0013-0101-30) / 300 TABLET in 1 BOTTLE1 bottle2020-02-270000-00-00NoNoCurrent