FDA.reportPublic FDA data

Azulfidine

Product NDC
0013-0102
Requested package NDC
0013-0102-20
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0013-01020013-0102-20DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N007073-001AZULFIDINESULFASALAZINE500MGTABLET / ORALABRLD, RS, Approved before 1982
N007073-002AZULFIDINE EN-TABSSULFASALAZINE500MGTABLET, DELAYED RELEASE / ORALABRLD, RS1983-04-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N007073-001AB
N007073-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N007073-001AZULFIDINE500MGTABLET / ORALABRLD, RS, Approved before 1982a50c72e98297…
2026-08-01 22:54:322026-06N007073-002AZULFIDINE EN-TABS500MGTABLET, DELAYED RELEASE / ORALABRLD, RS1983-04-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N007073-001AB1a50c72e98297…
2026-08-01 22:54:322026-06N007073-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AzulfidineSULFASALAZINEPfizer Laboratories Div Pfizer Incddbe69f3-bd55-45f3-a64f-f60226c744c42026-05-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 007073
application number: NDA007073
Azulfidine EN-tabsSULFASALAZINEPfizer Laboratories Div Pfizer Incb9ef541a-93c8-4428-ba45-398aa0b327d12026-05-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 007073
application number: NDA007073
ndc (package): 0013-0102-20
ndc (product): 0013-0102
ndc11 (package): 00013010220
SulfasalazineSULFASALAZINEREMEDYREPACK INC.88441a9f-b4f9-455d-a355-46fb30699a7b2026-01-28Warnings, Adverse reactionsExact identifier
application applno (NDA): 007073
application number: NDA007073
SulfasalazineSULFASALAZINEMylan Pharmaceuticals Inc.257cee60-b68f-4c2b-b57d-8e4d73d17e092025-05-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 007073
application number: NDA007073
SulfasalazineSULFASALAZINEMylan Pharmaceuticals Inc.48fbc535-a33a-45ee-85ff-9d1ec9b31d9c2025-05-28Warnings, Adverse reactionsExact identifier
application applno (NDA): 007073
application number: NDA007073
SulfasalazineSULFASALAZINEA-S Medication Solutions76b532a3-e7ca-4929-8c51-c0f66e0806a82025-04-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 007073
application number: NDA007073
SulfasalazineSULFASALAZINEA-S Medication Solutions32fd1726-ed81-4441-9594-3aecf2db1dbf2025-04-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 007073
application number: NDA007073
SulfasalazineSULFASALAZINEAphena Pharma Solutions - Tennessee, LLCbf5137fe-60ed-4497-8521-eeb0a684fabf2023-05-16Warnings, Adverse reactionsExact identifier
application applno (NDA): 007073
application number: NDA007073

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3XC8GUZ6CBInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313142Internal RxNorm lookup
724154Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b9ef541a-93c8-4428-ba45-398aa0b327d1Available on FDA.report

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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0013-0102-2000013010220300 TABLET, DELAYED RELEASE in 1 BOTTLE (0013-0102-20) 1950-06-202022-05-31NoNoCurrent