FDA.reportPublic FDA data

Sulfasalazine

Product NDC
50268-730
Requested package NDC
50268-730-15
11-digit product format
502680730
Labeler code
50268
Product ID
50268-730_d5dfc328-99dc-5245-e053-2a95a90a329d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfasalazine
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA085828
Marketing category
ANDA
Marketing start
2014-01-14
Marketing end
0000-00-00
Substance
SULFASALAZINE
Active strength
500 mg/1
Pharmacologic classes
Aminosalicylate [EPC], Aminosalicylic Acids [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage50268-73050268-730-15DDiscontinued 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A085828-001SULFASALAZINESULFASALAZINE500MGTABLET / ORALABApproved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A085828-001AB

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 22:54:322026-06A085828-001SULFASALAZINE500MGTABLET / ORALABApproved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A085828-001AB1a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SulfasalazineSULFASALAZINEAmerican Health Packagingd967092f-9685-446b-b7b8-17821e29417b2026-07-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085828
application number: ANDA085828
SulfasalazineSULFASALAZINEBryant Ranch Prepack618c5324-d0a6-4d00-9b12-0de88a71c1802024-04-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085828
application number: ANDA085828
SulfasalazineSULFASALAZINETeva Pharmaceuticals USA, Inc.3c59593b-e1a5-47cb-a82b-3e5e492053442023-08-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085828
application number: ANDA085828

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-730-11EA - Each50268-7300b9d17c0-c4e1-45a6-9244-6d2dec87d24112015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFASALAZINEACTIVE INGREDIENT3XC8GUZ6CBSULFASALAZINE (SULFASALAZINE) TABLET [AVPAK]2
SULFASALAZINEACTIVE MOIETY3XC8GUZ6CBSULFASALAZINE (SULFASALAZINE) TABLET [AVPAK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULFASALAZINE (SULFASALAZINE) TABLET [AVPAK]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SULFASALAZINE (SULFASALAZINE) TABLET [AVPAK]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSULFASALAZINE (SULFASALAZINE) TABLET [AVPAK]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSULFASALAZINE (SULFASALAZINE) TABLET [AVPAK]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-730-155026807301550 BLISTER PACK in 1 BOX (50268-730-15) > 1 TABLET in 1 BLISTER PACK (50268-730-11) 50 blister pack2014-01-140000-00-00NoNoCurrent