FDA.reportPublic FDA data

Sulfasalazine

Product NDC
70518-2342
11-digit product format
705182342
Labeler code
70518
Product ID
70518-2342_ef3dd891-de8b-3b47-e053-2995a90a476a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfasalazine
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA085828
Marketing category
ANDA
Marketing start
2019-10-03
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70518-2342DDiscontinued by firm2026-07-31
excluded packagepackage70518-234270518-2342-0DDiscontinued by firm2026-07-31
excluded packagepackage70518-234270518-2342-1DDiscontinued by firm2026-07-31
excluded packagepackage70518-234270518-2342-2DDiscontinued 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2342-070518234200270 TABLET in 1 BOTTLE, PLASTIC (70518-2342-0) 270 tablet2019-10-030000-00-00NoNoCurrent
70518-2342-17051823420130 TABLET in 1 BLISTER PACK (70518-2342-1) 30 tablet2020-04-220000-00-00NoNoCurrent
70518-2342-27051823420230 TABLET in 1 BLISTER PACK (70518-2342-2) 30 tablet2022-12-070000-00-00NoNoCurrent