FDA.reportPublic FDA data

Sulfasalazine

Product NDC
63629-5688
Requested package NDC
63629-5688-3
11-digit product format
636295688
Labeler code
63629
Product ID
63629-5688_132090c1-191f-4acf-859d-162c5940debd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfasalazine
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA085828
Marketing category
ANDA
Marketing start
1982-10-01
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 packagepackage63629-568863629-5688-3DDiscontinued 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 Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-5688-12024-01-30C16284748780-19d75b9d0-8a7f-f424-e053-dadaa90a57ceSulfasalazine Tablets, USP Rx only
63629-5688-22024-01-30C16284748780-19d75b9d0-8a7f-f424-e053-dadaa90a57ceSulfasalazine Tablets, USP Rx only
63629-5688-32024-01-30C16284748780-19d75b9d0-8a7f-f424-e053-dadaa90a57ceSulfasalazine Tablets, USP Rx only
63629-5688-42024-01-30C16284748780-19d75b9d0-8a7f-f424-e053-dadaa90a57ceSulfasalazine Tablets, USP Rx only
63629-5688-12020-10-16C16284748780-19d75b9d0-8a7f-f424-e053-dadaa90a57ceSulfasalazine Tablets, USP Rx only
63629-5688-22020-10-16C16284748780-19d75b9d0-8a7f-f424-e053-dadaa90a57ceSulfasalazine Tablets, USP Rx only
63629-5688-32020-10-16C16284748780-19d75b9d0-8a7f-f424-e053-dadaa90a57ceSulfasalazine Tablets, USP Rx only
63629-5688-42020-10-16C16284748780-19d75b9d0-8a7f-f424-e053-dadaa90a57ceSulfasalazine Tablets, USP Rx only
63629-5688-12020-01-31C16284748780-19d75b9d0-8a7f-f424-e053-dadaa90a57ceSulfasalazine Tablets, USP Rx only
63629-5688-22020-01-31C16284748780-19d75b9d0-8a7f-f424-e053-dadaa90a57ceSulfasalazine Tablets, USP Rx only
63629-5688-32020-01-31C16284748780-19d75b9d0-8a7f-f424-e053-dadaa90a57ceSulfasalazine Tablets, USP Rx only
63629-5688-42020-01-31C16284748780-19d75b9d0-8a7f-f424-e053-dadaa90a57ceSulfasalazine Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-5688-1Sulfasalazine30 in 1 BOTTLETABLET306
63629-5688-2Sulfasalazine60 in 1 BOTTLETABLET606
63629-5688-3Sulfasalazine90 in 1 BOTTLETABLET906
63629-5688-4Sulfasalazine120 in 1 BOTTLETABLET1206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-5688SULFASALAZINE TABLET [BRYANT RANCH PREPACK]6Legacy NDC, 4 package rows20220312_1ac35416-0603-44e3-9199-e0639b4de4f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198232sulfaSALAzine 500 MG Oral TabletPSN1ac35416-0603-44e3-9199-e0639b4de4f06
198232sulfasalazine 500 MG Oral TabletSCD1ac35416-0603-44e3-9199-e0639b4de4f06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-5688-36362956880390 TABLET in 1 BOTTLE (63629-5688-3) 90 tablet2017-09-060000-00-00NoNoCurrent