FDA.reportPublic FDA data

Sulfasalazine

Product NDC
10544-288
11-digit product format
105440288
Labeler code
10544
Product ID
10544-288_0ff320ac-60e2-4b75-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sulfasalazine
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA040349
Marketing category
ANDA
Marketing start
2013-11-18
Marketing end
0000-00-00
Substance
SULFASALAZINE
Active strength
500 mg/1
Pharmacologic classes
Aminosalicylate [EPC],Aminosalicylic Acids [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct10544-288IInactivated by FDA2026-07-31
excluded packagepackage10544-28810544-288-30IInactivated by FDA2026-07-31

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
A040349-001SULFASALAZINESULFASALAZINE500MGTABLET / ORALAB2002-01-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040349-001AB

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 22:54:322026-06A040349-001SULFASALAZINE500MGTABLET / ORALAB2002-01-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A040349-001AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SulfasalazineSULFASALAZINESunrise Pharmaceutical, Inc.a54b31cc-205d-43d3-a850-acf4b41fbc372025-09-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040349
application number: ANDA040349

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
4c7fc883-c26b-34ca-837e-8c55868a2f87Product name120140508
56183ade-c831-0ad5-5cd8-c6b0b66bfab0Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10544-288-302020-01-31C16284748780-19d75b9cf-f059-f424-e053-dadaa90a57ceSULFASALAZINE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-288-30Sulfasalazine30 in 1 BOTTLE, PLASTICTABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-288-30EA - Each10544-288d056ad78-68a7-4f40-908d-4c7d259d4faa12015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFASALAZINEACTIVE INGREDIENT3XC8GUZ6CBSULFASALAZINE TABLET [BLENHEIM PHARMACAL, INC.]1
SULFASALAZINEACTIVE MOIETY3XC8GUZ6CBSULFASALAZINE TABLET [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USULFASALAZINE TABLET [BLENHEIM PHARMACAL, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SULFASALAZINE TABLET [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULFASALAZINE TABLET [BLENHEIM PHARMACAL, INC.]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XSULFASALAZINE TABLET [BLENHEIM PHARMACAL, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSULFASALAZINE TABLET [BLENHEIM PHARMACAL, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1USULFASALAZINE TABLET [BLENHEIM PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-288SULFASALAZINE TABLET [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 1 package rows20150226_0ff320ac-60e1-4b75-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198232sulfaSALAzine 500 MG Oral TabletPSN0ff320ac-60e1-4b75-e054-00144ff88e881
198232sulfasalazine 500 MG Oral TabletSCD0ff320ac-60e1-4b75-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-288-301054402883030 in 1 BOTTLE, PLASTICHistorical