Sulfasalazine

Product NDC
0603-5801
11-digit product format
006035801
Labeler code
0603
Product ID
0603-5801_6706375c-9731-4dc7-b777-1459079a6419
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sulfasalazine
Dosage form
TABLET
Route
ORAL
Labeler
Par Pharmaceutical
Application
ANDA040349
Marketing category
ANDA
Marketing start
2002-01-11
Marketing end
2019-07-31
Substance
SULFASALAZINE
Active strength
500 mg/1
Pharmacologic classes
Aminosalicylate [EPC],Aminosalicylic Acids [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0603-5801-04EA - Each0603-5801fbd87adf-25f9-4357-9ca9-644e7cac474212012-07-24
0603-5801-21EA - Each0603-58016df961cf-a3fe-4076-b877-882d9531b59112012-07-24
0603-5801-28EA - Each0603-5801b78259a9-55f8-4e1e-942d-e285c16f2c0512012-07-24
0603-5801-32EA - Each0603-5801dcce3202-e966-4ec7-ba58-ac2e10b6f27e12012-07-24

DailyMed Socrata Ingredients#

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198232sulfaSALAzine 500 MG Oral TabletPSN0ff320ac-60e1-4b75-e054-00144ff88e881
198232sulfaSALAzine 500 MG Oral TabletPSN2fc8c918-157c-4898-9b26-80d9ae2fc1431
198232sulfasalazine 500 MG Oral TabletSCD0ff320ac-60e1-4b75-e054-00144ff88e881
198232sulfasalazine 500 MG Oral TabletSCD2fc8c918-157c-4898-9b26-80d9ae2fc1431