FDA.reportPublic FDA data

ELMIRON

Product NDC
50458-098
11-digit product format
504580098
Labeler code
50458
Product ID
50458-098_2268b774-ecba-3038-e063-6394a90a9210
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PENTOSAN POLYSULFATE SODIUM
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Janssen Pharmaceuticals, Inc.
Application
NDA020193
Marketing category
NDA
Marketing start
1996-09-26
Substance
PENTOSAN POLYSULFATE SODIUM
Active strength
100 mg/1
Pharmacologic classes
Glycosaminoglycan [EPC], Glycosaminoglycans [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ELMIRON
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PENTOSAN POLYSULFATE SODIUM100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii914032762Y
Rxcui199498, 211140

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0fbf7978-a66d-d22e-cf47-78546f9f9c42Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50458-098-01ELMIRON100 in 1 BOTTLECAPSULE, GELATIN COATED10016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50458-098-01EA - Each50458-0984cce362d-6019-46db-b564-516c67fd909212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PENTOSAN POLYSULFATE SODIUMACTIVE INGREDIENT914032762YELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [JANSSEN PHARMACEUTICALS, INC.]7
PENTOSAN POLYSULFATEACTIVE MOIETYF59P8B75R4ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [JANSSEN PHARMACEUTICALS, INC.]7
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [JANSSEN PHARMACEUTICALS, INC.]7
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [JANSSEN PHARMACEUTICALS, INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [JANSSEN PHARMACEUTICALS, INC.]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [JANSSEN PHARMACEUTICALS, INC.]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [JANSSEN PHARMACEUTICALS, INC.]7
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [JANSSEN PHARMACEUTICALS, INC.]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [JANSSEN PHARMACEUTICALS, INC.]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [JANSSEN PHARMACEUTICALS, INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [JANSSEN PHARMACEUTICALS, INC.]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [JANSSEN PHARMACEUTICALS, INC.]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [JANSSEN PHARMACEUTICALS, INC.]7
PENTOSAN POLYSULFATE SODIUMACTIVE INGREDIENT914032762YELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]2
PENTOSAN POLYSULFATEACTIVE MOIETYF59P8B75R4ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50458-098ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [JANSSEN PHARMACEUTICALS, INC.]16Current NDC, Legacy NDC, 1 package rows20240920_f0ba651e-3d8a-11df-8fbe-119855d89593.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
211140Elmiron 100 MG Oral CapsulePSNf0ba651e-3d8a-11df-8fbe-119855d8959316
199498pentosan polysulfate sodium 100 MG Oral CapsulePSNf0ba651e-3d8a-11df-8fbe-119855d8959316
211140pentosan polysulfate 100 MG Oral Capsule [Elmiron]SBDf0ba651e-3d8a-11df-8fbe-119855d8959316
199498pentosan polysulfate 100 MG Oral CapsuleSCDf0ba651e-3d8a-11df-8fbe-119855d8959316
211140Elmiron 100 MG Oral CapsuleSYf0ba651e-3d8a-11df-8fbe-119855d8959316

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50458-098-0150458009801100 CAPSULE, GELATIN COATED in 1 BOTTLE (50458-098-01) 1996-09-260000-00-00NoNoCurrent