Home NDC 50458-098 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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020193-001 ELMIRON PENTOSAN POLYSULFATE SODIUM 100MG CAPSULE / ORAL RLD, RS 1996-09-26
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.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base ELMIRON
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PENTOSAN POLYSULFATE SODIUM 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 914032762Y Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199498 Internal RxNorm lookup 211140 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50458-098-01 ELMIRON 100 in 1 BOTTLE CAPSULE, GELATIN COATED 100 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PENTOSAN POLYSULFATE SODIUM ACTIVE INGREDIENT 914032762Y ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [JANSSEN PHARMACEUTICALS, INC.] 7 PENTOSAN POLYSULFATE ACTIVE MOIETY F59P8B75R4 ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [JANSSEN PHARMACEUTICALS, INC.] 7 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [JANSSEN PHARMACEUTICALS, INC.] 7 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [JANSSEN PHARMACEUTICALS, INC.] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [JANSSEN PHARMACEUTICALS, INC.] 7 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [JANSSEN PHARMACEUTICALS, INC.] 7 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [JANSSEN PHARMACEUTICALS, INC.] 7 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [JANSSEN PHARMACEUTICALS, INC.] 7 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [JANSSEN PHARMACEUTICALS, INC.] 7 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [JANSSEN PHARMACEUTICALS, INC.] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [JANSSEN PHARMACEUTICALS, INC.] 7 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [JANSSEN PHARMACEUTICALS, INC.] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [JANSSEN PHARMACEUTICALS, INC.] 7 PENTOSAN POLYSULFATE SODIUM ACTIVE INGREDIENT 914032762Y ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.] 2 PENTOSAN POLYSULFATE ACTIVE MOIETY F59P8B75R4 ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.] 2 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.] 2 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50458-098 ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [JANSSEN PHARMACEUTICALS, INC.] 16 Current NDC, Legacy NDC, 1 package rows 20240920_f0ba651e-3d8a-11df-8fbe-119855d89593.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ELMIRON PENTOSAN POLYSULFATE SODIUM Janssen Pharmaceuticals, Inc. f0ba651e-3d8a-11df-8fbe-119855d89593 2024-09-18 Warnings, Adverse reactions Exact identifier application applno (NDA): 020193 application number: NDA020193 ndc (product): 50458-098
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 50458-098-01 50458009801 100 CAPSULE, GELATIN COATED in 1 BOTTLE (50458-098-01) 1996-09-26 0000-00-00 No No Current