What is NDC 50458-098?

50458-098 is the product NDC for Elmiron (pentosan polysulfate sodium), Pentosan polysulfate sodium 100 mg/1 capsule, gelatin coated, listed with the FDA by Janssen Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Janssen Pharmaceuticals, Inc., NDC labeler code 50458. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Elmiron?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Elmiron NDC 50458-098 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)50458-098Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50458-0098Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
50458-098-01	50458009801	100 CAPSULE, GELATIN COATED in 1 BOTTLE (50458-098-01)Marketed from Sep 26, 1996

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Elmiron
Generic name (nonproprietary): pentosan polysulfate sodium
Active ingredients: Pentosan polysulfate sodium — 100 mg/1
Dosage form: Capsule, Gelatin coated
Route: Oral
Labeler: Janssen Pharmaceuticals, Inc.NDC labeler code 50458
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 020193
Marketing start: Sep 26, 1996
Listing expires: Dec 31, 2026
Other FDA classes: Glycosaminoglycans (Chemical structure)
Identifiers: Product ID 50458-098_2268b774-ecba-3038-e063-6394a90a9210SPL ID 2268b774-ecba-3038-e063-6394a90a9210SPL set ID f0ba651e-3d8a-11df-8fbe-119855d89593RxCUI 199498, 211140UNII 914032762YUPC 0350458098013
Pharmacologic class: Glycosaminoglycan

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N450458009801 followed by a unit qualifier and the quantity

Package 50458-0098-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Sep 18, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE ELMIRON ® (pentosan polysulfate sodium) is indicated for the relief of bladder pain or discomfort associated with interstitial cystitis.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50458-098

What is NDC 50458-098?: 50458-098 is the product NDC for Elmiron (pentosan polysulfate sodium), Pentosan polysulfate sodium 100 mg/1 capsule, gelatin coated, listed with the FDA by Janssen Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Elmiron (Pentosan polysulfate sodium).
What is the active ingredient?: Pentosan polysulfate sodium.
Who is the labeler?: Janssen Pharmaceuticals, Inc., NDC labeler code 50458. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Elmiron?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Elmiron (Pentosan polysulfate sodium) NDC 50458-098