NDC codes

FDA NDC Directory
Product NDC (as listed)58657-454Labeler and product segments. Claims need a package NDC.
Product NDC at billing width58657-0454Add 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 NDC11-digit (billing)PackageCopy
58657-454-015865704540158657045401100 TABLET in 1 BOTTLE (58657-454-01)Marketed from Dec 1, 2015

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)
Me NaPhos MB Hyo 1
Generic name (nonproprietary)
urinary antiseptic antispasmodic
Active ingredients
Methenamine — 81.6 mg/1Sodium phosphate, Monobasic, Monohydrate — 40.8 mg/1Methylene blue anhydrous — 10.8 mg/1Hyoscyamine sulfate anhydrous — .12 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Method PharmaceuticalsNDC labeler code 58657
Product type
Prescription drug
Marketing category
Unapproved drug (other)
Marketing start
Listing expires
Other FDA classes
Oxidation-Reduction Activity (Mechanism)
Identifiers
Product ID 58657-454_41b576a1-2a59-9f3c-e063-6394a90aec7dSPL ID 41b576a1-2a59-9f3c-e063-6394a90aec7dSPL set ID 2ae628e7-3b33-6a9a-e054-00144ff8d46cRxCUI 1050325UNII J50OIX95QV, 593YOG76RN, 8NAP7826UB, OB570Z127KUPC 0358657454012
Pharmacologic class
Oxidation-Reduction Agent

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

N458657045401 followed by a unit qualifier and the quantity

Package 58657-0454-01. 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 .

Indications (excerpt from the label)

INDICATION AND USAGE ME/NaPhos/MB/Hyo 1 Tablets is indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as hypermotility which accompany lower urinary tract infections and as antispasmodic. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 58657-454

What is NDC 58657-454?
58657-454 is the product NDC for Me NaPhos MB Hyo 1 (urinary antiseptic antispasmodic), Methenamine 81.6 mg/1 + 3 more ingredients tablet, listed with the FDA by Method Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Me NaPhos MB Hyo 1 (Urinary Antiseptic Antispasmodic).
What is the active ingredient?
Methenamine, Sodium phosphate, Monobasic, Monohydrate, Methylene blue anhydrous, Hyoscyamine sulfate anhydrous.
Who is the labeler?
Method Pharmaceuticals, NDC labeler code 58657. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Me NaPhos MB Hyo 1?
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.

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