NDC codes

FDA NDC Directory
Product NDC (as listed)42799-105Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42799-0105Add 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
42799-105-014279901050142799010501100 TABLET in 1 BOTTLE (42799-105-01)Marketed from Dec 15, 2009

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)
Methenamine Mandelate
Generic name (nonproprietary)
methenamine mandelate
Active ingredients
Methenamine mandelate — 500 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Edenbridge Pharmaceuticals LLC.NDC labeler code 42799
Product type
Prescription drug
Marketing category
Unapproved drug (other)
Marketing start
Listing expires
Identifiers
Product ID 42799-105_03695bb1-8e07-4862-b517-04c39d9abee1SPL ID 03695bb1-8e07-4862-b517-04c39d9abee1SPL set ID cc299e8a-cf9a-4dc6-b6e6-972141e59296RxCUI 992153, 992184UNII 695N30CINRUPC 0342799105017, 0342799106014

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

N442799010501 followed by a unit qualifier and the quantity

Package 42799-0105-01. 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)

INDICATIONS AND USAGE Methenamine mandelate, USP is indicated for the suppression or elimination of bacteriuria associated with pyelonephritis, cystitis, and other chronic urinary tract infections; also for infected residual urine sometimes accompanying neurologic diseases. When used as recommended, methenamine mandelate, USP is particularly suitable for long-term therapy because of its safety and because resistance to the nonspecific bactericidal action of formaldehyde does not develop. Pathogens resistant to other antibacterial agents may respond to methenamine mandelate, USP because of the nonspecific effect of formaldehyde formed in an acid urine. Prophylactic Use Rationale: Urine is a g…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42799-105

What is NDC 42799-105?
42799-105 is the product NDC for Methenamine Mandelate, Methenamine mandelate 500 mg/1 tablet, listed with the FDA by Edenbridge Pharmaceuticals LLC.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Methenamine Mandelate.
What is the active ingredient?
Methenamine mandelate.
Who is the labeler?
Edenbridge Pharmaceuticals LLC., NDC labeler code 42799. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Methenamine Mandelate?
8 other product NDCs are listed under this name. See all Methenamine Mandelate NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Methenamine Mandelate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Methenamine MandelateMethenamine mandelate 500 mg/5mLSolutionOralOncora Pharma, LLC85477-11585477-0115-16
Methenamine MandelateMethenamine mandelate 500 mg/1Tablet, Film coatedOralWestminster Pharmaceuticals, LLC69367-43669367-0436-0169367-0436-60
Methenamine MandelateMethenamine mandelate 1000 mg/1Tablet, Film coatedOralWestminster Pharmaceuticals, LLC69367-43769367-0437-0169367-0437-60
Methenamine MandelateMethenamine mandelate 500 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-265472162-2654-01
Methenamine MandelateMethenamine mandelate 1000 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-265572162-2655-01
Methenamine MandelateMethenamine mandelate 500 mg/1Tablet, Film coatedOralChartwell RX, LLC62135-20062135-0200-0162135-0200-1262135-0200-60
Methenamine MandelateMethenamine mandelate 1000 mg/1Tablet, Film coatedOralChartwell RX, LLC62135-20162135-0201-0162135-0201-1262135-0201-60
Methenamine MandelateMethenamine mandelate 1000 mg/1TabletOralEdenbridge Pharmaceuticals LLC.42799-10642799-0106-01

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