What is NDC 62135-201?

62135-201 is the product NDC for Methenamine Mandelate, Methenamine mandelate 1000 mg/1 tablet, film coated, listed with the FDA by Chartwell RX, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

Chartwell RX, LLC, NDC labeler code 62135. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Methenamine Mandelate NDC 62135-201

NDC codes

FDA NDC Directory

Product NDC (as listed)62135-201Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62135-0201Add 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
62135-201-01	6213502010162135020101	100 TABLET, FILM COATED in 1 BOTTLE (62135-201-01)Marketed from Oct 1, 2021
62135-201-12	6213502011262135020112	120 TABLET, FILM COATED in 1 BOTTLE (62135-201-12)Marketed from Oct 1, 2021
62135-201-60	6213502016062135020160	60 TABLET, FILM COATED in 1 BOTTLE (62135-201-60)Marketed from Oct 1, 2021

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 — 1000 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Chartwell RX, LLCNDC labeler code 62135
Product type: Prescription drug
Marketing category: Unapproved drug (other)
Marketing start: Oct 1, 2021
Listing expires: Dec 31, 2026
Identifiers: Product ID 62135-201_00225fc8-eb0d-a4cc-e063-6394a90a2acbSPL ID 00225fc8-eb0d-a4cc-e063-6394a90a2acbSPL set ID 69efa19c-64a2-41cb-a298-6e9113e57fd7RxCUI 992153, 992184UNII 695N30CINRUPC 0362135201609, 0362135200121, 0362135200015, 0362135200602, 0362135201012, 0362135201128

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

N462135020101 followed by a unit qualifier and the quantity

Package 62135-0201-01. 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 Jul 10, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE Methenamine mandelate is indicated for the suppression or elimination of bacteriuria associated with pyelonephritis, cystitis, and other chronic urinary tract infections; also those neurologic diseases leading to an infected residual urine. When used as recommended, methenamine mandelate 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 because of the nonspecific effect of formaldehyde formed in an acid urine. Prophylactic Use Rationale: Urine is a good culture medium for…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 62135-201

What is NDC 62135-201?: 62135-201 is the product NDC for Methenamine Mandelate, Methenamine mandelate 1000 mg/1 tablet, film coated, listed with the FDA by Chartwell RX, LLC. It has 3 package NDCs, 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?: Chartwell RX, LLC, NDC labeler code 62135. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Methenamine Mandelate	Methenamine mandelate 500 mg/5mL	SolutionOral	Oncora Pharma, LLC	85477-115	85477-0115-16
Methenamine Mandelate	Methenamine mandelate 500 mg/1	Tablet, Film coatedOral	Westminster Pharmaceuticals, LLC	69367-436	69367-0436-0169367-0436-60
Methenamine Mandelate	Methenamine mandelate 1000 mg/1	Tablet, Film coatedOral	Westminster Pharmaceuticals, LLC	69367-437	69367-0437-0169367-0437-60
Methenamine Mandelate	Methenamine mandelate 500 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2654	72162-2654-01
Methenamine Mandelate	Methenamine mandelate 1000 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2655	72162-2655-01
Methenamine Mandelate	Methenamine mandelate 500 mg/1	Tablet, Film coatedOral	Chartwell RX, LLC	62135-200	62135-0200-0162135-0200-1262135-0200-60
Methenamine Mandelate	Methenamine mandelate 500 mg/1	TabletOral	Edenbridge Pharmaceuticals LLC.	42799-105	42799-0105-01
Methenamine Mandelate	Methenamine mandelate 1000 mg/1	TabletOral	Edenbridge Pharmaceuticals LLC.	42799-106	42799-0106-01