NDC codes

FDA NDC Directory
Product NDC (as listed)72603-816Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72603-0816Add 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
72603-816-017260308160172603081601100 TABLET in 1 BOTTLE (72603-816-01)Marketed from Apr 1, 2025

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 Hippurate
Generic name (nonproprietary)
methenamine hippurate
Active ingredients
Methenamine hippurate — 1 g/1
Dosage form
Tablet
Route
Oral
Labeler
NorthStar Rx LLCNDC labeler code 72603
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205661
Marketing start
Listing expires
Identifiers
Product ID 72603-816_83850c2e-5867-4acb-bd35-1261adb5b126SPL ID 83850c2e-5867-4acb-bd35-1261adb5b126SPL set ID 3c9e5bea-f61d-48c3-8e05-640eccccf2baRxCUI 992150UNII M329791L57

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

N472603081601 followed by a unit qualifier and the quantity

Package 72603-0816-01. 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 Methenamine hippurate tablets USP are indicated for prophylactic or suppressive treatment of frequently recurring urinary tract infections when long-term therapy is considered necessary. This drug should only be used after eradication of the infection by other appropriate antimicrobial agents. To reduce the development of drug-resistant bacteria and maintain the effectiveness of methenamine hippurate tablets USP and other antibacterial drugs, methenamine hippurate tablets USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be consid…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72603-816

What is NDC 72603-816?
72603-816 is the product NDC for Methenamine Hippurate, Methenamine hippurate 1 g/1 tablet, listed with the FDA by NorthStar Rx LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Methenamine Hippurate.
What is the active ingredient?
Methenamine hippurate.
Who is the labeler?
NorthStar Rx LLC, NDC labeler code 72603. 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 Hippurate?
11 other product NDCs are listed under this name. See all Methenamine Hippurate 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 Hippurate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Methenamine HippurateMethenamine hippurate 1 g/1TabletOralANI Pharmaceuticals, Inc.70954-95970954-0959-10
Methenamine hippurateMethenamine hippurate 1 g/1TabletOralZydus Lifesciences Limited70771-191970771-1919-01
Methenamine hippurateMethenamine hippurate 1 g/1TabletOralViona Pharmaceuticals Inc72578-17572578-0175-01
Methenamine HippurateMethenamine hippurate 1 g/1TabletOralJubilant Cadista Pharmaceuticals Inc.59746-79759746-0797-0159746-0797-65
Methenamine HippurateMethenamine hippurate 1000 mg/1TabletOralAmerican Health Packaging60687-69460687-0694-21
Methenamine HippurateMethenamine hippurate 1 g/1TabletOralIngenus Pharmaceuticals, LLC50742-14250742-0142-01
Methenamine HippurateMethenamine hippurate 1000 mg/1TabletOralAvPAK50268-54950268-0549-15
Methenamine HippurateMethenamine hippurate 1 g/1TabletOralGolden State Medical Supply, Inc.51407-88051407-0880-01
Methenamine HippurateMethenamine hippurate 1000 mg/1TabletOralMicro Labs Limited42571-33242571-0332-0142571-0332-23
Methenamine HippurateMethenamine hippurate 1 g/1TabletOralAurobindo Pharma Limited65862-78265862-0782-01

All 12 Methenamine Hippurate NDCs

Other NDCs under ANDA 205661

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 205661
ProductStrengthForm · routeLabelerProduct NDC
Methenamine HippurateMethenamine hippurate 1 g/1TabletOralAurobindo Pharma Limited65862-782

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