NDC codes

FDA NDC Directory
Product NDC (as listed)65862-782Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65862-0782Add 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
65862-782-016586207820165862078201100 TABLET in 1 BOTTLE (65862-782-01)Marketed from Jul 5, 2016

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
Aurobindo Pharma LimitedNDC labeler code 65862
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205661
Marketing start
Listing expires
Identifiers
Product ID 65862-782_58bf1607-c076-466c-a0ff-a0ecf74f84b8SPL ID 58bf1607-c076-466c-a0ff-a0ecf74f84b8SPL set ID 9f002ad9-58e7-44f2-a980-3cc3f36bbd9bRxCUI 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

N465862078201 followed by a unit qualifier and the quantity

Package 65862-0782-01. 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 65862-782

What is NDC 65862-782?
65862-782 is the product NDC for Methenamine Hippurate, Methenamine hippurate 1 g/1 tablet, listed with the FDA by Aurobindo Pharma Limited. 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?
Aurobindo Pharma Limited, NDC labeler code 65862. 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/1TabletOralNorthStar Rx LLC72603-81672603-0816-01
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

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/1TabletOralNorthStar Rx LLC72603-816

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