Methenamine Hippurate 1 g Tablet, 100-count — NDC 47781-577-01 (Billing 47781-0577-01)
This is a package of 100 tablets of Methenamine Hippurate 1 g Tablet from Alvogen Inc., marketed since May 2010 and currently FDA-listed, this package's marketing is listed to end Nov 2027; retail pharmacies pay about $0.3126 per tablet (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 47781-577-01 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 47781 labeler · 577 product · 01 package
- Package marketed since
- Oct 23, 2017
- Package marketing ended
- Nov 1, 2027
- Sample package
- No — commercial package
- Billing quantity
- 100 EA per package
- Barcode (UPC-A, from the NDC)
- 3 4778157701 8
- Medicaid fills, this package
- 162 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 009457
- GCN: 41980
- GPI-14 (Medi-Span): 16800020200305
- HICL (First Databank): 004101
- AHFS class code: 08:36.00.00
- RxCUI (RxNorm): 992150
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Other antibacterials class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- That's a great question. Methenamine isn't used to clear an active infection — it's used to prevent another one from taking hold. Once your other antibiotic has done that job, meth...
- Why do I need to take methenamine if my infection is already gone?
- Yes, it actually does. Methenamine only converts into its active antibacterial form in acidic urine. Foods and medications that make your urine more alkaline — less acidic — can re...
- Does it matter what I eat or drink while I'm on this medication?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Methenamine Hippurate — tap one for details:
Methenamine Hippurate may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.313 | $31.26 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.5111 | $51.11 / 100 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.5951 | $59.51 / 100 tablets |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 47781-0577-01 You're viewing this Main listing | 100 TABLET in 1 BOTTLE | 2017-10-23 | Nov 1, 2027 | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Methenamine Hippurate 1000 mg 42571-0332-01 | Micro | 100 tablets | $0.313 | AB | Availability likely | — |
| Methenamine Hippurate 1 gthis 47781-0577-01 | Alvogen | 100 tablets | $0.313 | AB | Availability likely | — |
| Methenamine Hippurate 1000 mg 50268-0549-15 | AvPAK | 50 tablets | $0.313 | AB | Availability likely | — |
| Methenamine Hippurate 1 g 50742-0142-01 | Ingenus | 100 tablets | $0.313 | AB | Availability likely | — |
| Methenamine Hippurate 1 g 59746-0797-01 | Jubilant | 100 tablets | $0.313 | AB | Availability likely | — |
| Methenamine Hippurate 1000 mg 60687-0694-21 | American | 30 tablets | $0.313 | AB | Availability likely | — |
| Methenamine Hippurate 1 g 65862-0782-01 | Aurobindo | 100 tablets | $0.313 | AB | Availability likely | — |
| Methenamine hippurate 1 g 72578-0175-01 | Viona | 100 tablets | $0.313 | AB | Availability likely | — |
| Methenamine Hippurate 1 g 72603-0816-01 | NorthStar | 100 tablets | $0.313 | AB | Availability likely | — |
| Methenamine Hippurate 1 g 70954-0959-10 | ANI | 100 tablets | $0.313 | AB | Availability likely | — |
| Methenamine Hippurate 1 g 51407-0880-01 | Golden | 100 tablets | — | AB | FDA listed | — |
| Methenamine Hippurate 1 g 70685-0050-01 | Esjay | 100 tablets | — | AB | Discontinued | — |
| Methenamine hippurate 1 g 70771-1919-01 | Zydus | 100 tablets | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
-
UNII FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
-
UNII SB8ZUX40TY
Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
3 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Alvogen Inc. labeler code 47781
- lisdexamfetamine dimesylate 20 mg Capsule NDC 47781-563-01
- lisdexamfetamine dimesylate 30 mg Capsule NDC 47781-564-01
- lisdexamfetamine dimesylate 40 mg Capsule NDC 47781-565-01
- lisdexamfetamine dimesylate 50 mg Capsule NDC 47781-566-01
- lisdexamfetamine dimesylate 60 mg Capsule NDC 47781-567-01
- lisdexamfetamine dimesylate 70 mg Capsule NDC 47781-568-01
- Disulfiram 250 mg Tablet NDC 47781-607-30
- levothyroxine sodium 25 ug Tablet NDC 47781-640-10
- levothyroxine sodium 50 ug Tablet NDC 47781-643-10
- levothyroxine sodium 75 ug Tablet NDC 47781-646-10
- levothyroxine sodium 88 ug Tablet NDC 47781-649-10
- levothyroxine sodium 100 ug Tablet NDC 47781-651-10
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of Methenamine Hippurate Tablets and other antibacterial drugs, Methenamine Hippurate Tablets 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 considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Methenamine Hippurate Tablets 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.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION One tablet (1 g) twice daily for adults and children over 12 years of age. One-half tablet or one tablet (0.5 or 1 g) twice daily for children 6 to 12 years of age. The antibacterial activity of Methenamine Hippurate Tablets is greater in acid urine.
Therefore, restriction of alkalinizing foods and medications is desirable. If necessary, as indicated by urinary pH and clinical response, supplemental acidification of the urine may be instituted. The efficacy of therapy should be monitored by repeated urine cultures.
⛔ Contraindications ▾
CONTRAINDICATIONS Methenamine Hippurate Tablets are contraindicated in patients with renal insufficiency, severe hepatic insufficiency, or severe dehydration. It should not be used as the sole therapeutic agent in acute parenchymal infections causing systemic symptoms.
⚠️ Warnings ▾
WARNINGS Patients with pre-existing hepatic insufficiency may suffer adverse effects from the small amounts of ammonia and formaldehyde that are produced. The classical syndrome of acute hepatic failure may be evoked in these patients.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Adverse effects of Methenamine Hippurate Tablets have been reported in fewer than 3.5% of patients treated. These reactions have included the following, in decreasing order of frequency: nausea, vomiting and rarely pruritus, rash, dysuria. Children have received Methenamine Hippurate Tablets at the recommended dosages as a prophylactic/suppressive regimen after initial treatment of acute episodes of pyuria.
Side effects were encountered in only 1.1% of these children.
🔄 Drug Interactions ▾
Drug Interactions: The concomitant administration of methenamine hippurate and sulfamethizole or sulfathiazole is liable to result in the formation of a precipitate in the urine.
🔄 Drug / Laboratory Test Interactions ▾
Drug/Laboratory Test Interactions: Methenamine causes spuriously elevated urinary 17-hydroxycorticosteroid and catecholamine levels.
🤰 Pregnancy ▾
Pregnancy: Teratogenic effects. Pregnancy category C. Oral administration of methenamine to pregnant dogs, at doses equivalent to the human dose, has been reported to cause a slight increase in the stillborn rate and slight impairment of weight gain and survival of live-born offspring.
A teratogenicity study, in which methenamine hippurate was administered to pregnant rabbits at doses approximately 3 times human dose, revealed no evidence of harm to the fetus. There are no adequate and well-controlled studies in pregnant women. Methenamine Hippurate Tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
🧒 Pediatric Use ▾
Pediatric Use: (see DOSAGE AND ADMINISTRATION ).
🆘 Overdosage ▾
OVERDOSAGE Immediately after ingestion of an overdose, further absorption of the drug may be minimized by inducing vomiting or by gastric lavage, followed by administration of activated charcoal. Fluids, either oral or parenteral, should be forced to tolerance.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Methenamine hippurate is readily absorbed from the GI tract. Methenamine distributes widely into body fluids, but very little is hydrolyzed prior to excretion in the kidney and thus has minimal systemic toxic potential. Within one-half hour after a single 1 g dose of a Methenamine Hippurate Tablet, antibacterial activity is demonstrable in the urine.
Urine shows continuous antibacterial activity when Methenamine Hippurate Tablets are administered at the recommended dosage schedule of 1 g twice daily. Over 90% of the methenamine moiety is excreted in the urine within twenty-four hours after administration of a single 1 g dose. Similarly, the hippurate moiety is rapidly absorbed and excreted, and it reaches the urine by both tubular secretion and glomerular filtration.
This may be of importance in older patients or those with some degree of renal impairment. Methenamine is placentally transferred to the fetus during pregnancy. Microbiology: Methenamine hippurate exerts its activity because the methenamine component is hydrolyzed to formaldehyde in acid urine.
Hippuric acid, the other component, acts to keep the urine acid. The minimal inhibitory concentrations are significantly lower in more acidic media; therefore, the efficacy of Methenamine Hippurate Tablets can be increased by acidification of urine (see DOSAGE AND ADMINISTRATION ). Microorganisms do not develop resistance to formaldehyde; however urea-splitting microorganisms (e.g.
Proteus species) tend to raise the pH of the urine thus inhibiting the release of formaldehyde. When the urine pH is 6 and the daily urine volume is 1000 -1500 mL a 2 g dose of Methenamine Hippurate Tablets daily will yield a urinary concentration of 18 to 60 μg/mL of formaldehyde, this being more than the minimal inhibitory concentration for most urinary pathogens.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Methenamine Hippurate Tablets are capsule-shaped, scored, white, debossed “CL 20” on one side. Each tablet contains methenamine hippurate 1 g. Bottles of 100 tablets (NDC 47781-577-01). Store at controlled room temperature 15°-30°C (59°-86°F).
📋 Description ▾
DESCRIPTION Methenamine Hippurate Tablets are a urinary tract antiseptic drug. Each white, scored tablet contains methenamine hippurate 1g (see HOW SUPPLIED). Methenamine Hippurate Tablets also contain: magnesium stearate, povidone and saccharin sodium. Chemically, methenamine hippurate is the hippuric acid salt of methenamine (hexamethylenetetramine). Structural formula: C 15 H 21 N 5 O 3 Molecular Weight 319.37 Methenamine structural formula
💬 Information for Patients ▾
Information for Patients: Patients should be counseled that antibacterial drugs including Methenamine Hippurate Tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g. the common cold). When Methenamine Hippurate Tablets are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.
Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Methenamine Hippurate Tablets or other antibacterial drugs in the future.
⚠️ Precautions ▾
PRECAUTIONS General: Prescribing Methenamine Hippurate Tablets in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Large doses of methenamine (8 g daily for 3 to 4 weeks) have caused bladder irritation, painful and frequent micturition, albuminuria and gross hematuria. Care should be taken to maintain an acid pH of the urine especially when treating infections due to urea-splitting organisms such as Proteus spp. and strains of Pseudomonas spp.
Information for Patients: Patients should be counseled that antibacterial drugs including Methenamine Hippurate Tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g. the common cold). When Methenamine Hippurate Tablets are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.
Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Methenamine Hippurate Tablets or other antibacterial drugs in the future. Laboratory Tests: In a few instances in one study, the serum transaminase levels showed a mild elevation during treatment which returned to normal while the patients were still receiving Methenamine Hippurate Tablets. Because of this one report, it is recommended that liver function studies be performed periodically on patients receiving the drug, especially those with liver dysfunction.
Drug Interactions: The concomitant administration of methenamine hippurate and sulfamethizole or sulfathiazole is liable to result in the formation of a precipitate in the urine. Drug/Laboratory Test Interactions: Methenamine causes spuriously elevated urinary 17-hydroxycorticosteroid and catecholamine levels. Carcinogenesis, Mutagenesis and Impairment of Fertility: Methenamine Hippurate Tablets have not been evaluated for carcinogenicity or mutagenicity.
Methenamine was evaluated for mutagenicity in the Ames Salmonella/mammalian microsome test. Five strains of Salmonella typhimurium (TA98, TA100, TA1535, TA1537 and TA1538) and a strain of Escherichia coli (WP2uvrA) were used. At a dose of 10,000 μg/plate methenamine showed mutagenic activity in Salmonella typhimurium TA98 and TA100 by metabolic activation and also showed mutagenic activity in TA98 without microsomal activation.
In one large study, no evidence of carcinogenicity was found following long-term oral administration of methenamine 1.25g/kg/day to rats ( 104 weeks ) and mice ( 60 weeks ). The same investigators also reported no suggestion of carcinogenicity resulting from five subcutaneous injections of 5 g/kg (given on alternate days for a total dose of 25 g/kg). An earlier, much smaller study showed a 50% incidence of local sarcomas following subcutaneous injection of methenamine, totaling 25 g/kg, administered over periods of up to 15 months to rats concurrently receiving formic acid.
Methenamine hippurate, administered at a dose level of 800 mg/kg/day, did not adversely affect the fertility of female rats. Effects on male fertility have not been adequately studied. Pregnancy: Teratogenic effects.
Pregnancy category C. Oral administration of methenamine to pregnant dogs, at doses equivalent to the human dose, has been reported to cause a slight increase in the stillborn rate and slight impairment of weight gain and survival of live-born offspring. A teratogenicity study, in which methenamine hippurate was administered to pregnant rabbits at doses approximately 3 times human dose, revealed no evidence of harm to the fetus.
There are no adequate and well-controlled studies in pregnant women. Methenamine Hippurate Tablets should be used durin… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
Nursing Mothers: Methenamine is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis and Impairment of Fertility: Methenamine Hippurate Tablets have not been evaluated for carcinogenicity or mutagenicity. Methenamine was evaluated for mutagenicity in the Ames Salmonella/mammalian microsome test. Five strains of Salmonella typhimurium (TA98, TA100, TA1535, TA1537 and TA1538) and a strain of Escherichia coli (WP2uvrA) were used.
At a dose of 10,000 μg/plate methenamine showed mutagenic activity in Salmonella typhimurium TA98 and TA100 by metabolic activation and also showed mutagenic activity in TA98 without microsomal activation. In one large study, no evidence of carcinogenicity was found following long-term oral administration of methenamine 1.25g/kg/day to rats ( 104 weeks ) and mice ( 60 weeks ). The same investigators also reported no suggestion of carcinogenicity resulting from five subcutaneous injections of 5 g/kg (given on alternate days for a total dose of 25 g/kg).
An earlier, much smaller study showed a 50% incidence of local sarcomas following subcutaneous injection of methenamine, totaling 25 g/kg, administered over periods of up to 15 months to rats concurrently receiving formic acid. Methenamine hippurate, administered at a dose level of 800 mg/kg/day, did not adversely affect the fertility of female rats. Effects on male fertility have not been adequately studied.
📄 Package Label / Principal Display Panel ▾
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 47781- 577 -01 Methenamine Hippurate Tablets 1g Rx only 100 Tablets