Methenamine Hippurate 1 g Tablet, 100-count — NDC 70954-959-10 (Billing 70954-0959-10)
This is a package of 100 tablets of Methenamine Hippurate 1 g Tablet from ANI Pharmaceuticals, Inc., marketed since Jul 2026 and currently FDA-listed; 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 70954-959-10 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 70954 labeler · 959 product · 10 package
- Package marketed since
- Jul 27, 2026
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Billing quantity
- 100 EA per package
- Barcode (UPC)
- 0370954959106
- FDA record last changed
- Sep 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
- RxCUI (RxNorm): 992150
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 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
Methenamine, an antibiotic, eliminates bacteria that cause urinary tract infections. It usually is used on a long-term basis to treat chronic infections and to prevent recurrence of infections. Antibiotics will not work for colds, flu, or other viral infections. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Read the full MedlinePlus article ↗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 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 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 | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 8, 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 |
|---|---|---|---|---|
| 70954-0959-10 You're viewing this Main listing | 100 TABLET in 1 BOTTLE | 2026-07-27 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| 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 1 g 72578-0175-01 | Viona | 100 tablets | $0.313 | AB | Availability likely | — |
| Methenamine Hippurate 1 g 47781-0577-01 | Alvogen | 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 65862-0782-01 | Aurobindo | 100 tablets | $0.313 | AB | Availability likely | — |
| Methenamine Hippurate 1 gthis 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 70771-1919-01 | Zydus | 100 tablets | — | AB | FDA listed | — |
| Methenamine Hippurate 1 g 70685-0050-01 | Esjay | 100 tablets | — | AB | Discontinued | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Oct 7, 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
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 8, 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 I753WB2F1M
FD&C Yellow No. 5 is a synthetic yellow colorant approved by the FDA. It is added to medicines to make pills, tablets, or liquids visually distinct and easier to identify.
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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.
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UNII U725QWY32X
Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
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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.
4 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 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 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 ANI Pharmaceuticals, Inc. labeler code 70954
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- Bromocriptine Mesylate 5 mg Capsule NDC 70954-951-10
- Sacubitril and Valsartan 24 mg; 26 mg Tablet, Film Coated NDC 70954-975-20
- Sacubitril and Valsartan 49 mg; 51 mg Tablet, Film Coated NDC 70954-976-20
- Sacubitril and Valsartan 97 mg; 103 mg Tablet, Film Coated NDC 70954-977-20
- Bromocriptine Mesylate 2.5 mg Tablet NDC 70954-978-10
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS & USAGE 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. 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.
⏱️ Dosage and Administration ▾
DOSAGE & ADMINISTRATION 1 tablet (1.0 g) twice daily (morning and night) for adults and pediatric patients over 12 years of age. 1/2 to 1 tablet (0.5 to 1.0 g) twice daily (morning and night) for pediatric patients 6 to 12 years of age. Since the antibacterial activity of methenamine hippurate tablets is greater in acid urine, restriction of alkalinizing foods and medications is desirable.
If necessary, as indicated by urinary pH and clinical response, supplemental acidification of the urine should 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. Methenamine preparations should not be given to patients taking sulfonamides because some sulfonamides may form an insoluble precipitate with formaldehyde in the urine.
⚠️ Warnings ▾
WARNINGS Large doses of methenamine (8 grams daily for 3 to 4 weeks) have caused bladder irritation, painful and frequent micturition, albuminuria, and gross hematuria.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Minor adverse reactions have been reported in less than 3.5% of patients treated. These reactions have included nausea, upset stomach, dysuria, and rash. To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🧓 Geriatric Use ▾
GERIATRIC USE Clinical studies of methenamine hippurate tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
Methenamine hippurate tablets are contraindicated in patients with renal insufficiency and severe hepatic insufficiency ( see CONTRAINDICATIONS ).
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED 1 gram - Yellow, capsule shaped tablet debossed with E50 on one side and scored on other side, available in bottles of 100 (NDC 70954-959-10). Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Dispense in well-closed, light-resistant container with child-resistant closure.
Manufactured by: Esjay Pharma Private Limited, Sipcot Industrial Park, Kanchipuram, Tamilnadu, India – 602117 Distributed by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 P3337/00/25 Rev. 05/2025
📋 Description ▾
DESCRIPTION Each yellow, capsule-shaped tablet contains 1 g Methenamine Hippurate, USP which is the hippuric acid salt of methenamine (hexamethylene tetramine). The tablet also contains inactive ingredients: FD&C Yellow No. 5 (tartrazine, see PRECAUTIONS ), magnesium stearate, povidone, and saccharin sodium.
💬 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 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. Care should be taken to maintain an acid pH of the urine, especially when treating infections due to urea-splitting organisms such as Proteus and strains of Pseudomonas . In a few instances in one study, the serum transaminase levels were slightly elevated during treatment but returned to normal while the patients were still taking methenamine hippurate tablets.
Because of this report, it is recommended that liver function studies be performed periodically on patients taking the drug, especially those with liver dysfunction. Use in Pregnancy: In early pregnancy the safe use of methenamine hippurate tablets is not established. In the last trimester, safety is suggested, but not definitely proved.
No adverse effects on the fetus were seen in studies in pregnant rats and rabbits. Methenamine hippurate tablets taken during pregnancy can interfere with laboratory tests of urine estriol (resulting in unmeasurably low values) when acid hydrolysis is used in the laboratory procedure. This interference is due to the presence in the urine of methenamine and/or formaldehyde.
Enzymatic hydrolysis, in place of acid hydrolysis, will circumvent this problem. This product contains FD&C Yellow No. 5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals.
Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. GERIATRIC USE Clinical studies of methenamine hippurate tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. Methenamine hippurate tablets are contraindicated in patients with renal insufficiency and severe hepatic insufficiency ( see CONTRAINDICATIONS ).
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.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Container Label NDC 70954-959-10 label