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Methenamine Hippurate 1 g Tablet, 20-count — NDC 59746-0797-65 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Methenamine Hippurate 1 g Tablet, 20-count — NDC 59746-797-65 (Billing 59746-0797-65)

by Jubilant Cadista Pharmaceuticals Inc. · 20 TABLET in 1 BOTTLE

This is a package of 20 tablets of Methenamine Hippurate 1 g Tablet from Jubilant Cadista Pharmaceuticals Inc., marketed since Jan 2023 and currently FDA-listed.

NDC 59746-0797-65
🏷️ FDA NDC (as labeled) 59746-797-65 billing pads the product segment with a zero
This package
Contains20-count Pack sizes2 compare ↓
Also priced by: Part D plans $0.5951/unit — full pricing hub ↓
Product page 59746-0797-01 Also comes in: 100 tablets 59746-797-01
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 59746-797-65
Product NDC 59746-797
11-digit billing NDC 59746079765
RxCUI 992150
UNII M329791L57
UPC 0359746797010
Application # ANDA217675
SPL Set ID 4263d826-7de2-4011-b8ec-ba1f5222f0e6
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-01-24
Route ORAL
Dosage form TABLET
Substance METHENAMINE HIPPURATE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 16800020200305
GCN Seq No 009457
GCN 41980
HICL code 004101
Ingredient (HICL) Methenamine Hippurate
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W2
Therapeutic class — intermediate (HIC2) Antibacterials
HIC3 code W2G
Therapeutic class — specific (HIC3) Antibiotic, Antibacterial, Misc.
AHFS code 08:36.00.00
AHFS class Urinary Anti-Infectives
FDB label name METHENAMINE HIPP 1 GM TABLET
FDB brand name Methenamine Hippurate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • 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
Why two NDCs? The FDA registers this code as 59746-797-65 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 59746-0797-65. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Other antibacterials class.

Drug family (ATC) Other antibacterials
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name METHENAMINE HIPP 1 GM TABLET Ingredient Methenamine Hippurate
📗 Our plain-language guide HelloPharmacist
  • 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?
📖 Read our full Methenamine guide →
7
Nutrient depletion considerations

Methenamine Hippurate may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Methenamine Hippurate nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
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 · Q2 2026 $0.5951 $11.90 / 20 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
59746-0797-01 59746-797-01 Main listing 100 TABLET in 1 BOTTLE $0.3126 / ea $31.26 2023-01-24 — Active
59746-0797-65 You're viewing this 20 TABLET in 1 BOTTLE — — 2023-01-24 — Active

You're viewing the smallest of 2 pack sizes for this product.

This pack shows little to no recent Medicaid volume — the 100 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 20-count package — 20 tablet in 1 bottle.
How does this package differ from NDC 59746-0797-01?
Both are Methenamine Hippurate 1 g Tablet — the drug itself is identical. This page's package is the 20-count one, while NDC 59746-0797-01 is the 100 tablets package.
What NDC number is used to bill for this package of Methenamine Hippurate 1 g Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Methenamine Hippurate 1000 mg 42571-0332-01 Micro 100 tablets $0.313 AB Availability likely —
Methenamine Hippurate 1 g 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 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 gthis 59746-0797-65 Jubilant 20 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 —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2023
On the market since
Jan 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color White
ShapeCapsule
ImprintL;59
Size19 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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 OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • 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 ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII H8AV0SQX4D
    A modified starch derived from potato or corn starch. It absorbs water quickly and helps tablets or capsules break apart and dissolve in the stomach, acting as a disintegrant to ensure the medicine releases its active ingredients properly.

5 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerJubilant Cadista Pharmaceuticals Inc.
Application holderJUBILANT CADISTA PHARMACEUTICALS INC
FDA applicationANDA217675 (ANDA)
Labeler code59746
First marketedJan 2023
Product typeHuman Prescription Drug
Portfolio46 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🧓 Geriatric Use 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 121 words ▾

INDICATIONS Methenamine hippurate tablets, USP is 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 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 95 words ▾

DOSAGE AND 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 g) twice daily (morning and night) for pediatric patients 6 to 12 years of age. Since the antibacterial activity of methenamine hippurate tablets, USP 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 40 words ▾

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 25 words ▾

WARNING 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 43 words ▾

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 Jubilant Cadista Pharmaceuticals Inc. at 1-800-313-4623 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🧓 Geriatric Use 102 words ▾

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, USP are contraindicated in patients with renal insufficiency and severe hepatic insufficiency (see CONTRAINDICATIONS ).

🧬 Mechanism of Action 198 words ▾

ACTIONS Microbiology: Methenamine hippurate tablets has antibacterial activity because the methenamine component is hydrolyzed to formaldehyde in acid urine. Hippuric acid, the other component, has some antibacterial activity and also acts to keep the urine acid. The drug is generally active against E. coli , enterococci and staphylococci.

Enterobacter aerogenes is generally resistant. The urine must be kept sufficiently acid for urea-splitting organisms such as Proteus and Pseudomonas to be inhibited. Susceptibility Testing: For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC.

Human Pharmacology: Within 1/2 hour after ingestion of a single 1-gram dose of methenamine hippurate, antibacterial activity is demonstrable in the urine. Urine has continuous antibacterial activity when methenamine hippurate is administered at the recommended dosage schedule of 1 gram twice daily. Over 90% of methenamine moiety is excreted in the urine within 24 hours after administration of a single 1gram dose.

Similarly, the hippurate moiety is rapidly absorbed and excreted, and it reaches the urine by both tubular secretion and glomerular filtration. This action may be important in older patients or in those with some degree of renal impairment.

📦 How Supplied / Storage and Handling 96 words ▾

HOW SUPPLIED Methenamine Hippurate Tablets USP, 1 g are white to off-white capsule shaped tablet, debossed with “L” and “59” on one side and break line (functional) on other side. Bottle pack of 20 tablets with Child Resistant Closure, NDC 59746-797-65 Bottle pack of 100 tablets with Child Resistant Closure, NDC 59746-797-01 Store at 68° to 77°F (20° to 25°C); excursions permitted to 59° to 86°F (15° to 30°C) [See USP Controlled Room Temperature]. Dispense in well-closed, light-resistant container with child-resistant closure.

Rx Only Marketed by: Jubilant Cadista Pharmaceuticals Inc. Yardley, PA 19067, USA Revision 01/2026

📋 Description 41 words ▾

DESCRIPTION Each white to off-white capsule shaped tablet contains 1g Methenamine Hippurate, USP which is the Hippuric Acid Salt of Methenamine (hexamethylene tetramine). The tablet also contains inactive ingredients colloidal silicon dioxide, microcrystalline cellulose, magnesium stearate, povidone and sodium starch glycolate.

💬 Information for Patients 114 words ▾

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 is 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 217 words ▾

PRECAUTIONS 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, USP 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 is 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 173 words ▾

PRINCIPAL DISPLAY PANEL NDC 59746-797-65 Methenamine Hippurate Tablets, USP 1 gram CADISTA 20 Tablets Rx Only Each Tablet contains: Methenamine Hippurate USP 1g. Usual Dosage: see package insert for dosage information. Warning: Keep out of the reach of children.

Pharmacist: Dispense in well closed, light-resistant container with child-resistant closure. Store at 68° to 77°F (20° to 25°C); excursions permitted to 59° to 86°F (15° to 30°C) [See USP Controlled Room Temperature]. Code: G0/DRUGS/321 Marketed by: Jubilant Cadista Pharmaceuticals Inc.

Yardley, PA 19067, USA Made in India 13015817 NDC 59746-797-01 Methenamine Hippurate Tablets, USP 1 gram CADISTA 100 Tablets Rx Only Each Tablet contains: Methenamine Hippurate USP 1g. Usual Dosage: see package insert for dosage information. Warning: Keep out of the reach of children.

Pharmacist: Dispense in well closed, light-resistant container with child-resistant closure. Store at 68° to 77°F (20° to 25°C); excursions permitted to 59° to 86°F (15° to 30°C) [See USP Controlled Room Temperature]. Code: G0/DRUGS/321 Marketed by: Jubilant Cadista Pharmaceuticals Inc.

Yardley, PA 19067, USA Made in India 13015818 20s 100s

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
100 tablets59746-0797-01 8,284 Rx · $294,723
20 tablets this page59746-0797-65 No Medicaid data
Drug total (last 4 qtrs): 8,284 Rx · 498,010 units · $294,723 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Methenamine Hippurate — the program that covers self-administered drugs. 7 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Methenamine Hippurate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$18.08M
Claims incl. refills
301K
Beneficiaries
166.6K
Spend / beneficiary
$108.53
Spend / claim
$60.07
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Methenamine hippurate — the ingredient across all brands.

Top reported reactions

Urinary Tract Infection163
Diarrhoea81
Nausea80
Fall74
Fatigue74
Headache65
Dizziness60

Age at onset

Adolescent1
Adult57
Elderly170

Reporter sex

1,210 reports
Male · 19%
Female · 81%
Unknown · 0%

Serious outcomes

Hospitalization335
Death75
Disabling29
Life-threatening7
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 129 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Jubilant Cadista Pharmaceuticals Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 100 tablets (59746-0797-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Jubilant Cadista Pharmaceuticals Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 59746-0791-01 · Jubilant 59746-0798-01 · Jubilant →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.