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Naftifine Hydrochloride 10 mg/g Cream — NDC 51672-1362-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Naftifine Hydrochloride 10 mg/g Cream — NDC 51672-1362-1 (Billing 51672-1362-01)

by Sun Pharmaceutical Industries, Inc. · 1 TUBE in 1 CARTON / 15 g in 1 TUBE

This is a package of Naftifine Hydrochloride 10 mg/g Cream from Sun Pharmaceutical Industries, Inc., marketed since Sep 2016 and currently FDA-listed.

NDC 51672-1362-01
🏷️ FDA NDC (as labeled) 51672-1362-1 billing pads the package segment with a zero
This package
Contains15 g in 1 tube Pack sizes4 compare ↓
Also priced by: Part D plans $3.52/unit — full pricing hub ↓
Product page 51672-1362-03 Also comes in: 30 g 51672-1362-2 60 g 51672-1362-3 90 g 51672-1362-8
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) 51672-1362-1
Product NDC 51672-1362
11-digit billing NDC 51672136201
RxCUI 896110
UNII 25UR9N9041
Application # ANDA205975
SPL Set ID d50961c2-e97f-4583-91d6-7cafd25a8c3d
Established class (EPC) Allylamine Antifungal
Chemical class Allylamine
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-09-08
Route TOPICAL
Dosage form CREAM
Substance NAFTIFINE HYDROCHLORIDE

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

GPI-14 90150078003710
GPI class Naftifine HCl
GCN Seq No 007374
GCN 47770
HICL code 003204
Ingredient (HICL) Naftifine Hcl
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5F
Therapeutic class — specific (HIC3) Topical Antifungals
AHFS code 84:04.08.04
AHFS class Allylamines (Skin And Mucous Membrane)
FDB label name NAFTIFINE HCL 1% CREAM
FDB brand name Naftifine Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 007374
  • GCN: 47770
  • GPI-14 (Medi-Span): 90150078003710
  • HICL (First Databank): 003204
  • AHFS class code: 84:04.08.04
  • RxCUI (RxNorm): 896110
Why two NDCs? The FDA registers this code as 51672-1362-1 — a 5-4-1 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 package segment → 51672-1362-01. 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 Allylamine Antifungal class.

Pharmacologic class Allylamine Antifungal
Drug family (ATC) Other antifungals for topical use
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 NAFTIFINE HCL 1% CREAM Ingredient Naftifine Hcl
📖 What it is MedlinePlus · NLM

Naftifine is used for skin infections such as athlete's foot, jock itch, and ringworm. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • The gel treats athlete's foot between the toes (interdigital tinea pedis). It works against the fungi that commonly cause this infection.
  • Apply a thin layer once a day to the infected skin and a small margin of healthy skin around it. Keep going for 2 weeks. It is only for the skin, so keep it out of your eyes, mouth...
  • Itching is the most common one. Some people notice redness, irritation or burning. Most reactions are mild.
  • Stop and call your doctor if redness, irritation or sensitivity develops. Also call if you notice blisters, crusting or fluid draining from the skin.
📖 Read our full Naftifine Topical guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 gPer 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 $3.52 $52.79 / 15 g
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
51672-1362-01 You're viewing this 1 TUBE in 1 CARTON / 15 g in 1 TUBE — — 2016-09-08 — Active
51672-1362-02 51672-1362-2 1 TUBE in 1 CARTON / 30 g in 1 TUBE — — 2016-09-08 — Active
51672-1362-03 51672-1362-3 Main listing 1 TUBE in 1 CARTON / 60 g in 1 TUBE $4.19 / g $251.57 2016-09-08 — Active
51672-1362-08 51672-1362-8 1 TUBE in 1 CARTON / 90 g in 1 TUBE — — 2016-09-08 — Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 carton / 15 g in 1 tube.
What NDC number is used to bill for this package of Naftifine Hydrochloride 10 mg/g Cream?
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
Naftifine Hydrochloride 10 mg/gthis 51672-1362-01 Sun 1 tube — — 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

🏛️
2016
On the market since
Sep 2016
📍
2026
Currently FDA-listed
10 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
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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerSun Pharmaceutical Industries, Inc.
Application holderSUN PHARMA CANADA INC
FDA applicationANDA205975 (ANDA)
Labeler code51672
First marketedSep 2016
Product typeHuman Prescription Drug
Portfolio890 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 🤰 Pregnancy 🧒 Pediatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 34 words ▾

INDICATIONS AND USAGE Naftifine Hydrochloride Cream USP, 1% is indicated for the topical treatment of tinea pedis, tinea cruris and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum .

⏱️ Dosage and Administration 55 words ▾

DOSAGE AND ADMINISTRATION A sufficient quantity of Naftifine Hydrochloride Cream USP, 1% should be gently massaged into the affected and surrounding skin areas once a day. The hands should be washed after application. If no clinical improvement is seen after four weeks of treatment with Naftifine Hydrochloride Cream USP, 1%, the patient should be re-evaluated.

⛔ Contraindications 19 words ▾

CONTRAINDICATIONS Naftifine Hydrochloride Cream USP, 1% is contraindicated in individuals who have shown hypersensitivity to any of its components.

⚠️ Warnings 16 words ▾

WARNINGS Naftifine Hydrochloride Cream USP, 1% is for topical use only and not for ophthalmic use.

🤒 Adverse Reactions 30 words ▾

ADVERSE REACTIONS During clinical trials with Naftifine Hydrochloride Cream USP, 1%, the incidence of adverse reactions was as follows: burning/stinging (6%), dryness (3%), erythema (2%), itching (2%), local irritation (2%).

🤰 Pregnancy 75 words ▾

Pregnancy Teratogenic Effects Reproduction studies have been performed in rats and rabbits (via oral administration) at doses 150 times or more than the topical human dose and have revealed no evidence of impaired fertility or harm to the fetus due to naftifine. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

🧒 Pediatric Use 12 words ▾

Pediatric use Safety and effectiveness in pediatric patients have not been established.

🧬 Clinical Pharmacology 208 words ▾

CLINICAL PHARMACOLOGY Naftifine hydrochloride is a synthetic allylamine derivative. The following in vitro data are available, but their clinical significance is unknown. Naftifine hydrochloride has been shown to exhibit fungicidal activity in vitro against a broad spectrum of organisms, including Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Epidermophyton floccosum, Microsporum canis, Microsporum audouini, and Microsporum gypseum; and fungistatic activity against Candida species, including Candida albicans .

Naftifine Hydrochloride Cream USP, 1% has only been shown to be clinically effective against the disease entities listed in the INDICATIONS AND USAGE section. Although the exact mechanism of action against fungi is not known, naftifine hydrochloride appears to interfere with sterol biosynthesis by inhibiting the enzyme squalene 2, 3-epoxidase. This inhibition of enzyme activity results in decreased amounts of sterols, especially ergosterol, and a corresponding accumulation of squalene in the cells.

Pharmacokinetics In vitro and in vivo bioavailability studies have demonstrated that naftifine penetrates the stratum corneum in sufficient concentration to inhibit the growth of dermatophytes. Following a single topical application of 1% naftifine cream to the skin of healthy subjects, systemic absorption of naftifine was approximately 6% of the applied dose. Naftifine and/or its metabolites are excreted via the urine and feces with a half-life of approximately two to three days.

📦 How Supplied / Storage and Handling 50 words ▾

HOW SUPPLIED Naftifine Hydrochloride Cream USP, 1% is supplied in the following sizes: 15 g - NDC 51672-1362-1 (tube) 30 g - NDC 51672-1362-2 (tube) 60 g - NDC 51672-1362-3 (tube) 90 g - NDC 51672-1362-8 (tube) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

📦 Storage and Handling 13 words ▾

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

📋 Description 88 words ▾

DESCRIPTION Naftifine Hydrochloride Cream USP, 1% contains the synthetic, broad-spectrum, antifungal agent naftifine hydrochloride. Naftifine Hydrochloride Cream USP, 1% is for topical use only. CHEMICAL NAME: (E)-N-Cinnamyl-N-methyl-1-naphthalenemethylamine hydrochloride.

Naftifine hydrochloride has an empirical formula of C 21 H 21 N∙HCl and a molecular weight of 323.86. Structural Formula naftifine hydrochloride Contains Active Ingredient Naftifine hydrochloride 1% Inactive Ingredients benzyl alcohol, cetyl alcohol, cetyl esters wax, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, and stearyl alcohol. Hydrochloric acid may be added to adjust pH.

Chemical Structure

💬 Information for Patients 39 words ▾

Information for patients The patient should be told to: Avoid the use of occlusive dressings or wrappings unless otherwise directed by the physician. Keep Naftifine Hydrochloride Cream USP, 1% away from the eyes, nose, mouth and other mucous membranes.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General Naftifine Hydrochloride Cream USP, 1% is for external use only. If irritation or sensitivity develops with the use of Naftifine Hydrochloride Cream USP, 1%, treatment should be discontinued and appropriate therapy instituted. Diagnosis of the disease should be confirmed either by direct microscopic examination of a mounting of infected tissue in a solution of potassium hydroxide or by culture on an appropriate medium.

Information for patients The patient should be told to: Avoid the use of occlusive dressings or wrappings unless otherwise directed by the physician. Keep Naftifine Hydrochloride Cream USP, 1% away from the eyes, nose, mouth and other mucous membranes. Carcinogenesis, mutagenesis, impairment of fertility In a 2-year dermal carcinogenicity study, naftifine hydrochloride cream was administered to Sprague-Dawley rats at topical doses of 1%, 2% and 3% (10 mg/kg/day, 20 mg/kg/day, and 30 mg/kg/day naftifine hydrochloride).

No drug-related tumors were noted in this study up to the highest dose evaluated in this study of 30 mg/kg/day [3.6 times the maximum recommended human dose (MRHD) based on mg/m 2 comparison]. Naftifine hydrochloride revealed no evidence of mutagenic or clastogenic potential based on the results of two in vitro genotoxicity tests (Ames assay and Chinese hamster ovary cell chromosome aberration assay) and one in vivo genotoxicity test (mouse bone marrow micronucleus assay). Oral administration of naftifine hydrochloride to rats, throughout mating, gestation, parturition and lactation, demonstrated no effects on growth, fertility or reproduction, at doses up to 100 mg/kg/day (12 times MRHD based on mg/m 2 comparison).

Pregnancy Teratogenic Effects Reproduction studies have been performed in rats and rabbits (via oral administration) at doses 150 times or more than the topical human dose and have revealed no evidence of impaired fertility or harm to the fetus due to naftifine. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Naftifine Hydrochloride Cream USP, 1% is administered to a nursing woman. Pediatric use Safety and effectiveness in pediatric patients have not been established.

🍼 Nursing Mothers 38 words ▾

Nursing mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Naftifine Hydrochloride Cream USP, 1% is administered to a nursing woman.

🧬 Pharmacokinetics 71 words ▾

Pharmacokinetics In vitro and in vivo bioavailability studies have demonstrated that naftifine penetrates the stratum corneum in sufficient concentration to inhibit the growth of dermatophytes. Following a single topical application of 1% naftifine cream to the skin of healthy subjects, systemic absorption of naftifine was approximately 6% of the applied dose. Naftifine and/or its metabolites are excreted via the urine and feces with a half-life of approximately two to three days.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 145 words ▾

Carcinogenesis, mutagenesis, impairment of fertility In a 2-year dermal carcinogenicity study, naftifine hydrochloride cream was administered to Sprague-Dawley rats at topical doses of 1%, 2% and 3% (10 mg/kg/day, 20 mg/kg/day, and 30 mg/kg/day naftifine hydrochloride). No drug-related tumors were noted in this study up to the highest dose evaluated in this study of 30 mg/kg/day [3.6 times the maximum recommended human dose (MRHD) based on mg/m 2 comparison]. Naftifine hydrochloride revealed no evidence of mutagenic or clastogenic potential based on the results of two in vitro genotoxicity tests (Ames assay and Chinese hamster ovary cell chromosome aberration assay) and one in vivo genotoxicity test (mouse bone marrow micronucleus assay).

Oral administration of naftifine hydrochloride to rats, throughout mating, gestation, parturition and lactation, demonstrated no effects on growth, fertility or reproduction, at doses up to 100 mg/kg/day (12 times MRHD based on mg/m 2 comparison).

📄 Package Label / Principal Display Panel 47 words ▾

PRINCIPAL DISPLAY PANEL - 90 g Tube Carton NDC 51672-1362-8 90 g Naftifine Hydrochloride Cream USP, 1% FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx only TARO Keep this and all medications out of the reach of children. Principal Display Panel - 90 g Tube Carton

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.
1 tube51672-1362-03 445 Rx · $206,973
1 tube51672-1362-08 11 Rx · $2,837
1 tube this page51672-1362-01 No Medicaid data
1 tube51672-1362-02 No Medicaid data
Drug total (last 4 qtrs): 456 Rx · 45,750 units · $209,810 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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 Naftifine Hydrochloride — the ingredient across all brands.

Top reported reactions

Pruritus33
Blister27
Skin Exfoliation26
Hypersensitivity25
Chronic Kidney Disease24
Rash23
Erythema21

Age at onset

Adolescent1
Adult20
Elderly17

Reporter sex

0 reports
Male · 50%
Female · 50%
Unknown · 0%

Serious outcomes

Hospitalization68
Death12
Disabling10
Life-threatening4
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 33 5
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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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 Sun Pharmaceutical Industries, 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 3 other package presentations of this same product, including 1 tube (51672-1362-02), 1 tube (51672-1362-03), 1 tube (51672-1362-08). 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?
Sun Pharmaceutical Industries, 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.
← 51672-1361-05 · Sun 51672-1363-03 · Sun →
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.