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Gentamicin Sulfate 1 mg/g Ointment — NDC 45802-0046-11 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Gentamicin Sulfate 1 mg/g Ointment — NDC 45802-046-11 (Billing 45802-0046-11)

by Padagis Israel Pharmaceuticals Ltd · 1 TUBE in 1 CARTON / 30 g in 1 TUBE

This is a package of Gentamicin Sulfate 1 mg/g Ointment from Padagis Israel Pharmaceuticals Ltd, marketed since Jul 2006 and currently FDA-listed; retail pharmacies pay about $0.7705 per g (NADAC).

NDC 45802-0046-11
🏷️ FDA NDC (as labeled) 45802-046-11 billing pads the product segment with a zero
This package
Contains30 g in 1 tube Cost per g$0.7705 NADAC Per package$23.12 / 30 g Pack sizes2 compare ↓
Also priced by: Medicaid pays $1.10/unit · Part D plans $1.44/unit — full pricing hub ↓
Product page 45802-0046-35 Also comes in: 15 g 45802-046-35
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) 45802-046-11
Product NDC 45802-046
11-digit billing NDC 45802004611
NCPDP billing unit GM — per gram (weight)
RxCUI 310465
UNII 8X7386QRLV
Application # ANDA062351
SPL Set ID a9486ae1-350b-41c5-ae0c-a4d692bb2dfd
Established class (EPC) Aminoglycoside Antibacterial
Chemical class Aminoglycosides
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2006-07-10
Route TOPICAL
Dosage form OINTMENT
Substance GENTAMICIN SULFATE
TE code (Orange Book) AT · RLD · RS

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

GPI-14 90100050104205
GPI class Gentamicin Sulfate
GCN Seq No 007725
GCN 31800
HICL code 004032
Ingredient (HICL) Gentamicin Sulfate
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 Q5W
Therapeutic class — specific (HIC3) Topical Antibiotics
AHFS code 08:12.02.00
AHFS class Aminoglycoside Antibiotics
FDB label name GENTAMICIN 0.1% OINTMENT
FDB brand name Gentamicin Sulfate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 007725
  • GCN: 31800
  • GPI-14 (Medi-Span): 90100050104205
  • HICL (First Databank): 004032
  • AHFS class code: 08:12.02.00
  • RxCUI (RxNorm): 310465
Why two NDCs? The FDA registers this code as 45802-046-11 — 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 → 45802-0046-11. 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 Aminoglycoside Antibacterial class.

Pharmacologic class Aminoglycoside Antibacterial
Drug family (ATC) Other antibiotics for topical use, Other aminoglycosides, Antibiotics
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 GENTAMICIN 0.1% OINTMENT Ingredient Gentamicin Sulfate
📖 What it is MedlinePlus · NLM

Topical gentamicin is used in adults and children 1 year of age and older to treat skin infections caused by certain bacteria. Topical gentamicin is in a class of medications called antibiotics. It works by killing bacteria that cause infections.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Gentamicin topical is used for a wide range of bacterial skin infections. That includes common ones like impetigo, boils, infected eczema, infected cuts or scrapes, pustular acne,...
  • What kinds of skin infections does gentamicin topical actually treat?
  • It depends on the type of skin involved. The cream is better for wet, oozy infections or greasy conditions like infected seborrheic dermatitis or pustular acne — and it's also easi...
  • Apply a small amount to the affected area three to four times a day. You can cover it with a gauze dressing afterward if you'd like. If you're treating impetigo, gently remove any...
📖 Read our full Gentamicin Topical guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
8
Nutrient depletion considerations

Gentamicin (IV) may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Gentamicin (IV) 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 gPer package
Retail pharmacies payNADAC · weekly $0.771 $23.12 / 30 g
Medicaid paysCMS SDUD · 12 mo $1.10 $33.00 / 30 g
Medicare drug plans payPart D · Q2 2026 $1.44 $43.25 / 30 g
NADAC price history (per g) — tap or hover for the price & month
Dec 2021 Aug 2022 Jan 2026 Sep 2026 $1.421 $0.726
▼ Down 40% over the last 24 months.
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
45802-0046-11 You're viewing this 1 TUBE in 1 CARTON / 30 g in 1 TUBE $0.7705 / g $23.12 2006-08-28 — Active
45802-0046-35 45802-046-35 Main listing 1 TUBE in 1 CARTON / 15 g in 1 TUBE $0.9407 / g $14.11 2006-07-10 — Active

This pack has the lowest per-g cost of the 2 priced pack sizes ($0.7705 NADAC).

This pack accounts for about 31% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 carton / 30 g in 1 tube.
What NDC number is used to bill for this package of Gentamicin Sulfate 1 mg/g Ointment?
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
Gentamicin Sulfate 1 mg/gthis 45802-0046-11 Padagis 1 tube $0.771 AT Availability likely —
Gentamicin Sulfate 1 mg/g 00713-0683-15 Cosette 1 tube $0.884 AT Availability likely +15%
Gentamicin Sulfate 1 mg/g 45802-0056-11 Padagis 1 tube $0.887 AT Availability likely +15%
Gentamicin Sulfate 1 mg/g 00713-0682-15 Cosette 1 tube $0.941 AT Availability likely +22%
Gentamicin Sulfate 1 mg/g 71205-0560-15 Proficient 1 tube — AT 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

🏛️
2006
On the market since
Jul 2006
📍
2026
Currently FDA-listed
20 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.

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 N6K5787QVP
    Light mineral oil is a clear, odorless liquid derived from petroleum. In medicines, it acts as a lubricant and emollient to help the product spread smoothly and improve texture.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.

4 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

LabelerPadagis Israel Pharmaceuticals Ltd
Application holderPADAGIS US LLC
FDA applicationANDA062351 (ANDA)
Labeler code45802
First marketedJul 2006
Product typeHuman Prescription Drug
Portfolio175 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 🤒 Adverse Reactions 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~1 min read ▾

INDICATIONS AND USAGE Primary skin infections: Impetigo contagiosa, superficial folliculitis, ecthyma, furunculosis, sycosis barbae, and pyoderma gangrenosum. Secondary skin infections: Infectious eczematoid dermatitis, pustular acne, pustular psoriasis, infected seborrheic dermatitis, infected contact dermatitis (including poison ivy), infected excoriations, and bacterial superinfections of fungal or viral infections. NOTE: Gentamicin Sulfate is a bactericidal agent that is not effective against viruses or fungi in skin infections.

It is useful in the treatment of infected skin cysts and certain other skin abscesses when preceded by incision and drainage to permit adequate contact between the antibiotic and the infecting bacteria. Good results have been obtained in the treatment of infected stasis and other skin ulcers, infected superficial burns, paronychia, infected insect bites and stings, infected lacerations and abrasions and wounds from minor surgery. Patients sensitive to neomycin can be treated with Gentamicin Sulfate, although regular observation of patients sensitive to topical antibiotics is advisable when such patients are treated with any topical antibiotic.

Gentamicin sulfate cream is recommended for wet, oozing primary infections, and greasy, secondary infections, such as postular acne or infected seborrheic dermatitis. Gentamicin Sulfate Ointment USP, 0.1% helps retain moisture and has been useful in infection on dry eczematous or psoriatic skin. Gentamicin Sulfate Ointment USP, 0.1% has been used successfully in infants over one year of age as well as in adults and children.

⏱️ Dosage and Administration 86 words ▾

DOSAGE AND ADMINISTRATION A small amount of Gentamicin Sulfate Ointment USP, 0.1% should be applied gently to lesions three to four times a day. The area treated may be covered with a gauze dressing, if desired. In impetigo contagiosa, the crusts should be removed before application of Gentamicin Sulfate Ointment USP, 0.1% to permit maximum contact between the antibiotic and the infection.

Care should be exercised to avoid further contamination of the infected skin. Infected stasis ulcers have responded well to Gentamicin Sulfate under gelatin packing.

⛔ Contraindications 21 words ▾

CONTRAINDICATIONS Gentamicin Sulfate Ointment USP, 0.1% is contraindicated in individuals with a history of sensitivity reactions to any of its components.

🤒 Adverse Reactions 78 words ▾

ADVERSE REACTIONS In patients with dermatoses treated with Gentamicin Sulfate, irritation (erythema and pruritus) that did not usually require discontinuance of treatment has been reported in a small percentage of cases. There was no evidence of irritation or sensitization, however, in any of these patients patch-tested subsequently with gentamicin on normal skin. Possible photosensitization has been reported in several patients but could not be elicited in these patients by reapplication of gentamicin followed by exposure to ultraviolet radiation.

🧬 Clinical Pharmacology 124 words ▾

CLINICAL PHARMACOLOGY Gentamicin Sulfate is a wide spectrum antibiotic that provides highly effective topical treatment in primary and secondary bacterial infections of the skin. This product may clear infections that have not responded to other topical antibiotic agents. In impetigo contagiosa and other primary skin infections, treatment with a small amount of Gentamicin Sulfate Ointment three to four times daily usually clears the lesions promptly.

In secondary skin infections, the product facilitates the treatment of the underlying dermatosis by controlling the infection. Bacteria susceptible to the action of Gentamicin Sulfate include sensitive strains of Streptococci (group A beta-hemolytic, alpha-hemolytic), Staphylococcus aureus (coagulase positive, coagulase negative, and some penicillinase-producing strains), and the gram-negative bacteria, Pseudomonas aeruginosa, Aerobacter aerogens, Escherichia coli, Proteus vulgaris and Klebsiella pneumoniae.

📦 How Supplied / Storage and Handling 25 words ▾

HOW SUPPLIED Gentamicin Sulfate Ointment USP, 0.1% is available as follows: 15 g tube (NDC 45802- 046 -35) 30 g tube (NDC 45802- 046 -11)

📦 Storage and Handling 10 words ▾

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

📋 Description 54 words ▾

DESCRIPTION Gentamicin Sulfate Ointment USP, 0.1% is a wide spectrum antibiotic preparation for topical administration. Each gram of Gentamicin Sulfate Ointment USP, 0.1% contains Gentamicin Sulfate USP equivalent to 1 mg of gentamicin base in a base of light mineral oil and white petrolatum, with 0.5 mg methylparaben and 0.1 mg propylparaben as preservatives.

⚠️ Precautions 37 words ▾

PRECAUTIONS Use of topical antibiotics occasionally allows overgrowth of nonsusceptible organisms, including fungi. If this occurs, or if irritation, sensitization, or superinfection develops, treatment with Gentamicin Sulfate Ointment USP, 0.1% should be discontinued and appropriate therapy instituted.

📄 Package Label / Principal Display Panel 49 words ▾

Principal Display Panel - Carton NDC 45802-046-35 Rx Only Gentamicin Sulfate Ointment USP, 0.1% NET WT 15 g The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation. Gentamycin Sulfate Ointment USP carton serialization-template.jpg

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
2K
Units reimbursed last 4 qtrs
65.6K
Gross reimbursed last 4 qtrs
$72.2K
Avg / prescription
$35.46
Avg / unit
$1.0999
Latest quarter Q1 2026
1.3KRx
Medicaid pays / g
$1.0999
gross reimbursed
vs
NADAC / g
$0.7705
acquisition cost
=
Spread
+$0.3294
+43% vs cost
What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
92% FFS
Fee-for-service · 1,863 Rx Managed care · 173 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 2,505 units · 25.0 per 100k residents MI New York: 23,580 units · 120 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 450 units · 3.6 per 100k residents IL Indiana: 1,830 units · 26.7 per 100k residents IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: 345 units · 3.7 per 100k residents NJ Massachusetts: no data reported MA California: 33,600 units · 86.2 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 330 units · 5.3 per 100k residents MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: 840 units · 23.2 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 2,160 units · 9.6 per 100k residents FL
Units reimbursed · per 100k residents
3.6120
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 120 /100k
2 California 86.2 /100k
3 Indiana 26.7 /100k
4 Michigan 25.0 /100k
5 Connecticut 23.2 /100k
6 Florida 9.6 /100k
7 Missouri 5.3 /100k
8 New Jersey 3.7 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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 tube45802-0046-35 4,623 Rx · $156,276
1 tube this page45802-0046-11 2,036 Rx · $72,197
Drug total (last 4 qtrs): 6,659 Rx · 184,880 units · $228,473 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 Gentamicin Sulfate — the program that covers self-administered drugs. 10 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 Gentamicin Sulfate. 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
$3.25M
Claims incl. refills
100.3K
Beneficiaries
78.4K
Spend / beneficiary
$41.48
Spend / claim
$32.41
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.
← 45802-0045-01 · Padagis 45802-0048-11 · Padagis →
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.