HomeNDC LookupIngredientsGentamicin Sulfate › 61314-0633-05
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Gentamicin Sulfate 3 mg/mL Solution, 5 mL

by Sandoz Inc · 5 mL in 1 BOTTLE, PLASTIC (61314-633-05)
NDC 61314-0633-05
🏷️ FDA NDC (as labeled) 61314-633-05 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 61314-633-05
Product NDC 61314-633
11-digit billing NDC 61314063305
NCPDP billing unit ML — per mL (volume)
RxCUI 310467
UNII 8X7386QRLV
Application # ANDA062196
SPL Set ID a213fb9c-08ea-4f30-a6c9-93c7a9ba5280
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 1996-04-05
Route OPHTHALMIC
Dosage form SOLUTION
Substance GENTAMICIN SULFATE
GPI-14 86101030002005
GPI class Gentamicin Sulfate
GCN Seq No 007984
GCN 33600
HICL code 004032
Ingredient (HICL) Gentamicin Sulfate
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q6
Therapeutic class — intermediate (HIC2) Ophthalmic Preparations
HIC3 code Q6W
Therapeutic class — specific (HIC3) Ophthalmic Antibiotics
AHFS code 08:12.02.00
AHFS class Aminoglycoside Antibiotics
FDB label name GENTAMICIN 0.3% EYE DROP
FDB brand name Gentamicin Sulfate
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AT · RLD · RS
Why two NDCs? The FDA registers this code as 61314-633-05 — 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 → 61314-0633-05. 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.

🏭 Manufacturer & labeler

LabelerSandoz Inc
Application holderSANDOZ INC
FDA applicationANDA062196 (ANDA)
Labeler code61314
First marketedApr 1996
Product typeHuman Prescription Drug
Portfolio387 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.

🩺 Clinical

Label name GENTAMICIN 0.3% EYE DROP Ingredient Gentamicin Sulfate
📗 Our plain-language guide HelloPharmacist
  • Gentamicin eye drops treat bacterial eye infections specifically — things like bacterial conjunctivitis (pink eye), corneal ulcers, and eyelid infections. They won't work against v...
  • What kind of eye infection does this treat — can I use it for any red or irritated eye?
  • The usual dose is one or two drops placed directly into the affected eye every four hours. If your infection is more severe, your doctor may tell you to use two drops every hour. A...
  • Yes, a brief burning or stinging sensation right after applying the drops is the most commonly reported side effect, and it's generally harmless. Some redness or minor irritation i...
📖 Read our full Gentamicin Ophthalmic guide →
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.

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.

🧪 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 F5UM2KM3W7
    Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 22ADO53M6F
    A mineral salt derived from phosphoric acid, used as a buffer to maintain the pH balance of the medication and help stabilize the active ingredients.
  • UNII Y27PUL9H56
    Tyloxapol is a synthetic detergent and surfactant used in medications as a solubilizer and emulsifier. It helps dissolve or blend ingredients that don't naturally mix well, improving how the medicine disperses in liquid formulations.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

7 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 DailyMedingredient 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.

💲 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 mLPer package
Retail pharmacies payNADAC · weekly $0.745 $3.73 / 5 ml
Medicaid paysCMS SDUD · 12 mo $2.02 $10.12 / 5 ml
Medicare drug plans payPart D · Q2 2026 $1.94 $9.69 / 5 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $1.195 $0.590
▲ Up 24% 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Gentamicin Sulfate 3 mg/mL 24208-0580-60 Bausch 1 bottle $0.745 AT Availability likely
Gentamicin Sulfate 3 mg/mLthis 61314-0633-05 Sandoz 5 ml $0.745 AT Availability likely
Gentamicin Sulfate 3 mg/mL 50090-0569-00 A-S 1 bottle AT FDA listed
gentamicin sulfate 3 mg/mL 61919-0106-05 DIRECT 5 ml FDA listed
Gentamicin Sulfate 3 mg/mL 63187-0560-05 Proficient 1 bottle AT FDA listed
Gentamicin Sulfate 3 mg/mL 63187-0764-05 Proficient 1 bottle FDA listed
Gentamicin Sulfate 3 mg/mL 66267-0971-05 NuCare 1 bottle FDA listed
Gentamicin Sulfate 3 mg/mL 68071-3554-05 NuCare 1 bottle AT FDA listed
Gentamicin Sulfate 3 mg/mL 68071-4775-05 NuCare 5 ml AT FDA listed
Gentamicin Sulfate 3 mg/mL 68071-4827-05 NuCare 5 ml FDA listed
Gentamicin Sulfate 3 mg/mL 68788-8592-05 Preferred 1 bottle AT FDA listed
Gentamicin Sulfate 3 mg/mL 71205-0333-05 Proficient 5 ml AT FDA listed
Gentamicin Sulfate Opth Solution 3 mg/mL 72189-0359-05 Direct_Rx 5 ml AT FDA listed
Gentamicin Sulfate 3 mg/mL 76420-0137-05 Asclemed 5 ml AT FDA listed
Gentamicin Sulfate 3 mg/mL 76420-0254-05 Asclemed 1 bottle 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

🏛️
1996
On the market since
Apr 1996
📍
2026
Currently FDA-listed
30 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.

🗺️ 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 61314-0633-05, 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
50.8K
Units reimbursed last 4 qtrs
275.6K
Gross reimbursed last 4 qtrs
$557.6K
Avg / prescription
$10.98
Avg / unit
$2.0231
Latest quarter Q1 2026
11.4KRx
Medicaid pays / mL
$2.0231
gross reimbursed
vs
NADAC / mL
$0.7451
acquisition cost
=
Spread
+$1.2780
+172% vs cost
What Medicaid paid per mL (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
32% FFS 68% MCO
Fee-for-service · 16,465 Rx Managed care · 34,338 Rx
State Medicaid map
Alaska: 245 units · 33.4 per 100k residents AK Maine: no data reported ME Washington: 1,820 units · 23.3 per 100k residents WA Idaho: 580 units · 29.5 per 100k residents ID Montana: 478 units · 42.2 per 100k residents MT North Dakota: 1,145 units · 146 per 100k residents ND Minnesota: 1,431 units · 24.9 per 100k residents MN Wisconsin: 2,085 units · 35.3 per 100k residents WI Michigan: 9,925 units · 98.9 per 100k residents MI New York: 15,230 units · 77.8 per 100k residents NY Vermont: no data reported VT New Hampshire: 295 units · 21.0 per 100k residents NH Oregon: 1,075 units · 25.4 per 100k residents OR Nevada: 3,575 units · 112 per 100k residents NV Wyoming: 335 units · 57.4 per 100k residents WY South Dakota: 531 units · 57.8 per 100k residents SD Iowa: 4,755 units · 148 per 100k residents IA Illinois: 7,565 units · 60.3 per 100k residents IL Indiana: 3,531 units · 51.5 per 100k residents IN Ohio: 9,190 units · 78.0 per 100k residents OH Pennsylvania: 5,525 units · 42.6 per 100k residents PA New Jersey: 4,570 units · 49.2 per 100k residents NJ Massachusetts: 2,051 units · 29.3 per 100k residents MA California: 49,606 units · 127 per 100k residents CA Utah: 400 units · 11.7 per 100k residents UT Colorado: 1,155 units · 19.6 per 100k residents CO Nebraska: 735 units · 37.2 per 100k residents NE Missouri: 2,545 units · 41.1 per 100k residents MO Kentucky: 8,027 units · 177 per 100k residents KY West Virginia: 4,175 units · 236 per 100k residents WV Virginia: 3,715 units · 42.6 per 100k residents VA Maryland: 2,160 units · 35.0 per 100k residents MD Connecticut: 1,815 units · 50.2 per 100k residents CT Rhode Island: 435 units · 39.7 per 100k residents RI Arizona: 6,505 units · 87.5 per 100k residents AZ New Mexico: 2,700 units · 128 per 100k residents NM Kansas: 1,280 units · 43.5 per 100k residents KS Arkansas: 2,145 units · 69.9 per 100k residents AR Tennessee: 280 units · 3.9 per 100k residents TN North Carolina: 6,270 units · 57.9 per 100k residents NC South Carolina: 3,545 units · 66.0 per 100k residents SC Delaware: 285 units · 27.6 per 100k residents DE Oklahoma: 2,905 units · 71.7 per 100k residents OK Louisiana: 7,223 units · 158 per 100k residents LA Mississippi: 5,098 units · 173 per 100k residents MS Alabama: 3,505 units · 68.6 per 100k residents AL Georgia: 8,590 units · 77.9 per 100k residents GA D.C.: 80 units · 11.8 per 100k residents DC Hawaii: 975 units · 67.9 per 100k residents HI Texas: 39,190 units · 128 per 100k residents TX Florida: 15,915 units · 70.4 per 100k residents FL
Units reimbursed · per 100k residents
3.9236
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 West Virginia 236 /100k
2 Kentucky 177 /100k
3 Mississippi 173 /100k
4 Louisiana 158 /100k
5 Iowa 148 /100k
6 North Dakota 146 /100k
7 Texas 128 /100k
8 New Mexico 128 /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.

📊 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.

🔬 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 GENTAMICIN SULFATE — the ingredient across all brands.

Top reported reactions

Acute Kidney Injury1,204
Pyrexia896
Renal Failure705
Diarrhoea562
Sepsis508
Condition Aggravated504
Hypotension493

Reporter sex

15,711 reports

Serious outcomes

Death2,828
Life-threatening1,944
Disabling628
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,140 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
61314-0633-05 You're viewing this 5 mL in 1 BOTTLE, PLASTIC (61314-633-05) 1996-04-05 Active

📄 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 60 words

INDICATIONS AND USAGE Gentamicin Sulfate Ophthalmic Solution is indicated in the topical treatment of ocular bacterial infections, including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.

⏱️ Dosage and Administration 31 words

DOSAGE AND ADMINISTRATION Instill one or two drops into the affected eye(s) every four hours. In severe infections, dosage may be increased to as much as two drops once every hour.

Contraindications 17 words

CONTRAINDICATIONS Gentamicin Sulfate Ophthalmic Solution is contraindicated in patients with known hypersensitivity to any of the components.

⚠️ Warnings 34 words

WARNINGS NOT FOR INJECTION INTO THE EYE. Gentamicin Sulfate Ophthalmic Solution is not for injection. It should never be injected subconjunctivally, nor should it be directly introduced into the anterior chamber of the eye.

🤒 Adverse Reactions 67 words

ADVERSE REACTIONS Bacterial and fungal corneal ulcers have developed during treatment with gentamicin ophthalmic preparations. The most frequently reported adverse reactions are ocular burning and irritation upon drug instillation, non-specific conjunctivitis, conjunctival epithelial defects, and conjunctival hyperemia. Other adverse reactions which have occurred rarely are allergic reactions, thrombocytopenic purpura, and hallucinations.

To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🤰 Pregnancy 64 words

Pregnancy Gentamicin has been shown to depress body weights, kidney weights, and median glomerular counts in newborn rats when administered systemically to pregnant rats in daily doses approximately 500 times the maximum recommended ophthalmic human dose. There are no adequate and well-controlled studies in pregnant women. Gentamicin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use 11 words

Pediatric Use Safety and effectiveness in neonates have not been established.

🧬 Clinical Pharmacology 39 words

CLINICAL PHARMACOLOGY Microbiology: Gentamicin sulfate is active in vitro against many strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.

📦 How Supplied / Storage and Handling 56 words

HOW SUPPLIED Gentamicin Sulfate Ophthalmic Solution is supplied sterile, in a natural LDPE plastic bottle with a natural LDPE dropper tip and a white polypropylene cap as follows: NDC 61314-633-05 - 5mL filled in 8mL bottle. STORAGE Store at controlled room temperature 15° to 25°C (59° to 77°F). Protect from light and store away from heat.

📋 Description 132 words

DESCRIPTION Gentamicin Sulfate is a water-soluble antibiotic of the aminoglycoside group. Gentamicin Sulfate Ophthalmic Solution is a sterile, aqueous solution buffered to approximately pH 7 for ophthalmic use. Gentamicin is obtained from cultures of Micromonospora purpurea .

It is a mixture of the sulfate salts of gentamicin C 1 , C 2 , and C 1A . All three components appear to have similar antimicrobial activities. Gentamicin sulfate occurs as white powder and is soluble in water and insoluble in alcohol.

The structure is as follows: Established name: Gentamicin Sulfate Chemical name: 0-3-Deoxy-4-C-methyl-3-(methylamino)-β-L-arabinopyranosyl-(1→6)-0-[2,6-diamino-2,3,4,6-tetradeoxy-α-D-erythro-hexopyranosyl-(1→4)]-2-deoxy-D-streptamine. Ingredients: Each mL contains: Active: Gentamicin Sulfate USP (equivalent to 3 mg gentamicin). Preservative: Benzalkonium Chloride 0.1 mg (0.01%).

Inactives: Dibasic Sodium Phosphate Anhydrous, Sodium Chloride, Sodium Hydroxide and/or Hydrochloric Acid (to adjust pH), Tyloxapol and Purified Water. chemicalstructure

💬 Information for Patients 19 words

Information for Patients To avoid contamination, do not touch tip of container to the eye, eyelid, or any surface.

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