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Elimite permethrin 50 mg/g Cream — NDC 59651-834-60 (Billing 59651-0834-60)

by Aurobindo Pharma Limited · 1 TUBE in 1 CARTON / 60 g in 1 TUBE

This is a package of Elimite permethrin 50 mg/g Cream from Aurobindo Pharma Limited, marketed since Jan 2024 and currently FDA-listed. It is this product's only package size.

NDC 59651-0834-60
🏷️ FDA NDC (as labeled) 59651-834-60 billing pads the product segment with a zero
Rx only Brand 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) 59651-834-60
Product NDC 59651-834
11-digit billing NDC 59651083460
NCPDP billing unit GM — per gram (weight)
RxCUI 106387, 207485
UNII 509F88P9SZ
UPC 0359651834602
Application # NDA019855
SPL Set ID 443c0446-ccba-4f52-83ed-4c3163f35807
Established class (EPC) Pyrethroid
Chemical class Pyrethrins
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-01-22
Route TOPICAL
Dosage form CREAM
Substance PERMETHRIN
TE code (Orange Book) AB · RLD · RS

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

GCN Seq No 013631
GCN 44370
HICL code 021814
Ingredient (HICL) Permethrin
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 Q5R
Therapeutic class — specific (HIC3) Topical Antiparasitics
AHFS code 84:04.12.00
AHFS class Scabicides And Pediculicides
FDB label name ELIMITE 5% CREAM
FDB brand name Elimite
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 013631
  • GCN: 44370
  • HICL (First Databank): 021814
  • AHFS class code: 84:04.12.00
  • RxCUI (RxNorm): 106387
Why two NDCs? The FDA registers this code as 59651-834-60 — 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 → 59651-0834-60. 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 Pyrethroid class.

Pharmacologic class Pyrethroid
Drug family (ATC) Pyrethrines, incl. synthetic compounds
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 ELIMITE 5% CREAM Ingredient Permethrin
📗 Our plain-language guide HelloPharmacist
  • Elimite 5% Cream treats scabies, which is caused by a tiny mite. The lice creme rinse products are used when lice or nits are found in the hair. Make sure you use the right product...
  • Wash your hair with a shampoo that has no conditioner, then rinse and towel dry until damp. Saturate the hair and scalp, keep it out of your eyes, and leave it on for 10 minutes on...
  • If you see live lice seven days or more after the first treatment, you should do a second treatment. Check the head daily and keep combing out any nits you missed.
  • Burning, stinging, itching and redness where it was applied are the most common. These are usually mild and short-lived. Call your doctor if irritation keeps going, an infection de...
📖 Read our full Permethrin 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 $1.06 $63.40 / 60 g
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Where does this data come from?
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 Marketing startMarketing endStatus
59651-0834-60 You're viewing this Main listing 1 TUBE in 1 CARTON / 60 g in 1 TUBE 2024-01-22 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Permethrin 50 mg/g 00472-0242-60 Actavis 1 tube $0.224 AB Discontinued —
Permethrin 50 mg/g 16714-0897-01 Northstar 1 tube $0.229 AB Availability likely —
Permethrin 50 mg/g 21922-0021-07 Encube 1 tube $0.229 AB Availability likely —
Permethrin 50 mg/g 45802-0269-37 Padagis 1 tube $0.229 AB Availability likely —
Permethrin 50 mg/g 84386-0073-60 Aurobindo 1 tube $0.229 AB Availability likely —
Permethrin 50 mg/g 50090-5888-00 A-S 1 tube — AB FDA listed —
Elimite 50 mg/gthis 59651-0834-60 Aurobindo 1 tube — AB FDA listed —
Permethrin 50 mg/g 68788-8439-06 Preferred 1 tube — AB FDA listed —
Permethrin 50 mg/g 70518-2945-00 REMEDYREPACK 1 tube — AB FDA listed —
Permethrin 50 mg/g 71335-2899-01 Bryant 1 tube — AB FDA listed —
Permethrin 50 mg/g 72162-2171-06 Bryant 1 tube — AB FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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

🏛️
2024
On the market since
Jan 2024
📍
2026
Currently FDA-listed
2 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

Where does this data come from?
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 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • UNII HHT01ZNK31
    Carbomer Homopolymer Type B is a synthetic polymer made from acrylic acid. It absorbs water and forms a gel, so it's used in medicines as a thickener, suspending agent, and to help create a smooth texture in creams, gels, and lotions.
  • UNII 7H8VAM7778
    A synthetic compound derived from cetyl alcohol and ethylene oxide. It acts as an emulsifier and surfactant in medicines, helping blend water and oil-based ingredients together into a stable, uniform product.
  • UNII I835H2IHHX
    A waxy substance derived from plant oils, used as an emulsifier and solubilizer to help mix oil and water ingredients together and keep them blended throughout the product's shelf life.
  • UNII 1HG84L3525
    Formaldehyde is a preservative chemical that prevents bacterial and fungal growth in medicines. It keeps the product safe and stable during storage by stopping contamination.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII KC98RO82HJ
    A waxy substance made from glycerin and fatty acids. It acts as an emulsifier to help mix oil and water components, and as a thickener to give the medicine proper texture and consistency.
  • UNII 0RE8K4LNJS
    Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
  • UNII 884C3FA9HE
    Lanolin alcohol is a waxy substance derived from sheep's wool. It functions as an emollient and emulsifier in medicines, helping blend oil and water-based ingredients while softening the product's texture.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • 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 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.

13 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

LabelerAurobindo Pharma Limited
Application holderAUROBINDO PHARMA USA INC
FDA applicationNDA019855 (NDA)
Labeler code59651
First marketedJan 2024
Product typeHuman Prescription Drug
Portfolio1,456 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 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 19 words ▾

INDICATIONS AND USAGE ELIMITE ® (permethrin) 5% Cream is indicated for the treatment of infestation with Sarcoptes scabiei (scabies).

⏱️ Dosage and Administration 120 words ▾

DOSAGE AND ADMINISTRATION Adults and Children - Thoroughly massage ELIMITE ® (permethrin) 5% Cream into the skin from the head to the soles of the feet. Scabies rarely infests the scalp of adults, although the hairline, neck, temple, and forehead may be infested in infants and geriatric patients. Usually 30 grams is sufficient for an average adult.

The cream should be removed by washing (shower or bath) after 8 to 14 hours. Infants should be treated on the scalp, temple, and forehead. ONE APPLICATION IS GENERALLY CURATIVE.

Patients may experience persistent pruritus after treatment. This is rarely a sign of treatment failure and is not an indication for retreatment. Demonstrable living mites after 14 days indicate that retreatment is necessary.

⛔ Contraindications 24 words ▾

CONTRAINDICATIONS ELIMITE ® (permethrin) 5% Cream is contraindicated in patients with known hypersensitivity to any of its components, to any synthetic pyrethroid or pyrethrin.

⚠️ Warnings 12 words ▾

WARNINGS If hypersensitivity to ELIMITE ® (permethrin) 5% Cream occurs, discontinue use.

🤒 Adverse Reactions 117 words ▾

ADVERSE REACTIONS In clinical trials, generally mild and transient burning and stinging followed application with ELIMITE ® (permethrin) 5% Cream in 10% of patients and was associated with the severity of infestation. Pruritus was reported in 7% of patients at various times post-application. Erythema, numbness, tingling, and rash were reported in 1 to 2% or less of patients (see PRECAUTIONS: General ).

Other adverse events reported since marketing ELIMITE ® (permethrin) 5% Cream include: headache, fever, dizziness, abdominal pain, diarrhea and nausea and/or vomiting. Although extremely uncommon and not expected when used as directed (see DOSAGE AND ADMINISTRATION ), rare occurrences of seizure have been reported. None have been medically confirmed as associated with ELIMITE ® treatment.

🤰 Pregnancy 66 words ▾

Pregnancy - Reproduction studies have been performed in mice, rats, and rabbits (200 to 400 mg/kg/day orally) and have revealed no evidence of impaired fertility or harm to the fetus due to permethrin. 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 36 words ▾

Pediatric Use - ELIMITE ® (permethrin) 5% Cream is safe and effective in pediatric patients two months of age and older. Safety and effectiveness in infants less than two months of age have not been established.

🧓 Geriatric Use 102 words ▾

Geriatric Use - Clinical studies of ELIMITE ® (permethrin) 5% Cream did not identify sufficient numbers of subjects aged 65 and over to allow a definitive statement regarding whether elderly subjects respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. This drug is known to be substantially excreted by the kidney.

However, since topical permethrin is metabolized in the liver and excreted in the urine as inactive metabolites, there does not appear to be an increased risk of toxic reactions in patients with impaired renal function when used as labeled.

🆘 Overdosage 41 words ▾

OVERDOSAGE No instance of accidental ingestion of ELIMITE ® (permethrin) 5% Cream has been reported. If ingested, gastric lavage and general supportive measures should be employed. Excessive topical use (see DOSAGE AND ADMINISTRATION ) may result in increased irritation and erythema.

🧬 Clinical Pharmacology 123 words ▾

CLINICAL PHARMACOLOGY Permethrin, a pyrethroid, is active against a broad range of pests including lice, ticks, fleas, mites, and other arthropods. It acts on the nerve cell membrane to disrupt the sodium channel current by which the polarization of the membrane is regulated. Delayed repolarization and paralysis of the pests are the consequences of this disturbance.

Permethrin is rapidly metabolized by ester hydrolysis to inactive metabolites which are excreted primarily in the urine. Although the amount of permethrin absorbed after a single application of the 5% cream has not been determined precisely, data from studies with 14 C-labeled permethrin and absorption studies of the cream applied to patients with moderate to severe scabies indicate it is 2% or less of the amount applied.

📦 How Supplied / Storage and Handling 66 words ▾

HOW SUPPLIED ELIMITE ® Cream, 5% contains 50 mg permethrin per gram. The off-white, greaseless, uniform mass is available as follows: Carton containing one 60 g tube NDC 59651-834-60 STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature.] Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 11/2023

📋 Description 147 words ▾

DESCRIPTION ELIMITE ® (permethrin) 5% Cream is a topical scabicidal agent for the treatment of infestation with Sarcoptes scabiei (scabies). It is available in an off-white, greaseless, uniform mass. ELIMITE ® (permethrin) 5% Cream is for topical use only.

Chemical Name - The permethrin used is an approximate 1:3 mixture of the cis and trans isomers of the pyrethroid 3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropanecarboxylic acid, (3-phenoxyphenyl) methyl ester. Permethrin has a molecular formula of C 21 H 20 CI 2 O 3 and a molecular weight of 391.29. It is a colorless or slightly brownish viscous liquid, semi-solid or crystalline solid.

Active Ingredient - Each gram contains permethrin 50 mg (5%). Inactive Ingredients - Butylated hydroxytoluene, carbomer homopolymer type B, ceteth-2, ceteth-20, glycerin, isopropyl myristate, lanolin alcohols, medium chain triglycerides, mineral oil, mono and di-glycerides, purified water, and sodium hydroxide. Formaldehyde 1 mg (0.1%) is added as a preservative.

Chemical Structure

💬 Information for Patients 101 words ▾

Information for Patients - Patients with scabies should be advised that itching, mild burning and/or stinging may occur after application of ELIMITE ® (permethrin) 5% Cream. In clinical trials, approximately 75% of patients treated with ELIMITE ® (permethrin) 5% Cream who continued to manifest pruritus at 2 weeks had cessation by 4 weeks. If irritation persists, they should consult their physician.

ELIMITE ® (permethrin) 5% Cream may be very mildly irritating to the eyes. Patients should be advised to avoid contact with eyes during application and to flush with water immediately if ELIMITE ® (permethrin) 5% Cream gets in the eyes.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General - Scabies infestation is often accompanied by pruritus, edema, and erythema. Treatment with ELIMITE ® (permethrin) 5% Cream may temporarily exacerbate these conditions. Information for Patients - Patients with scabies should be advised that itching, mild burning and/or stinging may occur after application of ELIMITE ® (permethrin) 5% Cream.

In clinical trials, approximately 75% of patients treated with ELIMITE ® (permethrin) 5% Cream who continued to manifest pruritus at 2 weeks had cessation by 4 weeks. If irritation persists, they should consult their physician. ELIMITE ® (permethrin) 5% Cream may be very mildly irritating to the eyes.

Patients should be advised to avoid contact with eyes during application and to flush with water immediately if ELIMITE ® (permethrin) 5% Cream gets in the eyes. Carcinogenesis, Mutagenesis, Impairment of Fertility - Six carcinogenicity bioassays were evaluated with permethrin, three each in rats and mice. No tumorigenicity was seen in the rat studies.

However, species-specific increases in pulmonary adenomas, a common benign tumor of mice of high spontaneous background incidence, were seen in the three mouse studies. In one of these studies there was an increased incidence of pulmonary alveolar-cell carcinomas and benign liver adenomas only in female mice when permethrin was given in their food at a concentration of 5000 ppm. Mutagenicity assays, which give useful correlative data for interpreting results from carcinogenicity bioassays in rodents, were negative.

Permethrin showed no evidence of mutagenic potential in a battery of in vitro and in vivo genetic toxicity studies. Permethrin did not have any adverse effect on reproductive function at a dose of 180 mg/kg/day orally in a three-generation rat study. Pregnancy - Reproduction studies have been performed in mice, rats, and rabbits (200 to 400 mg/kg/day orally) and have revealed no evidence of impaired fertility or harm to the fetus due to permethrin.

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 and because of the evidence for tumorigenic potential of permethrin in animal studies, consideration should be given to discontinuing nursing temporarily or withholding the drug while the mother is nursing. Pediatric Use - ELIMITE ® (permethrin) 5% Cream is safe and effective in pediatric patients two months of age and older. Safety and effectiveness in infants less than two months of age have not been established.

Geriatric Use - Clinical studies of ELIMITE ® (permethrin) 5% Cream did not identify sufficient numbers of subjects aged 65 and over to allow a definitive statement regarding whether elderly subjects respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. This drug is known to be substantially excreted by the kidney.

However, since topical permethrin is metabolized in the liver and excreted in the urine as inactive metabolites, there does not appear to be an increased risk of toxic reactions in patients with impaired renal function when used as labeled.

🍼 Nursing Mothers 53 words ▾

Nursing Mothers - It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the evidence for tumorigenic potential of permethrin in animal studies, consideration should be given to discontinuing nursing temporarily or withholding the drug while the mother is nursing.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 144 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility - Six carcinogenicity bioassays were evaluated with permethrin, three each in rats and mice. No tumorigenicity was seen in the rat studies. However, species-specific increases in pulmonary adenomas, a common benign tumor of mice of high spontaneous background incidence, were seen in the three mouse studies.

In one of these studies there was an increased incidence of pulmonary alveolar-cell carcinomas and benign liver adenomas only in female mice when permethrin was given in their food at a concentration of 5000 ppm. Mutagenicity assays, which give useful correlative data for interpreting results from carcinogenicity bioassays in rodents, were negative. Permethrin showed no evidence of mutagenic potential in a battery of in vitro and in vivo genetic toxicity studies.

Permethrin did not have any adverse effect on reproductive function at a dose of 180 mg/kg/day orally in a three-generation rat study.

📄 Package Label / Principal Display Panel 92 words ▾

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5% Container Label (60 g Tube) NDC 59651-834-60 Rx only ELIMITE ® CREAM (PERMETHRIN) 5% * *W/W FOR EXTERNAL USE ONLY. NOT FOR USE IN EYES. AUROBINDO 60 g PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5% Container Label (60 g Tube)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5% Container Carton Label (60 g Tube) NDC 59651-834-60 Rx only ELIMITE ® CREAM (PERMETHRIN) 5% * *W/W FOR EXTERNAL USE ONLY. NOT FOR USE IN EYES. AUROBINDO 60 g PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5% Container Carton Label (60 g Tube)

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
91
Units reimbursed last 4 qtrs
6K
Gross reimbursed last 4 qtrs
$6.3K
Avg / prescription
$69.67
Avg / unit
$1.0566
Latest quarter Q1 2026
0Rx
Fee-for-service vs managed care ⓘ
46% FFS 54% MCO
Fee-for-service · 42 Rx Managed care · 49 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: no data reported MI New York: no data reported 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: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 2,760 units · 7.1 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported 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: 3,240 units · 10.6 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
7.110.6
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 Texas 10.6 /100k
2 California 7.1 /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 Elimite — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Elimite. 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
$2.4K
Claims incl. refills
26
Beneficiaries
26
Spend / beneficiary
$91.58
Spend / claim
$91.58
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.

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 — Not published for this NDC No photo available yet for this listing.
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) ✓ Available
“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 Aurobindo Pharma Limited. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Aurobindo Pharma Limited 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.
← 59651-0826-55 · Aurobindo 59651-0835-30 · Aurobindo →
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.