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Erythromycin 20 mg/g Gel — NDC 45802-0966-96 package photo

Erythromycin 20 mg/g Gel

by Padagis Israel Pharmaceuticals Ltd · 1 TUBE in 1 CARTON (45802-966-96) / 60 g in 1 TUBE
NDC 45802-0966-96
🏷️ FDA NDC (as labeled) 45802-966-96 billing pads the product segment with a zero
This package
Contains60 g in 1 tube Cost per g$0.6827 NADAC Per package$40.96 / 60 g Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.8370/unit · Part D plans $0.9953/unit — full pricing hub ↓
Also comes in: 30 g 45802-0966-94
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 →
⚠️
Other active recalls for Erythromycin (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Apr 29, 2026 — CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit (Zydus Pharmaceuticals (USA) Inc) · FDA recall D-0545-2026
Class II · Apr 29, 2026 — CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit (Zydus Pharmaceuticals (USA) Inc) · FDA recall D-0544-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 45802-966-96
Product NDC 45802-966
11-digit billing NDC 45802096696
NCPDP billing unit GM — per gram (weight)
RxCUI 310152
UNII 63937KV33D
Application # ANDA063211
SPL Set ID dd64459e-c88f-4ca8-b63b-fb96377a3921
Established class (EPC) Macrolide; Macrolide Antimicrobial
Physiologic effect Decreased Sebaceous Gland Activity
Chemical class Macrolides
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2008-06-12
Route TOPICAL
Dosage form GEL
Substance ERYTHROMYCIN
GPI-14 90051020004010
GPI class Erythromycin
GCN Seq No 007680
GCN 31710
HICL code 008712
Ingredient (HICL) Erythromycin Base In Ethanol
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 08:12.12.04
AHFS class Erythromycin Antibiotics
FDB label name ERYTHROMYCIN 2% GEL
FDB brand name Erythromycin
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 45802-966-96 — 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 → 45802-0966-96. 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 Macrolide class.

Pharmacologic class Macrolide, Macrolide Antimicrobial
Drug family (ATC) Antiinfectives for treatment of acne, Macrolides, 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

LabelerPadagis Israel Pharmaceuticals Ltd
Application holderPADAGIS US LLC
FDA applicationANDA063211 (ANDA)
Labeler code45802
First marketedJun 2008
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.

🩺 Clinical

Label name ERYTHROMYCIN 2% GEL Ingredient Erythromycin Base In Ethanol
📗 Our plain-language guide HelloPharmacist
  • Erythromycin treats a pretty wide range of bacterial infections. That includes respiratory infections like bronchitis and pneumonia, skin infections, whooping cough, Legionnaires'...
  • What kinds of infections does erythromycin treat?
  • It depends on the form you have. If you're taking ERY-TAB delayed-release tablets, they work best on an empty stomach — ideally about 2 hours before a meal, though taking them with...
  • Can I take this on an empty stomach, or do I need food?
📖 Read our full Erythromycin guide →
7
Nutrient depletion considerations

Erythromycin may be associated with lower levels of 7 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 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII 9XZ8H6N6OH
    A plant-based cellulose derivative used as a binder to hold tablet ingredients together, a thickener in liquids, and a coating agent to control how fast the medicine dissolves.

2 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.

💲 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 $0.683 $40.96 / 60 g
Medicaid paysCMS SDUD · 12 mo $0.8370 $50.22 / 60 g
Medicare drug plans payPart D · Q2 2026 $0.9953 $59.72 / 60 g
NADAC price history (per g) — tap or hover for the price & month
Dec 2021 Aug 2022 Jan 2026 Sep 2026 $0.977 $0.523
▲ Up 30% over the last 23 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
Erythromycin 20 mg/gthis 45802-0966-96 Padagis 1 tube $0.683 AT Availability likely —
Erythromycin 20 mg/g 63629-8652-01 Bryant 1 tube — AT FDA listed —
Erythromycin 20 mg/g 63629-8653-01 Bryant 1 tube — AT FDA listed —
Erythromycin 20 mg/g 72162-1444-03 Bryant 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

🏛️
2008
On the market since
Jun 2008
📍
2026
Currently FDA-listed
18 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 45802-0966-96, 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
7.9K
Units reimbursed last 4 qtrs
481.5K
Gross reimbursed last 4 qtrs
$403K
Avg / prescription
$51.03
Avg / unit
$0.8370
Latest quarter Q1 2026
1.8KRx
Medicaid pays / g
$0.8370
gross reimbursed
vs
NADAC / g
$0.6827
acquisition cost
=
Spread
+$0.1543
+23% 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 ⓘ
68% FFS 32% MCO
Fee-for-service · 5,389 Rx Managed care · 2,509 Rx
State Medicaid map
Alaska: no data reported AK Maine: 7,200 units · 516 per 100k residents ME Washington: no data reported WA Idaho: 2,370 units · 121 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 8,520 units · 149 per 100k residents MN Wisconsin: 4,680 units · 79.2 per 100k residents WI Michigan: 900 units · 9.0 per 100k residents MI New York: 277,742 units · 1,419 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 3,720 units · 87.9 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 1,380 units · 43.0 per 100k residents IA Illinois: 18,150 units · 145 per 100k residents IL Indiana: 3,930 units · 57.3 per 100k residents IN Ohio: 22,141 units · 188 per 100k residents OH Pennsylvania: 3,960 units · 30.6 per 100k residents PA New Jersey: 11,790 units · 127 per 100k residents NJ Massachusetts: 19,410 units · 277 per 100k residents MA California: 12,240 units · 31.4 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 2,460 units · 124 per 100k residents NE Missouri: 4,680 units · 75.5 per 100k residents MO Kentucky: 1,320 units · 29.2 per 100k residents KY West Virginia: 9,060 units · 512 per 100k residents WV Virginia: 2,100 units · 24.1 per 100k residents VA Maryland: 7,320 units · 118 per 100k residents MD Connecticut: 4,320 units · 119 per 100k residents CT Rhode Island: no data reported RI Arizona: 9,600 units · 129 per 100k residents AZ New Mexico: 4,020 units · 190 per 100k residents NM Kansas: 780 units · 26.5 per 100k residents KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 10,710 units · 98.8 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 3,180 units · 69.5 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 11,040 units · 100 per 100k residents GA D.C.: no data reported DC Hawaii: 720 units · 50.2 per 100k residents HI Texas: 12,060 units · 39.5 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
9.01,419
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 1,419 /100k
2 Maine 516 /100k
3 West Virginia 512 /100k
4 Massachusetts 277 /100k
5 New Mexico 190 /100k
6 Ohio 188 /100k
7 Minnesota 149 /100k
8 Illinois 145 /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 tube45802-0966-94 9,659 Rx · $326,633
1 tube this page45802-0966-96 7,898 Rx · $403,024
Drug total (last 4 qtrs): 17,557 Rx · 821,904 units · $729,657 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 Erythromycin — the program that covers self-administered drugs. 12 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 Erythromycin. 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
$6.84M
Claims incl. refills
399.1K
Beneficiaries
329.3K
Spend / beneficiary
$20.78
Spend / claim
$17.15
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.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
45802-0966-94 1 TUBE in 1 CARTON (45802-966-94) / 30 g in 1 TUBE $0.6726 / g $20.18 2008-09-08 Active
45802-0966-96 You're viewing this 1 TUBE in 1 CARTON (45802-966-96) / 60 g in 1 TUBE $0.6827 / g $40.96 2008-06-12 Active

This pack accounts for about 45% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in NDC 45802-0966-96?
NDC 45802-0966-96 is listed by the FDA — 1 tube in 1 carton / 60 g in 1 tube.
What NDC number is used to bill for this package of Erythromycin 20 mg/g Gel?
Bill NDC 45802-0966-96 — the 11-digit billing format is 45802096696. 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.

📄 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 17 words ▾

INDICATIONS AND USAGE Erythromycin Topical Gel USP, 2% is indicated for the topical treatment of acne vulgaris.

⏱️ Dosage and Administration 84 words ▾

DOSAGE AND ADMINISTRATION Erythromycin Topical Gel USP, 2% should be applied sparingly as a thin film to affected area(s) once or twice a day after the skin is thoroughly cleansed and patted dry. If there has been no improvement after 6 to 8 weeks, or if the condition becomes worse, treatment should be discontinued, and the physician should be reconsulted. Spread the medication lightly rather than rubbing it in.

There are no data directly comparing the safety and efficacy of b.i.d. versus q.d. dosing.

⛔ Contraindications 20 words ▾

CONTRAINDICATIONS Erythromycin Topical Gel USP, 2% is contraindicated in those individuals who have shown hypersensitivity to any of its components.

⚠️ Warnings 130 words ▾

WARNINGS Pseudomembranous colitis has been reported with nearly all antibacterial agents, including erythromycin, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia.

Studies indicate that a toxin produced by Clostridium difficile is one primary cause of “antibiotic-associated colitis”. After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone.

In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against C. difficile colitis.

🤒 Adverse Reactions 74 words ▾

ADVERSE REACTIONS In controlled clinical trials, the incidence of burning associated with erythromycin topical gel USP, 2% was approximately 25%. The following additional local adverse reactions have been reported occasionally: peeling, dryness, itching, erythema, and oiliness. Irritation of the eyes and tenderness of the skin have also been reported with the topical use of erythromycin.

A generalized urticarial reaction, possibly related to the use of erythromycin, which required systemic steroid therapy has been reported.

🤰 Pregnancy 96 words ▾

Pregnancy: Teratogenic Effects: Pregnancy Category B - There was no evidence of teratogenicity or any other adverse effect on reproduction in female rats fed erythromycin base (up to 0.25% of diet) prior to and during mating, during gestation and through weaning of two successive litters. 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 in pregnancy only if clearly needed.

Erythromycin has been reported to cross the placental barrier in humans, but fetal plasma levels are generally low.

🧒 Pediatric Use 19 words ▾

Pediatric Use - Safety and effectiveness in pediatric patients have not been established. KEEP OUT OF REACH OF CHILDREN.

🧬 Clinical Pharmacology 73 words ▾

CLINICAL PHARMACOLOGY The exact mechanism by which erythromycin reduces lesions of acne vulgaris is not fully known; however, the effect appears to be due in part to the antibacterial activity of the drug. MICROBIOLOGY Erythromycin acts by inhibition of protein synthesis in susceptible organisms by reversibly binding to 50S ribosomal subunits, thereby inhibiting translocation of aminoacyl transfer-RNA and inhibiting polypeptide synthesis. Antagonism has been demonstrated in vitro between erythromycin, lincomycin, chloramphenicol, and clindamycin.

📦 How Supplied / Storage and Handling 29 words ▾

HOW SUPPLIED Erythromycin Topical Gel USP, 2% is available as follows: 30 g sealed metal tube (NDC 45802- 966 -94) 60 g sealed metal tube (NDC 45802- 966 -96)

📦 Storage and Handling 29 words ▾

STORAGE Note - FLAMMABLE. Keep away from heat and flame. Store and dispense in original container. Keep tube tightly closed. Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

📋 Description 177 words ▾

DESCRIPTION Erythromycin Topical Gel USP, 2% contains erythromycin (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-Dideoxy-3- C -methyl-3- O -methyl-α-L- ribo -hexopyranosyl)oxy]-14-ethyl-7, 12, 13-trihydroxy-3, 5, 7, 9, 11, 13-hexamethyl-6-[[3, 4, 6,-trideoxy-3-(dimethylamino)-β-D- xylo -hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione), for topical dermatological use. Erythromycin is a macrolide antibiotic produced from a strain of Saccaropolyspora erythraea (formerly Streptomyces erythreus ). It is a base and readily forms salts with acids.

Chemically, erythromycin is C 37 H 67 NO 13 . It has the following structural formula: Erythromycin has a molecular weight of 733.94. It is a white or slightly yellow, odorless or practically odorless, bitter crystalline powder.

Erythromycin is very soluble in very polar organic solvents such as alcohols, acetone, chloroform, acetonitrile and ethyl acetate. It is moderately soluble in less polar solvents such as ether, dichloroethylene and amyl acetate. It is slightly soluble in nonpolar solvents such as hexane.

It is very poorly soluble in water. Each gram of Erythromycin Topical Gel USP, 2% contains 20 mg of erythromycin USP in a vehicle consisting of dehydrated alcohol and hydroxypropyl cellulose. structure

💬 Information for Patients 94 words ▾

Information For Patients - Patients using Erythromycin Topical Gel USP, 2% should receive the following information and instructions: 1. This medication is to be used as directed by the physician. It is for external use only.

Avoid contact with the eyes, nose, mouth, and all mucous membranes. 2. This medication should not be used for any disorder other than that for which it was prescribed.

3. Patients should not use any other topical acne medication unless otherwise directed by their physician. 4.

Patients should report to their physician any signs of local adverse reactions.

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.