erythromycin topical solution 2% 20 mg/mL Solution — NDC 71656-0030-60 package photo

erythromycin topical solution 2% 20 mg/mL Solution

by Saptalis Pharmaceuticals, LLC LLC · 1 BOTTLE in 1 CARTON (71656-030-60) / 60 mL in 1 BOTTLE
NDC 71656-0030-60
🏷️ FDA NDC (as labeled) 71656-030-60 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) 71656-030-60
Product NDC 71656-030
11-digit billing NDC 71656003060
NCPDP billing unit ML — per mL (volume)
RxCUI 318202
UNII 63937KV33D
UPC 0371656030605
Application # ANDA062687
SPL Set ID 21b64a3f-2c95-1c1a-e063-6294a90a0ea0
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 2024-08-14
Route TOPICAL
Dosage form SOLUTION
Substance ERYTHROMYCIN
GPI-14 90051020002010
GCN Seq No 029325
GCN 77562
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% SOLUTION
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 71656-030-60 — 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 → 71656-0030-60. 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 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

LabelerSaptalis Pharmaceuticals, LLC LLC
Application holderMICRO LABS LTD
FDA applicationANDA062687 (ANDA)
Labeler code71656
First marketedAug 2024
Product typeHuman Prescription Drug
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% SOLUTION 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 →
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 XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.

3 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 mLPer package
Retail pharmacies payNADAC · weekly $0.352 $21.12 / 60 ml
Medicaid paysCMS SDUD · 12 mo $0.4417 $26.50 / 60 ml
Medicare drug plans payPart D · Q2 2026 $0.4210 $25.26 / 60 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $0.390 $0.336
▼ Down 10% over the last 10 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/mL 45802-0038-46 Padagis 1 bottle $0.352 AT Availability likely —
erythromycin topical solution 2% 20 mg/mLthis 71656-0030-60 Saptalis 1 bottle $0.352 AT Availability likely —
erythromycin 20 mg/mL 68071-4791-06 NuCare 60 ml — AT FDA listed —
erythromycin 20 mg/mL 72162-2075-06 Bryant 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

🏛️
2024
On the market since
Aug 2024
📍
2026
Currently FDA-listed
2 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 71656-0030-60, 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
5.5K
Units reimbursed last 4 qtrs
340.4K
Gross reimbursed last 4 qtrs
$150.3K
Avg / prescription
$27.18
Avg / unit
$0.4417
Latest quarter Q1 2026
1.3KRx
Medicaid pays / mL
$0.4417
gross reimbursed
vs
NADAC / mL
$0.3520
acquisition cost
=
Spread
+$0.0897
+25% 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 ⓘ
35% FFS 65% MCO
Fee-for-service · 1,959 Rx Managed care · 3,571 Rx
State Medicaid map
Alaska: no data reported AK Maine: 780 units · 55.9 per 100k residents ME Washington: 10,440 units · 134 per 100k residents 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: 13,620 units · 136 per 100k residents MI New York: 79,860 units · 408 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: 14,880 units · 119 per 100k residents IL Indiana: 9,720 units · 142 per 100k residents IN Ohio: 13,440 units · 114 per 100k residents OH Pennsylvania: 15,180 units · 117 per 100k residents PA New Jersey: 68,100 units · 733 per 100k residents NJ Massachusetts: 12,480 units · 178 per 100k residents MA California: 27,900 units · 71.6 per 100k residents CA Utah: no data reported UT Colorado: 2,220 units · 37.8 per 100k residents CO Nebraska: 660 units · 33.4 per 100k residents NE Missouri: no data reported MO Kentucky: 2,640 units · 58.3 per 100k residents KY West Virginia: 3,180 units · 180 per 100k residents WV Virginia: 8,100 units · 92.9 per 100k residents VA Maryland: 19,020 units · 308 per 100k residents MD Connecticut: 5,940 units · 164 per 100k residents CT Rhode Island: no data reported RI Arizona: 9,300 units · 125 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 5,580 units · 51.5 per 100k residents NC South Carolina: 3,060 units · 57.0 per 100k residents 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: 12,840 units · 116 per 100k residents GA D.C.: 1,410 units · 208 per 100k residents DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
33.4733
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 Jersey 733 /100k
2 New York 408 /100k
3 Maryland 308 /100k
4 D.C. 208 /100k
5 West Virginia 180 /100k
6 Massachusetts 178 /100k
7 Connecticut 164 /100k
8 Indiana 142 /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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
71656-0030-60 You're viewing this 1 BOTTLE in 1 CARTON (71656-030-60) / 60 mL in 1 BOTTLE 2024-08-14 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 16 words ▾

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

⏱️ Dosage and Administration 78 words ▾

DOSAGE AND ADMINISTRATION Erythromycin topical solution, 2% should be applied over the affected areas twice a day (morning and evening) after the skin is thoroughly washed with warm water and soap and patted dry. Acne lesions on the face, neck, shoulders, chest, and back may be treated in this manner. This medication should be applied with applicator top.

If fingertips are used, wash hands after application. Drying and peeling may be controlled by reducing the frequency of applications.

⛔ Contraindications 19 words ▾

CONTRAINDICATIONS Erythromycin topical solution, 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 70 words ▾

ADVERSE REACTIONS The following 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 topical use of erythromycin. Generalized urticarial reactions possibly related to the use of erythromycin, which required systemic steroid therapy have been reported.

To report SUSPECTED ADVERSE REACTIONS, contact Saptalis Pharmaceuticals, LLC at 1-833-727-8254 or FDA at 1-­800‑FDA‑1088 or www.fda.gov/medwatch.

🤰 Pregnancy 90 words ▾

Pregnancy 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 15 words ▾

Pediatric Use Safety and effectiveness of this product in pediatric patients have not been established.

🧬 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 35 words ▾

HOW SUPPLIED Erythromycin topical solution, USP 2% is available as follows: 60 mL bottle with applicator (NDC 71656-030-60) Store at 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed.

📋 Description 136 words ▾

DESCRIPTION Erythromycin topical solution, USP 2% contains erythromycin, USP for topical dermatologic 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: (3 R *,4 S *,5 S *,6 R *,7 R *,9 R *,11 R *,12 R *,13 S *,14 R *)-4-[(2,6-Dideoxy-3- C -methyl-3- 0 -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)-ß-D- xylo -hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione. It has the following structural formula: Molecular Formula: C 37 H 67 NO 13 Molecular Weight: 733.94 Erythromycin, USP is a white or slightly yellow, crystalline powder that is soluble in water, alcohol, chloroform and in ether.

Each mL of erythromycin topical solution, USP 2% contains 20 mg of erythromycin base in a vehicle consisting of alcohol (66%), citric acid, and propylene glycol. formula

💬 Information for Patients 88 words ▾

Information for Patients Patients using erythromycin topical solution, 2% should receive the following information and instructions: 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.

This medication should not be used for any disorder other than that for which it was prescribed. Patients should not use any other topical acne medication unless otherwise directed by their physician. 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.