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ERYTHROMYCIN 5 mg/g Ointment, 3.5 g — NDC 61919-0090-35 package photo

ERYTHROMYCIN 5 mg/g Ointment, 3.5 g

by Direct Rx · 3.5 g in 1 CARTON (61919-090-35)
NDC 61919-0090-35
🏷️ FDA NDC (as labeled) 61919-090-35 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
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) 61919-090-35
Product NDC 61919-090
11-digit billing NDC 61919009035
NCPDP billing unit GM — per gram (weight)
RxCUI 310149
UNII 63937KV33D
Application # ANDA064067
SPL Set ID 9ac4dcd2-8cac-404d-b651-da74062d30ed
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 2014-01-01
Route OPHTHALMIC
Dosage form OINTMENT
Substance ERYTHROMYCIN
GPI-14 86101025004210
GPI class Erythromycin
GCN Seq No 007948
GCN 33540
HICL code 004022
Ingredient (HICL) Erythromycin Base
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 08:12.12.04
AHFS class Erythromycin Antibiotics
FDB label name ERYTHROMYCIN 0.5% EYE OINTMENT
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 61919-090-35 — 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 → 61919-0090-35. 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

LabelerDirect Rx
Application holderBAUSCH AND LOMB INC
FDA applicationANDA064067 (ANDA)
Labeler code61919
First marketedJan 2014
Product typeHuman Prescription Drug
Portfolio204 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 0.5% EYE OINTMENT Ingredient Erythromycin Base
📖 What it is MedlinePlus · NLM

Erythromycin ophthalmic is used to treat bacterial infections of the eye and prevent bacterial infections of the eye in newborn babies. Erythromycin is in a class of medications called macrolide antibiotics. It works by killing bacteria that cause infections.

Read the full MedlinePlus article ↗
📗 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.

🧪 Full Erythromycin nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 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 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 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.

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 Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $3.24 $11.34 / 3.5 g
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 5 mg/g 24208-0910-19 Bausch 50 tubes $6.716 AT Availability likely —
Erythromycin 5 mg/g 70244-0031-01 Sentiss 50 tubes $6.716 AT Availability likely —
Erythromycin 5 mg/g 72485-0670-31 ARMAS 50 tubes $6.716 AT Availability likely —
Erythromycin 5 mg/g 48102-0057-11 Fera 50 tubes — — FDA listed —
Erythromycin 5 mg/g 50090-1484-00 A-S 1 tube — AT FDA listed —
erythromycin 5 mg/g 50090-1958-00 A-S 1 tube — — FDA listed —
Erythromycin 5 mg/g 55154-7850-00 Cardinal 10 tubes — AT FDA listed —
Erythromycin 5 mg/g 60760-0670-35 ST. 1 tube — AT FDA listed —
Erythromycin 5 mg/gthis 61919-0090-35 Direct 3.5 g — AT FDA listed —
Erythromycin 5 mg/g 63187-0267-35 Proficient 1 tube — AT FDA listed —
Erythromycin 5 mg/g 63187-0608-35 Proficient 1 tube — AT FDA listed —
Erythromycin 5 mg/g 66267-0975-35 NuCare 3.5 g — AT FDA listed —
Erythromycin 5 mg/g 67296-2128-03 Redpharm 1 tube — AT FDA listed —
Erythromycin 5 mg/g 68071-3992-02 NuCare 1 tube — AT FDA listed —
Erythromycin 5 mg/g 68071-4228-03 NuCare 3.5 g — AT FDA listed —
erythromycin 5 mg/g 68071-4803-03 NuCare 3.5 g — — FDA listed —
Erythromycin 5 mg/g 68788-9328-03 Preferred 1 tube — AT FDA listed —
Erythromycin 5 mg/g 70518-0465-00 REMEDYREPACK 1 tube — AT FDA listed —
Erythromycin 5 mg/g 76420-0196-03 Asclemed 1 tube — AT FDA listed —
Erythromycin 5 mg/g 76420-0212-30 Asclemed 1 tube — AT FDA listed —
erythromycin 5 mg/g 76420-0612-03 Asclemed 1 tube — — FDA listed —
Erythromycin 5 mg/g 85766-0248-55 Sportpharm 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

🏛️
2014
On the market since
Jan 2014
📍
2026
Currently FDA-listed
12 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.

📊 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 Marketing startStatus
61919-0090-35 You're viewing this 3.5 g in 1 CARTON (61919-090-35) 2015-01-01 Active

🧭 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 ✓ Available
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) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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 FDA registers it as 61919-090-35, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 61919-0090-35, written without dashes as 61919009035. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 61919-0090-35, the first segment (61919) is the labeler code FDA assigned to Direct Rx; the middle segment (0090) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (35) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Direct Rx. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Direct Rx 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 97 words ▾

INDICATIONS AND USAGE For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to erythromycin. For prophylaxis of ophthalmia neonatorum due to N. gonorrhoeae or C. trachomatis. The effectiveness of erythromycin in the prevention of ophthalmia caused by penicillinase-producing N. gonorrhoeae is not established.

For infants born to mothers with clinically apparent gonorrhea, intravenous or intramuscular injections of aqueous crystalline penicillin G should be given; a single dose of 50,000 units for term infants or 20,000 units for infants of low birth weight. Topical prophylaxis alone is inadequate for these infants.

⏱️ Dosage and Administration 83 words ▾

DOSAGE AND ADMINISTRATION In the treatment of superficial ocular infections, erythromycin ophthalmic ointment approximately 1 cm in length should be applied directly to the infected eye(s) up to six times daily, depending on the severity of the infection. For prophylaxis of neonatal gonococcal or chlamydial ophthalmia, a ribbon of ointment approximately 1 cm in length should be instilled into each lower conjunctival sac. The ointment should not be flushed from the eye following instillation.

A new tube should be used for each infant.

⛔ Contraindications 14 words ▾

CONTRAINDICATIONS This drug is contraindicated in patients with a history of hypersensitivity to erythromycin.

🤒 Adverse Reactions 16 words ▾

ADVERSE REACTIONS The most frequently reported adverse reactions are minor ocular irritations, redness and hypersensitivity reactions.

🧬 Clinical Pharmacology 79 words ▾

CLINICAL PHARMACOLOGY Microbiology Erythromycin inhibits protein synthesis without affecting nucleic acid synthesis. Erythromycin is usually active against the following organisms in vitro and in clinical infections: Streptococcus pyogenes (group A β-hemolytic), Alpha-hemolytic streptococci (viridans group); Staphylococcus aureu s, including penicillinase-producing strains (methicillin-resistant staphylococci are uniformly resistant to erythromycin); Streptococcus pneumoniae; Mycoplasma pneumoniae (Eaton Agent, PPLO); Haemophilus influenzae (not all strains of this organism are susceptible at the erythromycin concentrations ordinarily achieved); Treponema pallidum; Corynebacterium diphtheriae; Neisseria gonorrhoeae; Chlamydia trachomatis.

📦 How Supplied / Storage and Handling 83 words ▾

HOW SUPPLIED Erythromycin Ophthalmic Ointment USP, 0.5% is available in the following sizes: 1/8 oz. (3.5 g) tamper-resistant tube - NDC 24208-910-55 DO NOT USE IF CAP AND NECKRING ARE NOT INTACT. 1 g tin container (in cartons of 50) - NDC 24208-910-19 DO NOT USE IF BOTTOM RIDGE OF TUBE CAP IS EXPOSED.

Storage: Store between 15°-25°C (59°-77°F). KEEP OUT OF REACH OF CHILDREN. Revised: January 2013 Bausch & Lomb Incorporated Tampa, FL 33637 ©Bausch & Lomb Incorporated 9043403 (Folded) 9043503 (Flat)

📋 Description 109 words ▾

DESCRIPTION Erythromycin Ophthalmic Ointment USP belongs to the macrolide group of antibiotics. The sterile ophthalmic ointment flows freely over the conjunctiva. Erythromycin base, as crystals or powder, is slightly soluble in water, moderately soluble in ether, and readily soluble in alcohol or chloroform.

Erythromycin is an antibiotic produced from a strain of Streptomyces erythraeus. It is basic and readily forms a salt when combined with an acid. It has the following structural formula: Chemical Name: (3R•, 4S•, 5S•, 6R•, 7R•, 9R•, 11R•, 12R•, 13S•, 14R•)-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)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2, 10-dione Each Gram Contains: ACTIVE: Erythromycin, USP 5 mg (0.5%); INACTIVES: Mineral Oil, White Petrolatum. image description

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 61919-0082-20 · DIRECT 61919-0106-05 · DIRECT →
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.