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FLUOCINOLONE ACETONIDE .11 mg/mL Oil — NDC 70752-0159-20 package photo

FLUOCINOLONE ACETONIDE .11 mg/mL Oil

by Quagen Pharmaceuticals LLC · 1 BOTTLE in 1 CARTON (70752-159-20) / 20 mL in 1 BOTTLE
NDC 70752-0159-20
🏷️ FDA NDC (as labeled) 70752-159-20 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 Fluocinolone Acetonide (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class III · Dec 30, 2025 — Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D. (SUN PHARMACEUTICAL INDUSTRIES INC) · FDA recall D-0256-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 70752-159-20
Product NDC 70752-159
11-digit billing NDC 70752015920
NCPDP billing unit ML — per mL (volume)
RxCUI 1191299
UNII 0CD5FD6S2M
Application # ANDA212762
SPL Set ID 2bcea813-d629-42c5-8953-fa231b4cbf58
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-04-02
Route AURICULAR (OTIC)
Dosage form OIL
Substance FLUOCINOLONE ACETONIDE
GPI-14 87300018101720
GCN Seq No 060055
GCN 26056
HICL code 033338
Ingredient (HICL) Fluocinolone Acetonide Oil
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q8
Therapeutic class — intermediate (HIC2) Otic Preparations
HIC3 code Q8P
Therapeutic class — specific (HIC3) Ear Preparations Anti-Inflammatory
AHFS code 52:08.08.00
AHFS class Corticosteroids (Eent)
FDB label name FLUOCINOLONE OIL 0.01% EAR DRP
FDB brand name Fluocinolone Acetonide Oil
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 70752-159-20 — 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 → 70752-0159-20. 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 Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids, Corticosteroids, potent (group III), Corticosteroids, plain
How it works Corticosteroid Hormone Receptor Agonists
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

LabelerQuagen Pharmaceuticals LLC
Application holderQUAGEN PHARMACEUTICALS LLC
FDA applicationANDA212762 (ANDA)
Labeler code70752
First marketedApr 2021
Product typeHuman Prescription Drug
Portfolio50 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 FLUOCINOLONE OIL 0.01% EAR DRP Ingredient Fluocinolone Acetonide Oil
📗 Our plain-language guide HelloPharmacist
  • It depends on the form you have. The topical oil, cream, and ointment forms treat skin inflammation — especially eczema (atopic dermatitis) — and other itchy or inflamed skin condi...
  • What is fluocinolone acetonide actually used for?
  • Tilt your head so the affected ear is pointing up, then gently pull your earlobe back and upward. Apply 5 drops and stay in that position for about a minute — this lets the oil wor...
  • Yes — don't apply it to your face, armpits, or groin unless your doctor specifically tells you to. Also avoid the diaper area in babies. These are sensitive spots where steroid abs...
📖 Read our full Fluocinolone 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.

🧪 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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 $0.953 $19.06 / 20 ml
Medicaid paysCMS SDUD · 12 mo $1.59 $31.76 / 20 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2023 Dec 2025 Apr 2026 Aug 2026 $1.320 $0.941
▼ Down 27% over the last 12 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
Fluocinolone Acetonide .11 mg/mL 45802-0009-10 Padagis 1 bottle $0.953 AT Availability likely —
Fluocinolone Acetonide Oil .11 mg/mL 64980-0329-20 Rising 20 ml $0.953 AT Availability likely —
Fluocinolone Acetonide .11 mg/mLthis 70752-0159-20 Quagen 1 bottle $0.953 AT Availability likely —
Dermotic .11 mg/mL 68791-0103-20 Royal 1 bottle $1.124 AT Availability likely +18%
Flac Otic Oil .11 mg/mL 39328-0079-20 Patrin 1 bottle $1.319 AT FDA listed +38%
fluocinolone acetonide .11 mg/mL 68462-0185-56 Glenmark 1 bottle $1.319 — FDA listed +38%
Fluocinolone Acetonide .11 mg/mL 71335-2879-01 Bryant 1 bottle — AT FDA listed —
Fluocinolone Acetonide .11 mg/mL 72162-2320-02 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

🏛️
2021
On the market since
Apr 2021
📍
2026
Currently FDA-listed
5 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 70752-0159-20, 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 – Q4 2025 · 4 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
5.6K
Units reimbursed last 4 qtrs
111.5K
Gross reimbursed last 4 qtrs
$177K
Avg / prescription
$31.88
Avg / unit
$1.5881
Latest quarter Q4 2025
1.9KRx
Medicaid pays / mL
$1.5881
gross reimbursed
vs
NADAC / mL
$0.9531
acquisition cost
=
Spread
+$0.6350
+67% 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 ⓘ
50% FFS 50% MCO
Fee-for-service · 2,752 Rx Managed care · 2,800 Rx
State Medicaid map
Alaska: no data reported AK Maine: 1,760 units · 126 per 100k residents ME Washington: 600 units · 7.7 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 220 units · 3.8 per 100k residents MN Wisconsin: 1,000 units · 16.9 per 100k residents WI Michigan: no data reported MI New York: 25,910 units · 132 per 100k residents NY Vermont: no data reported VT New Hampshire: 1,000 units · 71.3 per 100k residents 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: 8,220 units · 69.7 per 100k residents OH Pennsylvania: 3,940 units · 30.4 per 100k residents PA New Jersey: 1,400 units · 15.1 per 100k residents NJ Massachusetts: 11,420 units · 163 per 100k residents MA California: 480 units · 1.2 per 100k residents CA Utah: no data reported UT Colorado: 180 units · 3.1 per 100k residents CO Nebraska: no data reported NE Missouri: 1,060 units · 17.1 per 100k residents MO Kentucky: 1,840 units · 40.7 per 100k residents KY West Virginia: 480 units · 27.1 per 100k residents WV Virginia: 7,460 units · 85.6 per 100k residents VA Maryland: 2,380 units · 38.5 per 100k residents MD Connecticut: 16,960 units · 469 per 100k residents CT Rhode Island: 5,360 units · 489 per 100k residents RI Arizona: 240 units · 3.2 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: 4,380 units · 40.4 per 100k residents NC South Carolina: 4,400 units · 81.9 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 4,540 units · 99.3 per 100k residents LA Mississippi: no data reported MS Alabama: 440 units · 8.6 per 100k residents AL Georgia: 4,880 units · 44.2 per 100k residents GA D.C.: 280 units · 41.2 per 100k residents DC Hawaii: no data reported HI Texas: 640 units · 2.1 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
1.2489
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 Rhode Island 489 /100k
2 Connecticut 469 /100k
3 Massachusetts 163 /100k
4 New York 132 /100k
5 Maine 126 /100k
6 Louisiana 99.3 /100k
7 Virginia 85.6 /100k
8 South Carolina 81.9 /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 Fluocinolone Acetonide — the program that covers self-administered drugs. 8 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 Fluocinolone Acetonide. 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
$1.68M
Claims incl. refills
37.9K
Beneficiaries
30.7K
Spend / beneficiary
$54.73
Spend / claim
$44.40
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
70752-0159-20 You're viewing this 1 BOTTLE in 1 CARTON (70752-159-20) / 20 mL in 1 BOTTLE 2021-04-02 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 ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 32 words ▾

INDICATION AND USAGE Fluocinolone acetonide oil, 0.01% is a low to medium potency corticosteroid indicated for the treatment of chronic eczematous external otitis in adults and pediatric patients 2 years and older.

⏱️ Dosage and Administration 107 words ▾

DOSAGE AND ADMINISTRATION For the treatment of chronic eczematous external otitis, using the supplied ear-dropper, apply 5 drops of fluocinolone acetonide oil, 0.01% into the affected ear. To apply, tilt head to one side so that the ear is facing up. Then, gently pull the ear lobe backward and upward and apply 5 drops of fluocinolone acetonide oil, 0.01% into the ear.

Keep head tilted for about a minute to allow fluocinolone acetonide oil, 0.01% to penetrate lower into the ear canal. Gently pat excess material dripping out of the ear using a clean cotton ball. Follow these instructions twice each day for 7 to 14 days.

⛔ Contraindications 33 words ▾

CONTRAINDICATIONS Fluocinolone acetonide oil, 0.01% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. This product contains refined peanut oil NF (see PRECAUTIONS ).

🤒 Adverse Reactions 101 words ▾

ADVERSE REACTIONS The following local adverse reactions have been reported infrequently with topical corticosteroids. They may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria.

One peanut sensitive child experienced a flare of his atopic dermatitis after 5 days of twice daily treatment with fluocinolone acetonide oil, 0.01%. To report SUSPECTED ADVERSE REACTIONS, contact Quagen Pharmaceuticals LLC at 1-888-344-9603 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🆘 Overdosage 20 words ▾

OVERDOSAGE Topically applied fluocinolone acetonide oil, 0.01% can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).

🧬 Clinical Pharmacology 159 words ▾

CLINICAL PHARMACOLOGY Like other topical corticosteroids, fluocinolone acetonide has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A 2 inhibitory proteins, collectively called lipocortins.

It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A 2 . Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier.

Occlusion of topical corticosteroids can enhance penetration. Topical corticosteroids can be absorbed from normal intact skin. Also, inflammation and/or other disease processes in the skin can increase percutaneous absorption.

Fluocinolone acetonide oil, 0.01% is in the low to medium range of potency as compared with other topical corticosteroids.

📦 How Supplied / Storage and Handling 75 words ▾

HOW SUPPLIED Fluocinolone acetonide oil, 0.01% (ear drops) is supplied in a 1 fluid ounce bottle containing 20 mL net content (Dropper Included). (NDC # 70752-159-20). Keep tightly closed.

Store at 20°-25° C (68° to 77° F); excursions permitted to 15°-30° C (59°-86°F.) [see USP Controlled Room Temperature]. Discard fluocinolone acetonide oil, 0.01% (ear drops) 2 months after initial use. CAUTION: Rx only Manufactured for: Quagen Pharmaceuticals LLC West Caldwell, NJ 07006 52027 Rev.

04/21

📋 Description 151 words ▾

DESCRIPTION Fluocinolone acetonide oil, 0.01% (ear drops) contain fluocinolone acetonide {(6α, 11β, 16α)-6,9- difluoro-11,21-dihydroxy-16,17[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone}, a synthetic corticosteroid. This formulation is also marketed as fluocinolone acetonide topical oil, 0.01% (body oil) for the treatment of atopic dermatitis and fluocinolone acetonide topical oil, 0.01% (scalp oil) for the treatment of psoriasis of scalp. Chemically, fluocinolone acetonide is C 24 H 30 F 2 O 6 .

It has the following structural formula: Fluocinolone acetonide has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water. Each gram of fluocinolone acetonide oil, 0.01% (ear drops) contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF. structure

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70752-0158-06 · Quagen 70752-0161-10 · QUAGEN →
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.