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Fluocinonide .5 mg/mL Solution, 60 mL — NDC 70771-1375-3 (Billing 70771-1375-03)

by Zydus Lifesciences Limited · 60 mL in 1 BOTTLE

This is a package of 60 mL of Fluocinonide .5 mg/mL Solution from Zydus Lifesciences Limited, marketed since Nov 2018 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 70771-1375-03
🏷️ FDA NDC (as labeled) 70771-1375-3 billing pads the package segment with a zero
This package
Contains60 mL Pack sizes2 compare ↓
Also priced by: Part D plans $0.4094/unit — full pricing hub ↓
Main listing for product 70771-1375 · Also comes in: 20 ml 70771-1375-8
Rx only Generic 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

NDC database record

One package, one record: these facts belong to NDC 70771-1375-3 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
70771 labeler · 1375 product · 3 package
Package marketed since
Nov 1, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7077113753 4
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Fluocinonide (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 25, 2026 — Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing. (SUN PHARMACEUTICAL INDUSTRIES INC) · FDA recall D-0476-2026
Class II · Mar 25, 2026 — Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing. (SUN PHARMACEUTICAL INDUSTRIES INC) · FDA recall D-0477-2026
Class II · Mar 25, 2026 — Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing. (SUN PHARMACEUTICAL INDUSTRIES INC) · FDA recall D-0475-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70771-1375-3
Product NDC 70771-1375
11-digit billing NDC 70771137503
RxCUI 310364
UNII 2W4A77YPAN
Application # ANDA208948
SPL Set ID 72b19e31-49e8-4bd7-8205-997f0c6a43f1
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 2018-11-01
Route TOPICAL
Dosage form SOLUTION
Substance FLUOCINONIDE
TE code (Orange Book) AT · RLD · RS
Quick answers
  • RxCUI (RxNorm): 310364
Why two NDCs? The FDA registers this code as 70771-1375-3 — a 5-4-1 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 package segment → 70771-1375-03. 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)
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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It calms redness, swelling and itching from skin conditions that respond to steroids. The 0.1% creams, including Vanos, are for people 12 and older, and the label specifically desc...
  • Use a thin layer on the affected skin only. Follow the schedule on your label and from your prescriber, which differs between the 0.1% creams and the 0.05% products. Don't cover th...
  • No. The 0.1% creams are not for the face, groin or underarms. Also keep all of it out of your eyes, mouth and vagina.
  • The 0.1% creams are not recommended beyond 2 consecutive weeks. Stop once the condition is controlled, and tell your doctor if you see no improvement in 2 weeks.
📖 Read our full Fluocinonide 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 mLPer 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 $0.4094 $24.56 / 60 ml
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
70771-1375-03 You're viewing this Main listing 60 mL in 1 BOTTLE 2018-11-01 — Active
70771-1375-08 70771-1375-8 20 mL in 1 BOTTLE 2018-11-01 — Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 60 mL — 60 ml in 1 bottle.
How does this package differ from NDC 70771-1375-08?
Both are Fluocinonide .5 mg/mL Solution — the drug itself is identical. This page's package is the 60 mL one, while NDC 70771-1375-08 is the 20 ml package.
What NDC number is used to bill for this package of Fluocinonide .5 mg/mL Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
fluocinonide .5 mg/mL 00168-0134-60 E. 1 bottle $0.205 AT Availability likely —
Fluocinonide .5 mg/mL 21922-0001-01 Encube 1 bottle $0.205 AT Availability likely —
Fluocinonide .5 mg/mL 70710-1284-03 Zydus 60 ml $0.205 AT Availability likely —
Fluocinonide .5 mg/mL 70752-0154-05 QUAGEN 1 bottle $0.205 AT Availability likely —
Fluocinonide .5 mg/mL 72603-0703-01 NorthStar 1 bottle $0.205 AT Availability likely —
Fluocinonide .5 mg/mL 33342-0320-84 Macleods 1 bottle $0.314 AT Availability likely —
Fluocinonide .5 mg/mL 43386-0026-02 Lupin 1 bottle $0.314 AT Availability likely —
Fluocinonide .5 mg/mL 51672-1273-02 Sun 1 bottle $0.314 AT Availability likely —
fluocinonide .5 mg/mL 40032-0026-06 Novel 1 bottle — AT FDA listed —
Fluocinonide .5 mg/mL 63629-9583-01 Bryant 1 bottle — AT FDA listed —
Fluocinonide .5 mg/mL 68071-3918-06 NuCare 1 bottle — AT FDA listed —
Fluocinonide .5 mg/mLthis 70771-1375-03 Zydus 60 ml — AT FDA listed —
Fluocinonide .5 mg/mL 71656-0094-20 Saptalis 20 ml — AT FDA listed —
Fluocinonide .5 mg/mL 72162-1270-06 Bryant 1 bottle — AT FDA listed —
fluocinonide .5 mg/mL 72162-2146-06 Bryant 1 bottle — AT FDA listed —
Fluocinonide .5 mg/mL 72162-2490-02 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

🏛️
2018
On the market since
Nov 2018
📍
2026
Currently FDA-listed
8 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.

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.

🧪 Avoiding an ingredient? See Fluocinonide inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 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 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII P7E6YFV72X
    Diisopropyl adipate is a clear, oily liquid derived from adipic acid. It acts as a plasticizer and solvent in medicines, helping soften coatings and improve how the drug dissolves or spreads in the body.
  • 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.
  • 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.

5 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

LabelerZydus Lifesciences Limited
Application holderZYDUS PHARMACEUTICALS USA INC
FDA applicationANDA208948 (ANDA)
Labeler code70771
First marketedNov 2018
Product typeHuman Prescription Drug
Portfolio720 products on file

More NDCs from Zydus Lifesciences Limited labeler code 70771

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.
📄 Package Label / Principal Display Panel
📄 Package Label / Principal Display Panel 26 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1375-8 Fluocinonide topical solution USP, 0.05% Rx only 20 mL Fluocinonide topical solution USP, 0.5% image Fluocinonide topical solution USP, 0.05%

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Fluocinonide — the program that covers self-administered drugs. 13 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 Fluocinonide. 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
$6.96M
Claims incl. refills
176.2K
Beneficiaries
135.8K
Spend / beneficiary
$51.22
Spend / claim
$39.49
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.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Fluocinonide — the ingredient across all brands.

Top reported reactions

Psoriasis546
Rash454
Pruritus426
Fatigue288
Diarrhoea285
Nausea275
Pain273

Age at onset

Infant3
Child69
Adolescent77
Adult980
Elderly477

Reporter sex

5,595 reports

Serious outcomes

Hospitalization1,022
Death259
Disabling99
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 438 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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) — 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 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 Zydus Lifesciences Limited. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 20 ml (70771-1375-08). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Zydus Lifesciences 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.
← 70771-1374-03 · Zydus 70771-1380-01 · Zydus →
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.