HomeNDC LookupIngredientsDiclofenac Sodium › 52935-0006-01
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(from DailyMed)

Diclofenac Sodium 1 kg/kg Powder, 10 kg

by YUNG ZIP CHEMICAL INDUSTRIAL .CO., LTD. · 1 BAG in 1 DRUM (52935-0006-1) / 1 BAG in 1 BAG / 10 kg in 1 BAG
NDC 52935-0006-01
🏷️ FDA NDC (as labeled) 52935-0006-1 billing pads the package segment with a zero
This package
Contains10 kg Pack sizes3 compare ↓
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 Diclofenac Sodium (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 · Jan 27, 2026 — Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%. (SUN PHARMACEUTICAL INDUSTRIES INC) · FDA recall D-0342-2026
Class III · Dec 22, 2025 — Failed PH Specifications (Cipla USA, Inc.) · FDA recall D-0291-2026
Class II · Jun 22, 2023 — Defective Delivery System (ALEMBIC PHARMACEUTICALS, INC.) · FDA recall D-0941-2023
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 52935-0006-1
Product NDC 52935-0006
11-digit billing NDC 52935000601
SPL Set ID 04ab733f-76eb-24b4-e063-6294a90a1d6c
DEA schedule Non-controlled
Marketing category BULK INGREDIENT
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1980-09-04
Dosage form POWDER
Substance DICLOFENAC SODIUM
Why two NDCs? The FDA registers this code as 52935-0006-1 — 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 → 52935-0006-01. 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.

🏭 Manufacturer & labeler

LabelerYUNG ZIP CHEMICAL INDUSTRIAL .CO., LTD.
Labeler code52935
First marketedSep 1980
Product typeBulk Ingredient
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

📗 Our plain-language guide HelloPharmacist
  • An actinic keratosis — often just called an AK — is a rough, scaly patch on the skin caused by years of sun exposure. These patches are considered precancerous, meaning they could...
  • What exactly is an actinic keratosis, and why do I need a prescription gel for it?
  • The typical treatment course runs 60 to 90 days of twice-daily application — that's a solid commitment, but it's necessary for the gel to do its job. Here's the thing: even after y...
  • How long do I need to use this gel, and how will I know it's working?
📖 Read our full Diclofenac guide →
1
Nutrient depletion considerations

Diclofenac Sodium may be associated with lower levels of 1 nutrient — 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 25 kg 50 kg
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
Diclofenac Sodium 1 kg/kg 50335-0030-01 Henan 25 kg FDA listed
Diclofenac Sodium 1 kg/kgthis 52935-0006-01 YUNG 10 kg FDA listed
Diclofenac Sodium 1 kg/kg 48589-0005-00 Unique 50 kg FDA listed
Diclofenac Sodium 1 kg/kg 62512-0012-04 Amoli 50 kg FDA listed
Diclofenac Sodium 1 kg/kg 51927-0341-00 Professional 1 kg FDA listed
Diclofenac Sodium 1 kg/kg 58747-0406-00 Cheng 50 kg FDA listed
Diclofenac Sodium 1 kg/kg 79572-0014-01 Galenova 1 kg FDA listed
Diclofenac Sodium 1 kg/kg 46438-0629-00 Dipharma 50 kg FDA listed
Diclofenac Sodium 1 kg/kg 46438-0640-01 Dipharma 50 kg FDA listed
Diclofenac Sodium 1 kg/kg 51927-0005-00 Professional 1 kg FDA listed
Diclofenac Sodium 1 kg/kg 83221-0006-01 KREATIVE 25 kg FDA listed
Diclofenac Sodium 1 kg/kg 46438-0046-01 Dipharma 50 kg FDA listed
Diclofenac Sodium 1 kg/kg 54871-1084-00 Syn-Tech 50 kg FDA listed
Diclofenac sodium 1 kg/kg 17337-0409-00 Olon 50 kg FDA listed
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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

🏛️
1980
On the market since
Sep 1980
📍
2026
Currently FDA-listed
46 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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 Diclofenac Sodium (matched by generic name) — the program that covers self-administered drugs. 19 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 Diclofenac Sodium. CMS lists 3 products for this generic; we show the highest-spend one. 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
$30M
Claims incl. refills
804.1K
Beneficiaries
539.2K
Spend / beneficiary
$55.63
Spend / claim
$37.30
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 Diclofenac Sodium — the ingredient across all brands.

Top reported reactions

Pain15,671
Fatigue13,844
Arthralgia11,333
Rash10,855
Rheumatoid Arthritis10,744
Abdominal Discomfort9,636
Nausea9,507

Age at onset

Neonate343
Infant33
Child52
Adolescent148
Adult10,813
Elderly5,384

Reporter sex

155,962 reports
Male · 32%
Female · 68%
Unknown · 0%

Serious outcomes

Life-threatening12,256
Disabling11,529
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 20,254 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
52935-0006-01 You're viewing this 1 BAG in 1 DRUM (52935-0006-1) / 1 BAG in 1 BAG / 10 kg in 1 BAG Active
52935-0006-02 1 BAG in 1 DRUM (52935-0006-2) / 1 BAG in 1 BAG / 25 kg in 1 BAG Active
52935-0006-04 1 BAG in 1 DRUM (52935-0006-4) / 1 BAG in 1 BAG / 50 kg in 1 BAG Active

Pack size FAQ

What quantity is in NDC 52935-0006-01?
NDC 52935-0006-01 contains 10 kg — 1 bag in 1 drum / 1 bag in 1 bag / 10 kg in 1 bag.
What is the difference between NDC 52935-0006-01 and NDC 52935-0006-02?
Both are Diclofenac Sodium 1 kg/kg Powder — the drug itself is identical. NDC 52935-0006-01 is the 10 kg package, while NDC 52935-0006-02 is the 25 kg package.
What NDC number is used to bill for this package of Diclofenac Sodium 1 kg/kg Powder?
Bill NDC 52935-0006-01 — the 11-digit billing format is 52935000601. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Bulk ingredient (not a finished retail product)

This is a bulk ingredient listing — not a retail prescription package

Diclofenac Sodium 1 kg/kg POWDER is listed with FDA as a bulk ingredient (a drug substance supplied for further manufacturing or licensed pharmacy compounding). It is not a finished product a patient would receive at a retail pharmacy, so consumer-style information — a patient label, retail pricing, package photos — generally does not exist for this NDC. The listing identifies the substance and package for supply-chain and regulatory purposes.

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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Bulk Ingredient". Products approved under an application carry an NDA, ANDA, or BLA number.
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.
Can I get this product filled at a pharmacy?
Not as listed here. A bulk ingredient NDC identifies drug substance supplied for manufacturing or licensed compounding — it is not a finished, dispensable package. A pharmacy prescription would involve a finished product with its own NDC.
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 52935-0006-1, 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: 52935-0006-01, written without dashes as 52935000601. 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 52935-0006-01, the first segment (52935) is the labeler code FDA assigned to YUNG ZIP CHEMICAL INDUSTRIAL .CO., LTD.; the middle segment (0006) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 YUNG ZIP CHEMICAL INDUSTRIAL .CO., LTD.. 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 2 other package presentations of this same product, including 25 kg (52935-0006-02), 50 kg (52935-0006-04). 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?
YUNG ZIP CHEMICAL INDUSTRIAL .CO., LTD. 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.
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 FDA label FDA SPL

The complete FDA label for this product, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label 19 words

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

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.