NDC 82393-0209-04 — Clonidine HCl 1 kg/kg Powder, 001 kg

🆔 Identity & classification

FDA NDC (as labeled) 82393-209-04

Product NDC 82393-209

11-digit billing NDC 82393020904

SPL Set ID 0805b6b4-9f27-2c3c-e063-6394a90a196e

DEA schedule Non-controlled

Marketing category BULK INGREDIENT

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2022-04-14

Dosage form POWDER

Substance CLONIDINE HYDROCHLORIDE

GPI-14 36201010102900

GPI class cloNIDine HCl

GCN Seq No 022511

GCN 70381

HICL code 000113

Ingredient (HICL) Clonidine Hcl

HIC1 code U

Therapeutic class — broad (HIC1) Miscell. Drugs/ Pharmaceutical Adjuvants

HIC2 code U6

Therapeutic class — intermediate (HIC2) Pharmaceutical Adjuvants

HIC3 code U6W

Therapeutic class — specific (HIC3) Bulk Chemicals

AHFS code 12:12.04.00

AHFS class Alpha-Adrenergic Agonists (12:12)

FDB label name CLONIDINE HCL POWDER

FDB brand name Clonidine Hcl

Legend status F — Federal legend — prescription drug or device

Why two NDCs? The FDA registers this code as 82393-209-04 — 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 → 82393-0209-04. 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

LabelerPharma Source Direct, Inc.

Labeler code82393

First marketedApr 2022

Product typeBulk Ingredient

Portfolio62 products on file

🔎 All NDCs from Pharma Source Direct, Inc.

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 CLONIDINE HCL POWDER Ingredient Clonidine Hcl

📗 Our plain-language guide HelloPharmacist

You're right that it's used for several different conditions — that can be confusing. Depending on the product, clonidine is prescribed to lower high blood pressure in adults, to t...
What exactly is clonidine used for — I've seen it mentioned for totally different things?
Drowsiness is one of the most common side effects, especially when you first start or when your dose goes up. Many people find it eases a bit over time. Until you know how it affec...
Will clonidine make me too sleepy to function?

📖 Read our full Clonidine guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

1

Nutrient depletion considerations

Clonidine may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

COENZYME Q10 Insufficient Evidence

🧪 Full Clonidine 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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.

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 system	Per g	Per 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: 1 kg 005 kg 025 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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
CLONIDINE HCl 1 kg/kg 51014-7543-00	PCAS	30 kg	—	—	FDA listed	—
Clonidine HCl 1 kg/kgthis 82393-0209-04	Pharma	001 kg	—	—	FDA listed	—
Clonidine HCl 1 kg/kg 12660-0002-01	Societa	25 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

🏛️

2022

On the market since

Apr 2022

📍

2026

Currently FDA-listed

4 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 Clonidine HCl (matched by generic name) — the program that covers self-administered drugs. 10 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 Clonidine HCl. CMS lists 4 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

$5.9M

Claims incl. refills

849.1K

Beneficiaries

545.6K

Spend / beneficiary

$10.81

Spend / claim

$6.94

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 NDC	Description	Marketing start	Status
82393-0209-04 You're viewing this	.001 kg in 1 BOTTLE, PLASTIC (82393-209-04)	—	Active
82393-0209-05	.005 kg in 1 BOTTLE, PLASTIC (82393-209-05)	—	Active
82393-0209-07	.025 kg in 1 BOTTLE, PLASTIC (82393-209-07)	—	Active
82393-0209-08	.1 kg in 1 BOTTLE, PLASTIC (82393-209-08)	—	Active

Pack size FAQ

What quantity is in NDC 82393-0209-04?

NDC 82393-0209-04 contains 001 kg — .001 kg in 1 bottle, plastic.

What is the difference between NDC 82393-0209-04 and NDC 82393-0209-08?

Both are Clonidine HCl 1 kg/kg Powder — the drug itself is identical. NDC 82393-0209-04 is the 001 kg package, while NDC 82393-0209-08 is the 1 kg package.

What NDC number is used to bill for this package of Clonidine HCl 1 kg/kg Powder?

Bill NDC 82393-0209-04 — the 11-digit billing format is 82393020904. 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

Clonidine HCl 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 82393-209-04, 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: 82393-0209-04, written without dashes as 82393020904. 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 82393-0209-04, the first segment (82393) is the labeler code FDA assigned to Pharma Source Direct, Inc.; the middle segment (0209) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 Pharma Source Direct, Inc.. 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 3 other package presentations of this same product, including 1 kg (82393-0209-08), 005 kg (82393-0209-05), 025 kg (82393-0209-07). 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?

Pharma Source Direct, Inc. 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

📄 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 ↗

🔗 Related NDC lookups

🧪 All Clonidine Hcl NDCsSame ingredient 🏭 All Pharma labeler NDCsLabeler code 82393

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Bulk Chemicals.

Papaverine Hcl 10695-0116-10 Dihydroergotamine Mesylate 38779-0303-03 Diazoxide 38779-0324-03 Beclomethasone Dipropionate 38779-0364-01 Caffeine 38779-0419-05 Enalapril Maleate 38779-0514-04 Minoxidil 38779-0574-01 Ergoloid Mesylates 38779-0860-03 Alprostadil 38779-0944-06 Theophylline Anhydrous 38779-1816-01 Hydralazine Hcl 49452-3544-01 Quinidine Sulfate 49452-6180-01 Verapamil Hcl 51552-0525-04 Dipyridamole 51927-1571-00 Mexiletine Hcl 51927-2953-00

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.