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Hydrocortisone Acetate 25 mg Suppository, 12 suppositories — NDC 82568-0150-01 package photo

Hydrocortisone Acetate 25 mg Suppository, 12 suppositories

by AARNA USA INC. · 12 SUPPOSITORY in 1 CARTON (82568-0150-1)
NDC 82568-0150-01
🏷️ FDA NDC (as labeled) 82568-0150-1 billing pads the package segment with a zero
This package
Contains12 suppositories Pack sizes2 compare ↓
Also comes in: 24 suppositories 82568-0150-02
Rx only 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

🆔 Identity & classification

FDA NDC (as labeled) 82568-0150-1
Product NDC 82568-0150
11-digit billing NDC 82568015001
NCPDP billing unit EA — each (per item)
RxCUI 1291082, 1291085
UNII 3X7931PO74
UPC 0382568016014
SPL Set ID 4f9709ed-4818-3d3b-e063-6394a90a0d04
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-04-16
Route RECTAL
Dosage form SUPPOSITORY
Substance HYDROCORTISONE ACETATE
GPI-14 89100010105230
GCN Seq No 006858
GCN 27941
HICL code 002863
Ingredient (HICL) Hydrocortisone Acetate
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q3
Therapeutic class — intermediate (HIC2) Anal-Rectal Preparations
HIC3 code Q3A
Therapeutic class — specific (HIC3) Rectal Preparations
AHFS code 84:06.08.00
AHFS class Corticosteroids (Skin, Mucous Membrane)
FDB label name HYDROCORTISONE AC 25 MG SUPP
FDB brand name Hydrocortisone Acetate
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 82568-0150-1 — 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 → 82568-0150-01. 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.

🏷️ RxNorm drug class

This medicine belongs to the Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids, moderately potent (group II), Corticosteroids, potent (group III), Corticosteroids for local oral treatment
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

LabelerAARNA USA INC.
Labeler code82568
First marketedApr 2026
Product typeHuman Prescription Drug
Portfolio19 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 HYDROCORTISONE AC 25 MG SUPP Ingredient Hydrocortisone Acetate
📖 What it is MedlinePlus · NLM

Rectal hydrocortisone is used along with other medications to treat proctitis (swelling in the rectum) and ulcerative colitis (a condition which causes swelling and sores in the lining of the large intestine and rectum). It is also used to relieve itching and swelling from hemorrhoids and other rectal problems. Hydrocortisone is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It's designed to calm down inflammation — so the redness, swelling, and itching that come with conditions like eczema should ease up, usually within a few days of consistent use. I...
  • What exactly is this cream supposed to do for my skin?
  • That's a really important question. Hydrocortisone is generally meant for short courses — typically a few weeks. Long-term or widespread use can cause side effects like skin thinni...
  • How long can I keep using it? Is it okay to use every day long-term?
📖 Read our full Hydrocortisone guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
8
Nutrient depletion considerations

Hydrocortisone may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Hydrocortisone 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.

💊 What it looks like

Color white
ShapeBullet
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 FM8D1RE2VP
    A plant-based oil that has been chemically hardened to stay solid at room temperature. It works as a binder and lubricant to hold tablet ingredients together and help them release properly during digestion.

1 inactive ingredient 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 eachPer 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: 24 suppositories
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
Hydrocortisone Acetate 25 mg 24689-0102-01 APNAR 12 suppositories $1.101 — FDA listed —
Hydrocortisone Acetate 25 mg 00574-7090-12 Padagis 12 suppositories — — FDA listed —
Anucort-Hc 25 mg 00713-0503-01 Cosette 100 suppositories — — FDA listed —
Hydrocortisone Acetate 25 mg 00904-7340-12 Major 12 suppositories — — FDA listed —
Hydrocortisone Acetate 25 mg 10135-0751-12 Marlex 12 suppositories — — FDA listed —
Hemmorex-HC 25 mg 16477-0201-12 Laser 12 suppositories — — FDA listed —
Hydrocortisone Acetate 25 mg 16571-0676-21 Rising 12 suppositories — — FDA listed —
Hydrocortisone Acetate 25 mg 39328-0029-12 Patrin 12 suppositories — — FDA listed —
Hydrocortisone Acetate 25 mg 50090-6331-00 A-S 12 suppositories — — FDA listed —
Hydrocortisone Acetate 25 mg 50268-0411-01 AvPAK 100 suppositories — — FDA listed —
Hydrocortisone Acetate 25 mg 51407-0665-12 Golden 12 suppositories — — FDA listed —
Hydrocortisone Acetate 25 mg 63629-2530-01 Bryant 12 suppositories — — FDA listed —
Anusol HC 25 mg 65649-0411-12 Salix 12 suppositories — — FDA listed —
Hydrocortisone Acetate 25 mg 68071-2259-02 NuCare 12 suppositories — — FDA listed —
Hydrocortisone Acetate 25 mg 69367-0243-12 Westminster 12 suppositories — — FDA listed —
Hydrocortisone Acetate 25 mg 70752-0169-02 QUAGEN 12 suppositories — — FDA listed —
Hydrocortisone Acetate 25 mg 71205-0976-12 Proficient 12 suppositories — — FDA listed —
Hydrocortisone Acetate 25 mg 75834-0147-12 Nivagen 12 suppositories — — FDA listed —
Hydrocortisone Acetate 25 mgthis 82568-0150-01 AARNA 12 suppositories — — FDA listed —
Hydrocortisone Acetate 25 mg 68788-4190-01 Preferred 12 suppositories — — 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

🏛️
2026
On the market since
Apr 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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 Hydrocortisone Acetate — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Hydrocortisone Acetate. 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
$497.1K
Claims incl. refills
345
Beneficiaries
236
Spend / beneficiary
$2,106.25
Spend / claim
$1,440.80
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
82568-0150-01 You're viewing this 12 SUPPOSITORY in 1 CARTON (82568-0150-1) 2026-04-16 Active
82568-0150-02 24 SUPPOSITORY in 1 CARTON (82568-0150-2) 2026-04-16 Active

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

Pack size FAQ

What quantity is in NDC 82568-0150-01?
NDC 82568-0150-01 contains 12 suppositories — 12 suppository in 1 carton.
What is the difference between NDC 82568-0150-01 and NDC 82568-0150-02?
Both are Hydrocortisone Acetate 25 mg Suppository — the drug itself is identical. NDC 82568-0150-01 is the 12 suppositories package, while NDC 82568-0150-02 is the 24 suppositories package.
What NDC number is used to bill for this package of Hydrocortisone Acetate 25 mg Suppository?
Bill NDC 82568-0150-01 — the 11-digit billing format is 82568015001. 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

Finished prescription product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

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 — 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 "Unapproved Drug Other". 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.
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 82568-0150-1, 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: 82568-0150-01, written without dashes as 82568015001. 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 82568-0150-01, the first segment (82568) is the labeler code FDA assigned to AARNA USA INC.; the middle segment (0150) 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 AARNA USA 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 1 other package presentation of this same product, including 24 suppositories (82568-0150-02). 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?
AARNA USA 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.
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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description
🎯 Indications and Usage 35 words ▾

INDICATIONS AND USAGE Hydrocortisone acetate suppositories are indicated for use in inflamed hemorrhoids, post-irradiation (factitial) proctitis, as an adjunct in the treatment of chronic ulcerative colitis, cryptitis, other inflammatory conditions of anorectum, and pruritus ani.

⏱️ Dosage and Administration 115 words ▾

DOSAGE AND ADMINISTRATION FOR RECTAL ADMINISTRATION Detach one suppository from strip of suppositories. Hold suppository upright and carefully separate tabs at top opening and pull downward from the pointed end to expose the suppository. Remove the suppository from the pocket.

Avoid excessive handling of suppository which is designed to melt at body temperature. Insert one suppository rectally, pointed end first. Insert one suppository in the rectum twice daily, morning and night for two weeks, in nonspecific proctitis.

In more severe cases, one suppository three times a day or two suppositories twice daily. In factitial proctitis, the recommended duration of therapy is six to eight weeks or less, according to the response of the individual case.

⛔ Contraindications 22 words ▾

CONTRAINDICATIONS Hydrocortisone acetate suppositories are contraindicated in those patients having a history of hypersensitivity to hydrocortisone acetate or any of the components.

🤒 Adverse Reactions 37 words ▾

ADVERSE REACTIONS The following local adverse reactions have been reported with hydrocortisone acetate suppositories; burning, itching, irritation, dryness, folliculitis, hypopigmentation, allergic contact dermatitis, secondary infection. To report an adverse event, please contact AARNA USA INC at 1-877-225-6999.

🆘 Overdosage 11 words ▾

OVERDOSAGE If signs and symptoms of systemic overdosage occur, discontinue use.

🧬 Clinical Pharmacology 44 words ▾

CLINICAL PHARMACOLOGY In normal subjects, about 26% of hydrocortisone acetate is absorbed when the suppository is applied to the rectum. Absorption of hydrocortisone acetate may vary across abraded or inflamed surfaces. Topical steroids are primarily effective because of their anti-inflammatory, anti-pruritic and vasoconstrictive action.

📦 How Supplied / Storage and Handling 188 words ▾

HOW SUPPLIED Hydrocortisone acetate suppositories 25mg are off-white, smooth surfaced and bullet shaped with one pointed end. Box of 12 suppositories, NDC 82568-0150-1 Box of 24 suppositories, NDC 82568-0150-2 Hydrocortisone acetate suppositories 30mg are off-white, smooth surfaced and bullet shaped with one pointed end. Box of 12 suppositories, NDC 82568-0160-1 STORAGE Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

Excursions permitted to 15°- 30°C (59°-86°F). Store away from heat. Protect from freezing.

Avoid contact with eyes. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. PHARMACIST: This product is not an Orange Book rated product, therefore all prescriptions using this product shall be subject to state and federal statutes as applicable.

This product has not been subjected to FDA therapeutic or other equivalency testing. There are no claims of bioequivalence or therapeutic equivalence. Each person recommending a prescription substitution using this product shall make such recommendation based on his/her professional knowledge and opinion, upon evaluating the active ingredients, inactive ingredients, excipients and chemical information contained within the enclosed prescribing information.

📦 Storage and Handling 27 words ▾

STORAGE Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Excursions permitted to 15°- 30°C (59°-86°F). Store away from heat. Protect from freezing. Avoid contact with eyes.

📋 Description 60 words ▾

DESCRIPTION Hydrocortisone acetate is a corticosteroid designed chemically as pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β) with the following structural formula: Each 25 mg suppository for rectal administration contains hydrocortisone acetate, USP 25 mg in a specially blended hydrogenated vegetable base. Each 30 mg suppository for rectal administration contains hydrocortisone acetate, USP 30 mg in a specially blended hydrogenated vegetable base. Chemical Structure

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 82568-0051-01 · AARNA 82568-0152-06 · AARNA →
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.