Home › NDC Lookup › Ingredients › Hydrocortisone Acetate › 65649-0411-24
Anusol HC HYDROCORTISONE ACETATE 25 mg Suppository, 24 suppositories — NDC 65649-0411-24 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Anusol HC HYDROCORTISONE ACETATE 25 mg Suppository, 24 suppositories — NDC 65649-411-24 (Billing 65649-0411-24)

by Salix Pharmaceuticals, Inc · 24 SUPPOSITORY in 1 BOX

This is a package of 24 suppositories of Anusol HC HYDROCORTISONE ACETATE 25 mg Suppository from Salix Pharmaceuticals, Inc, marketed since Jun 2004 and currently FDA-listed.

NDC 65649-0411-24
🏷️ FDA NDC (as labeled) 65649-411-24 billing pads the product segment with a zero
This package
Contains24 suppositories Pack sizes2 compare ↓
Product page 65649-0411-12 Also comes in: 12 suppositories 65649-411-12
Rx only 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 65649-411-24 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
65649 labeler · 411 product · 24 package
Package marketed since
Jun 1, 2004
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
24 EA per package
Barcode (UPC)
0365649411120
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65649-411-24
Product NDC 65649-411
11-digit billing NDC 65649041124
NCPDP billing unit EA — each (per item)
RxCUI 1291082, 1291103
UNII 3X7931PO74
UPC 0365649411120
SPL Set ID a562f3d7-2692-4357-aade-ae50afcbfddd
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 2004-06-01
Route RECTAL
Dosage form SUPPOSITORY
Substance HYDROCORTISONE ACETATE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 89100010105230
GPI class Anusol-HC
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 ANUSOL-HC 25 MG SUPPOSITORY
FDB brand name Anusol-Hc
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 006858
  • GCN: 27941
  • GPI-14 (Medi-Span): 89100010105230
  • HICL (First Databank): 002863
  • AHFS class code: 84:06.08.00
  • RxCUI (RxNorm): 1291082
Why two NDCs? The FDA registers this code as 65649-411-24 — 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 → 65649-0411-24. 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.

Clinical

Label name ANUSOL-HC 25 MG SUPPOSITORY 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 depends on the product. Tablets and oral granules are used for adrenal insufficiency, among other conditions. Injections are used for severe allergic states and skin diseases. R...
  • Don't stop it suddenly if you take it for adrenal insufficiency. Stopping abruptly can cause adrenal crisis, which can be fatal. Talk to your prescriber before making any changes.
  • Common ones are fluid retention, higher blood pressure, changes in blood sugar, mood changes, bigger appetite and weight gain. Call your doctor for signs of infection, vision chang...
  • Grapefruit juice and some antifungals and antibiotics can raise hydrocortisone levels. Some seizure medicines and rifampicin can lower them. Tell me about any diabetes medicines, w...
📖 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.

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: 12 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
65649-0411-12 65649-411-12 Main listing 12 SUPPOSITORY in 1 BOX 2004-06-01 — Active
65649-0411-24 You're viewing this 24 SUPPOSITORY in 1 BOX 2004-06-01 — 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 24 suppositories — 24 suppository in 1 box.
How does this package differ from NDC 65649-0411-12?
Both are Anusol HC HYDROCORTISONE ACETATE 25 mg Suppository — the drug itself is identical. This page's package is the 24 suppositories one, while NDC 65649-0411-12 is the 12 suppositories package.
What NDC number is used to bill for this package of Anusol HC HYDROCORTISONE ACETATE 25 mg Suppository?
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
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 mgthis 65649-0411-24 Salix 24 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 mg 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

🏛️
2004
On the market since
Jun 2004
📍
2026
Currently FDA-listed
22 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.

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 Hydrocortisone 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 REK4960K2U
    Butylated hydroxyanisole is a synthetic preservative that prevents oils and fats in medicines from spoiling or becoming rancid. It keeps the medicine stable and extends its shelf life.
  • UNII 257THB963H
    A solid fat made from palm oil that has been chemically processed to increase stability. It functions as a binder and lubricant in tablets and capsules to help hold ingredients together and improve how the medicine flows during manufacturing.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.

3 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

LabelerSalix Pharmaceuticals, Inc
Labeler code65649
First marketedJun 2004
Product typeHuman Prescription Drug
Portfolio6 products on file

More NDCs from Salix Pharmaceuticals, Inc labeler code 65649

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.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 🤰 Pregnancy 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🔒 Drug Abuse and Dependence 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 31 words ▾

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

⏱️ Dosage and Administration 48 words ▾

DOSAGE AND ADMINISTRATION Usual Dosage: One suppository in the rectum morning and night for two weeks, in nonspecific proctitis. In more severe cases, one suppository three times daily; or two suppositories twice daily. In factitial proctitis, recommended therapy is six to eight weeks or less, according to response.

⛔ Contraindications 19 words ▾

CONTRAINDICATION Anusol-HC ® suppositories are contraindicated in those patients with a history of hypersensitivity to any of the components.

🤒 Adverse Reactions 49 words ▾

ADVERSE REACTIONS The following local adverse reactions have been reported with corticosteroid suppositories. 1. Burning 2. Itching 3. Irritation 4. Dryness 5. Folliculitis 6. Hypopigmentation 7. Allergic contact dermatitis 8. Secondary infection To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🤰 Pregnancy 143 words ▾

Pregnancy: In laboratory animals, topical steroids have been associated with an increase in the incidence of fetal abnormalities when gestating females have been exposed to rather low dosage levels. There are no adequate and well-controlled studies in pregnant women. Anusol-HC ® suppositories should only be used during pregnancy if the potential benefit justifies the risk of the fetus.

Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time. Nursing Mothers: It is not known whether this drug is excreted in human milk, and because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Anusol-HC ® suppositories, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

🆘 Overdosage 11 words ▾

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

🧬 Clinical Pharmacology 47 words ▾

CLINICAL PHARMACOLOGY In normal subjects, about 26 percent of hydrocortisone acetate is absorbed when the hydrocortisone acetate 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 133 words ▾

HOW SUPPLIED Anusol-HC ® 25 mg Suppositories are white, cylinder shaped, with one end tapered. NDC 65649-411-12 25 mg 12 suppositories NDC 65649-411-24 25 mg 24 suppositories Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store away from heat.

PROTECT FROM FREEZING. Distributed by: Salix Pharmaceuticals, a division of Bausch Health US, LLC, Bridgewater, NJ 08807 USA Anusol-HC is a trademark of Salix Pharmaceuticals, Inc. or its affiliates. © 2024 Salix Pharmaceuticals, Inc. or its affiliates OPENING INSTRUCTIONS Avoid excessive handling of the suppository. It is designed to melt at body temperature.

1. Separate plastic film at top opening and pull downward. 2.

Continue pulling downward to almost the full length of the suppository. 3. Gently remove the suppository from the film pocket.

Rev. 07/2024 9520702 Opening Instructions

📋 Description 39 words ▾

DESCRIPTION Each Anusol-HC ® 25 mg Suppository contains 25 mg hydrocortisone acetate in a hydrogenated vegetable oil base. Hydrocortisone acetate is a corticosteroid. Chemically, hydrocortisone acetate is pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy (11β)- with the following structural formula: Structural Formula

💬 Information for Patients 17 words ▾

Information for Patients: Staining of fabric may occur with use of the suppository. Precautionary measures are recommended.

⚠️ Precautions 76 words ▾

PRECAUTIONS Do not use unless adequate proctologic examination is made. If irritation develops, the product should be discontinued and appropriate therapy instituted. In the presence of an infection, the use of an appropriate antifungal or antibacterial agent should be instituted.

If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled. No long-term studies in animals have been performed to evaluate the carcinogenic potential of corticosteroid suppositories.

🔒 Drug Abuse and Dependence 19 words ▾

DRUG ABUSE AND DEPENDENCE Drug abuse and dependence has not been reported in patients treated with Anusol-HC ® suppositories.

📄 Package Label / Principal Display Panel 34 words ▾

PACKAGE LABEL PRINCIPAL DISPLAY PANEL - Carton NDC 65649-411-12 Rx only Anusol-HC ® (Hydrocortisone Acetate in a Hydrogenated Vegetable Oil Base) 25 mg For rectal use only. Not for oral use. 12 Suppositories carton

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 Anusol-HC — 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 Anusol-HC. 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
$5.7K
Claims incl. refills
31
Beneficiaries
30
Spend / beneficiary
$191.60
Spend / claim
$185.42
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 Anusol HC (this brand).

Top reported reactions

Fatigue7,340
Condition Aggravated6,496
Rash6,232
Pain5,859
Nausea5,631
Arthralgia5,214
Diarrhoea5,153

Age at onset

Neonate341
Infant319
Child1,072
Adolescent713
Adult8,638
Elderly3,623

Reporter sex

71,324 reports
Male · 41%
Female · 59%
Unknown · 0%

Serious outcomes

Hospitalization30,362
Death10,706
Life-threatening9,676
Disabling6,928
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 7,040 2,956
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 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 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 Salix Pharmaceuticals, 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 12 suppositories (65649-0411-12). 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?
Salix Pharmaceuticals, 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.
← 65649-0401-30 · Salix 65649-0501-30 · Salix →
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.