NDC 45802-0042-02 — Clindesse clindamycin phosphate 100 mg/5g

🆔 Identity & classification

FDA NDC (as labeled) 45802-042-02

Product NDC 45802-042

11-digit billing NDC 45802004202

RxCUI 309337, 602427

UNII EH6D7113I8

Application # NDA050793

SPL Set ID fe8bb204-f173-44fe-803b-b08f2ec5aa31

Established class (EPC) Lincosamide Antibacterial

Physiologic effect Decreased Sebaceous Gland Activity; Neuromuscular Blockade

Chemical class Lincosamides

DEA schedule Non-controlled

Marketing category NDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2015-07-03

Route VAGINAL

Dosage form CREAM

Substance CLINDAMYCIN PHOSPHATE

GPI-14 55100018113720

GPI class Clindesse

GCN Seq No 058439

GCN 23876

HICL code 004045

Ingredient (HICL) Clindamycin Phosphate

HIC1 code Q

Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other

HIC2 code Q4

Therapeutic class — intermediate (HIC2) Vaginal Preparations

HIC3 code Q4W

Therapeutic class — specific (HIC3) Vaginal Antibiotics

AHFS code 08:12.28.20

AHFS class Lincomycin Antibiotics

FDB label name CLINDESSE 2% VAGINAL CREAM

FDB brand name Clindesse

Legend status F — Federal legend — prescription drug or device

Why two NDCs? The FDA registers this code as 45802-042-02 — 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 → 45802-0042-02. 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 Lincosamide Antibacterial class.

Pharmacologic class Lincosamide Antibacterial

Drug family (ATC) Antiinfectives for treatment of acne, Antibiotics, Lincosamides

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

LabelerPadagis Israel Pharmaceuticals Ltd

Application holderPADAGIS US LLC

FDA applicationNDA050793 (NDA)

Labeler code45802

First marketedJul 2015

Product typeHuman Prescription Drug

Portfolio175 products on file

🔎 All NDCs from Padagis Israel Pharmaceuticals Ltd

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 CLINDESSE 2% VAGINAL CREAM Ingredient Clindamycin Phosphate

📖 What it is MedlinePlus · NLM

Vaginal clindamycin is used to treat bacterial vaginosis (an infection caused by harmful bacteria in the vagina). Clindamycin is in a class of medications called lincomycin antibiotics. It works by slowing or stopping the growth of bacteria. Vaginal clindamycin is not used to treat vaginal irritation caused by yeast infections or by sexually transmitted diseases such as chlamydia and trichomoniasis.

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

Bacterial vaginosis (BV) is not a sexually transmitted infection in the traditional sense — it's an overgrowth of certain bacteria that naturally live in the vagina, causing an imb...
What is the vaginal cream actually treating — is bacterial vaginosis an STI?
No — and this is really important. The Clindesse vaginal cream contains mineral oil, which can break down latex. That means condoms and diaphragms may not protect you from pregnanc...
Can I use a condom or diaphragm while using the vaginal cream?

📖 Read our full Clindamycin Topical guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

7

Nutrient depletion considerations

Clindamycin may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

BIOTIN Insignificant Depletion FOLIC ACID Insignificant Depletion RIBOFLAVIN Insignificant Depletion THIAMINE Insignificant Depletion VITAMIN B12 Insignificant Depletion +2 more

🧪 Full Clindamycin 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

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 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
UNII HYE7O27HAO
Glyceryl isostearate is a fatty substance derived from vegetable oils or animal fats. In medicines, it acts as an emulsifier to blend water and oil components together, and helps form a smooth texture in creams, ointments, and other topical products.
UNII 1DI56QDM62
A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
UNII XOF597Q3KY
A refined form of wax made from petroleum, microcrystalline wax is used in medicines as a coating agent, binder, and hardening ingredient. It helps give tablets and capsules their shape and protective outer layer.
UNII T5L8T28FGP
Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
UNII XRQ165498B
A plant-derived emulsifier made from glycerin and oleic acid. It helps mix oil and water-based ingredients together in the formulation and improves product texture and stability.
UNII Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
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.
UNII 506T60A25R
Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
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.

11 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.

💲 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 · Q2 2026	$26.64	$133.22 / 5 g

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
Cleocin 20 mg/g 00009-3448-01	Pharmacia	1 tube	$1.789	AB	Availability likely	—
Clindamycin Phosphate 20 mg/g 00168-0277-40	E.	40 g	$1.834	AB	Availability likely	—
clindamycin phosphate 20 mg/g 59762-5009-01	Mylan	1 tube	$1.834	AB	Availability likely	—
Xaciato 100 mg/5g 78206-0189-01	Organon	1 tube	$18.925	—	Availability likely	—
Clindesse 100 mg/5gthis 45802-0042-02	Padagis	1 applicator	—	—	FDA listed	—

About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be 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

First FDA approval

Nov 2004

📍

2026

Currently FDA-listed

22 years listed

🛡️

2026

Latest patent/protection listed

not a guaranteed launch date

✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Dec 2026. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.

📅 FDA approved Nov 30, 2004 RLD RS ⏳ ~0.2 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book

US 9789057 — method of use (U-137)

2004 2006 2008 2010 2012 2014 2016 2018 2020 2022 2024 2026

Today

LOE

Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo

🏛️FDA exclusivity

FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.

🧪Product / substance patents

Patents covering the active ingredient, product, formulation, or related drug features.

🎯Method-of-use patents

Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.

🛈 What do these terms mean?

Patent: Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent: Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent: Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent: A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label: A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity: FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV: A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS: Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating: FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity): The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (1)

Patent	Type	Use code	Expires
US 9789057 ↗	Method of use	U-137	Dec 2, 2026

Common questions

Is there a generic version of CLINDESSE 2% VAGINAL CREAM?

Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for CLINDESSE 2% VAGINAL CREAM. See the alternatives section for substitutable, lower-cost products.

The FDA approved a generic — why can’t I get it at my pharmacy yet?

FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.

Why do different websites show different generic release dates?

Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.

What does “FDA listed” mean?

It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.

What does a patent or protection date mean here?

It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).

What does “current Orange Book estimate” mean?

It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.

Can a generic come out before the last patent expires?

Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.

Can a generic come out after the listed dates?

Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.

What is the difference between patents and exclusivity?

Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.

Why are there multiple patent dates?

One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.

Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.

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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.

1 applicator45802-0042-01 1,843 Rx · $378,071

1 applicator this page45802-0042-02 No Medicaid data

Drug total (last 4 qtrs): 1,843 Rx · 15,662 units · $378,071 gross reimbursed

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Clindesse — 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 Clindesse. 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

$7.3K

Claims incl. refills

41

Beneficiaries

37

Spend / beneficiary

$197.16

Spend / claim

$177.92

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 Clindesse (this brand).

Top reported reactions

Rash254

Drug Hypersensitivity228

Diarrhoea190

Nausea189

Pain179

Fatigue172

Pruritus163

Age at onset

Neonate11

Infant5

Child12

Adolescent40

Adult331

Elderly114

Reporter sex

Male · 34%

Female · 66%

Unknown · 0%

Serious outcomes

Hospitalization1,065

Death268

Life-threatening210

Disabling77

Reports over time (by year) — tap or hover for the count & year

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 NDC	Description	Per unit	Per pack	Marketing start	Status
45802-0042-01	1 APPLICATOR in 1 CARTON (45802-042-01) / 5 g in 1 APPLICATOR	$26.62 / g	$133.10	2015-07-03	Active
45802-0042-02 You're viewing this	1 APPLICATOR in 1 CARTON (45802-042-02) / 5 g in 1 APPLICATOR	—	—	2015-07-03	Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 45802-0042-02?

NDC 45802-0042-02 is listed by the FDA — 1 applicator in 1 carton / 5 g in 1 applicator.

What NDC number is used to bill for this package of Clindesse clindamycin phosphate 100 mg/5g Cream?

Bill NDC 45802-0042-02 — the 11-digit billing format is 45802004202. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 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	✓ 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	✓ 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 FDA registers it as 45802-042-02, 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: 45802-0042-02, written without dashes as 45802004202. 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 45802-0042-02, the first segment (45802) is the labeler code FDA assigned to Padagis Israel Pharmaceuticals Ltd; the middle segment (0042) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 Padagis Israel Pharmaceuticals 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 1 other package presentation of this same product, including 1 applicator (45802-0042-01). 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?

Padagis Israel Pharmaceuticals 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.

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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage 54 words ▾

1 INDICATIONS AND USAGE Clindesse is a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in non-pregnant women ( 1.1 )

1.1Treatment of Bacterial Vaginosis Clindesse is indicated for the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis) in non-pregnant women.

⏱️ Dosage and Administration 69 words ▾

2 DOSAGE AND ADMINISTRATION The recommended dose is the complete contents of a single pre-filled applicator containing 5 g of Clindesse cream administered once intravaginally at any time of the day. Not for ophthalmic, dermal, or oral use. • For intravaginal use only • A single applicator of cream administered once intravaginally at any time of the day ( 2 ) • Not for ophthalmic, dermal, or oral use

💊 Dosage Forms and Strengths 57 words ▾

3 DOSAGE FORMS AND STRENGTHS Clindesse is an intravaginal cream containing clindamycin phosphate 2%. Each pre-filled, single-dose applicator delivers approximately 5 g of cream containing approximately 100 mg of clindamycin. Vaginal cream: 2% clindamycin phosphate in one single-dose, pre-filled disposable applicator that delivers approximately 5 g of cream containing approximately 100 mg of clindamycin ( 3 )

⛔ Contraindications 96 words ▾

4 CONTRAINDICATIONS • History of hypersensitivity to clindamycin or other lincosamides ( 4.1 ) • History of regional enteritis, ulcerative colitis, or a history of Clostridioides difficile- associated diarrhea ( 4.2 , 5.1 )

4.1Hypersensitivity Clindesse is contraindicated in individuals with a history of hypersensitivity to clindamycin or other lincosamides. Reported reactions to other formulations of clindamycin include rashes, urticaria, erythema multiforme, and anaphylactoid reactions [see Adverse Reactions ( 6.2 )] .

4.2History of Bowel Disease Clindesse is contraindicated in patients with regional enteritis, ulcerative colitis, or a history of Clostridioides difficile -associated diarrhea.

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS • Clostridioides difficile -Associated Diarrhea: Discontinue and evaluate if diarrhea occurs ( 5.1 ) • Use with Condoms and Vaginal Contraceptive Diaphragms: The use of barrier contraceptives (condoms or vaginal contraceptive diaphragms) is not recommended concurrently or for 5 days following treatment. Condoms may not be reliable for preventing pregnancy or for protecting against transmission of HIV and other sexually transmitted diseases during this time period ( 5.2 , 8.3 )

5.1Clostridioides difficile -Associated Diarrhea (CDAD) Clostridioides difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD.

Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated [see Adverse Reactions ( 6.2 )] .

5.2Use with Condoms and Vaginal Contraceptive Diaphragms This cream contains mineral oil that may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms. Therefore, the use of such barrier contraceptives is not recommended concurrently or for 5 days following treatment with Clindesse. During this time period, condoms may not be reliable for preventing pregnancy or for protecting against transmission of HIV and other sexually transmitted diseases [see Use in Specific Populations ( 8.3 )] .

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Most common adverse reactions reported in ≥2% of patients and at a higher rate in the Clindesse group than in the placebo group are vaginosis fungal (14%), headache (7%), back pain (5%), constipation (2%), and urinary tract infection (2%) ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Padagis ® at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Study Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to Clindesse in 368 patients. Clindesse was studied in three clinical studies: placebo-controlled (n=85), active-controlled (n=263), and single-arm (n=20).

The population was female, aged 18 to 78, who were diagnosed with bacterial vaginosis. Patient demographics in the trials were 51% Caucasian, 36% Black, 10% Hispanic, and 3% Asian, other or unknown. All patients received 100 mg clindamycin phosphate cream intravaginally in a single dose.

Of the 368 women treated with a single dose of Clindesse, 1.6% of the patients discontinued therapy due to adverse reactions. Adverse reactions occurred in 126 of 368 patients (34%) treated with Clindesse and in 32 of 85 patients (38%) treated with placebo. Adverse reactions occurring in ≥2% of patients receiving Clindesse in the placebo-controlled clinical trial are shown in Table 1.

Table 1. Adverse Reactions Occurring in ≥2% of Clindesse-Treated Patients and at a Higher Rate than Placebo-Treated Patients Adverse Reactions Clindesse N=85 n (%) Placebo N=85 n (%) Vaginosis fungal NOS* 12 (14) 7 (8) Headache NOS 6 (7) 2 (2) Back Pain 4 (5) 1 (1) Constipation 2 (2) 0 (0) Urinary tract infection NOS 2 (2) 0 (0) N = number of patients in intent-to-treat population n (%) = number and percentage of patients with reported adverse reaction NOS = not otherwise specified *The use of clindamycin may result in the overgrowth of non-susceptible fungal organisms in the vagina and may require antifungal treatment Other reactions reported by <1% of those women treated with Clindesse include: Dermatologic: Pruritic rash Gastrointestinal: Diarrhea, vomiting General: Fatigue Immune System: Hypersensitivity Nervous System: Dizziness Reproductive System: Dysfunctional uterine bleeding, dysmennorrhea, intermenstrual bleeding, pelvic pain, vaginal burning, vaginal irritation, vulvar erythema, vulvitis, vulvovaginal discomfort, vulvovaginal dryness, vulvovaginitis

6.2Other Clindamycin Formulations Clindesse affords minimal peak serum levels and systemic exposure (AUCs) of clindamycin compared to an oral or intravenous dose of clindamycin [see Clinical Pharmacology ( 12.3 )] . Data from well-controlled trials directly comparing clindamycin administered orally to clindamycin administered vaginally are not available. The following additional adverse reactions and altered laboratory tests have been reported with the oral or parenteral use of clindamycin: Gastrointestinal: Abdominal pain, esophagitis, nausea, Clostridioides difficile -associated diarrhea [see Warnings and Precautions ( 5.1 )] .

Hematopoietic: Transient neutropenia (leukopenia), eosinophilia, agranulocytosis, and thrombocytopenia have been reported. No direct etiologic relationship to concurrent clindamycin therapy could be made in any of these reports. Hypersensitivity Reactions: Maculopapular rash, vesiculobullous rash, and urticaria have been observed during drug therapy.

Generalized mild to moderate morbilliform-like skin rashes are the most frequently reported of all adverse reactions. Cases of erythema multiforme, some resembling Stevens-Johnson syndrome, have been associated with clindamycin. A few cases of anaphylactoid reactions have been reported.

Liver: Jaundice and abnormalities in liver function tests have been observed duri…

🔄 Drug Interactions 65 words ▾

7 DRUG INTERACTIONS No formal drug interaction studies have been conducted for Clindesse. Neuromuscular blocking agents: Enhanced action of neuromuscular blocking agents can occur; use with caution ( 7.1 )

7.1Neuromuscular Blocking Agents Orally or intravenously administered clindamycin has neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Clindesse has not been studied in pregnant women. The systemic exposure (based on AUC and C max ) of Clindesse administered intravaginally is substantially lower than clindamycin administered intravenously [see Clinical Pharmacology ( 12.3 )] ; therefore, maternal use is not likely to result in significant fetal exposure to the drug. Available data from published observational studies and randomized controlled trials over decades of use with other clindamycin products during pregnancy have not identified an increased risk of major birth defects, miscarriage, or other adverse maternal and fetal outcomes.

In animal reproduction studies, no adverse developmental outcomes were observed in pregnant rats and mice administered oral doses of clindamycin at up to 600 mg/kg/day (58 and 29 times, respectively, the recommended human dose based on a body surface area comparison) ( see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Reproduction studies have been performed in rats and mice using oral doses of clindamycin up to 600 mg/kg/day (58 and 29 times, respectively, the recommended human dose based on body surface area comparisons) and have revealed no evidence of harm to the fetus due to clindamycin.

8.2Lactation Risk Summary The systemic exposure (based on AUC and C max ) of Clindesse is substantially lower than intravenous administration of clindamycin [see Clinical Pharmacology ( 12.3 )] ; therefore, adverse effects on the breastfed infant are not expected from transfer of clindamycin into breastmilk. There are no data on the effect of clindamycin on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Clindesse and any potential adverse effects on the breastfed infant from Clindesse or from the underlying maternal condition.

8.3Females and Males of Reproductive Potential Contraception Clindesse contains mineral oil that may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms. Therefore, the use of such barrier contraceptives is not recommended concurrently or for 5 days following treatment with Clindesse. During this time period, condoms may not be reliable for preventing pregnancy or for protecting against transmission of HIV and other sexually transmitted diseases [see Warnings and Precautions ( 5.2 )].

8.4Pediatric Use The safety and efficacy of Clindesse in the treatment of bacterial vaginosis in post-menarchal females have been established on the extrapolation of clinical trial data from adult women. The safety and efficacy of Clindesse in pre-menarchal females have not been established.

8.5Geriatric Use Clinical studies with Clindesse did not include sufficient numbers of subjects 65 years of age or older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Clindesse has not been studied in pregnant women. The systemic exposure (based on AUC and C max ) of Clindesse administered intravaginally is substantially lower than clindamycin administered intravenously [see Clinical Pharmacology ( 12.3 )] ; therefore, maternal use is not likely to result in significant fetal exposure to the drug. Available data from published observational studies and randomized controlled trials over decades of use with other clindamycin products during pregnancy have not identified an increased risk of major birth defects, miscarriage, or other adverse maternal and fetal outcomes.

In animal reproduction studies, no adverse developmental outcomes were observed in pregnant rats and mice administered oral doses of clindamycin at up to 600 mg/kg/day (58 and 29 times, respectively, the recommended human dose based on a body surface area comparison) ( see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Reproduction studies have been performed in rats and mice using oral doses of clindamycin up to 600 mg/kg/day (58 and 29 times, respectively, the recommended human dose based on body surface area comparisons) and have revealed no evidence of harm to the fetus due to clindamycin.

🧒 Pediatric Use 44 words ▾

8.4Pediatric Use The safety and efficacy of Clindesse in the treatment of bacterial vaginosis in post-menarchal females have been established on the extrapolation of clinical trial data from adult women. The safety and efficacy of Clindesse in pre-menarchal females have not been established.

🧓 Geriatric Use 45 words ▾

8.5Geriatric Use Clinical studies with Clindesse did not include sufficient numbers of subjects 65 years of age or older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

🆘 Overdosage 31 words ▾

10 OVERDOSAGE Vaginally applied clindamycin phosphate vaginal cream 2% could be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions (5.1) and Adverse Reactions ( 6.2 )] .

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Clindamycin is an antibacterial drug [see Clinical Pharmacology, Microbiology ( 12.4 )] .

12.3Pharmacokinetics Following a single intravaginal application of Clindesse cream to 20 healthy women, the mean (range) AUC 0-inf and C max estimates were 175 (38.6 to 541) ng/mL•hr and 6.6 (0.8 to 39) ng/mL, respectively. The mean C max of clindamycin for Clindesse was approximately 0.3%, 0.1%, and 7.6% of that observed after the administration of a 150 mg Cleocin oral capsule (2.5 mcg/mL), a 600 mg Cleocin intravenous injection (10.9 mcg/mL), and a single dose of 100 mg of Cleocin Vaginal Cream (86.5 ng/mL), respectively.

The peak serum concentration of clindamycin was attained approximately 20 hours post dosing for Clindesse.

12.4Microbiology Mechanism of Action Clindamycin inhibits bacterial protein synthesis at the level of the bacterial ribosome. The antibiotic binds preferentially to the 50S ribosomal subunit and affects the process of peptide chain initiation. Although clindamycin phosphate is inactive in vitro, in vivo hydrolysis converts this compound to the antibacterially active clindamycin.

Activity In Vitro Clindamycin is an antibacterial agent active in vitro against most strains of the following organisms that have been reported to be associated with bacterial vaginosis: Bacteroides spp. Gardnerella vaginalis Mobiluncus spp. Mycoplasma hominis Peptostreptococcus spp.

Standard methodology for the susceptibility testing of the potential bacterial vaginosis pathogens has not been defined. Culture and sensitivity testing of bacteria are not routinely performed to establish the diagnosis of bacterial vaginosis [see Clinical Studies ( 14 )] .

🧬 Mechanism of Action 17 words ▾

12.1Mechanism of Action Clindamycin is an antibacterial drug [see Clinical Pharmacology, Microbiology ( 12.4 )] .

📦 How Supplied / Storage and Handling 52 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Clindesse (clindamycin phosphate) Vaginal Cream, 2%, is available in cartons containing one single-dose, pre-filled disposable applicator (NDC 45802-042-01). Each applicator delivers approximately 5 g of vaginal cream containing approximately 100 mg of clindamycin. Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature.] Avoid heat above 30°C (86°F).

📋 Description 136 words ▾

11 DESCRIPTION Clindamycin phosphate, a lincosamide, is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is methyl 7-chloro- 6,7,8-trideoxy-6-(1-methyl- trans - 4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo-(alpha)-D-galacto- octopyranoside 2-(dihydrogen phosphate). It has a molecular weight of 504.96, and the molecular formula is C 18 H 34 CIN 2 O 8 PS.

The structural formula is represented below: Clindesse is a semi-solid, white cream, which contains clindamycin phosphate, USP, at a concentration equivalent to 20 mg clindamycin base per gram. The cream also contains edetate disodium, glycerol monoisostearate, lecithin, methylparaben, microcrystalline wax, mineral oil, polyglyceryl-3-oleate, propylparaben, purified water, silicon dioxide and sorbitol solution. Clindesse does not comply with the pH test of the USP monograph for clindamycin phosphate vaginal cream.

Structural Formula

💬 Information for Patients 215 words ▾

17 PATIENT COUNSELING INFORMATION Vaginal Intercourse and Use with Vaginal Products Instruct the patient not to engage in vaginal intercourse, or use other vaginal products (such as tampons or douches) during treatment with this product. Use with Condoms and Vaginal Contraceptive Diaphragms Advise the patient that Clindesse contains mineral oil that may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms. Therefore, do not use barrier contraceptives concurrently or for 5 days following treatment with Clindesse.

During this time period, condoms may not be reliable for preventing pregnancy or for protecting against transmission of HIV and other sexually transmitted diseases [see Warnings and Precautions ( 5.2 ) and Use in Specific Populations ( 8.3 )] . Fungal Vaginal Infections Inform the patient that vaginal fungal infections can occur following use of Clindesse and may require treatment with an antifungal drug [see Adverse Reactions ( 6.1 )] . Accidental Exposure to the Eye Inform the patient that Clindesse contains ingredients which cause burning and irritation of the eye.

In the event of accidental contact with the eye, rinse the eye with copious amounts of cool tap water and consult a physician. Manufactured by Padagis ® Yeruham, Israel Patents at www.padagis.com/patents Cleocin is a registered trademark of Pharmacia & Upjohn Company. 2S000 RC PH7

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

in vivo: In a living person or animal rather than in a laboratory dish.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

active-controlled: Describes a study that compares a new medicine against another medicine already known to work, instead of a dummy pill.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agranulocytosis: A severe drop in a certain type of infection-fighting white blood cell, greatly raising the risk of serious infections.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

Clostridioides difficile: A type of gut germ that can overgrow and cause severe, watery diarrhea, often after antibiotic use.

colitis: Swelling and irritation of the inner lining of the large intestine, or colon.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

contraception: Methods used to prevent pregnancy, such as birth control pills, condoms, or an intrauterine device.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

electrolyte: A mineral in the blood and body fluids, such as sodium, potassium, or calcium, that carries a small electric charge and helps the body work.

eosinophilia: A higher-than-normal level of eosinophils, a type of white blood cell often linked to allergies or drug reactions.

erythema: Redness of the skin caused by increased blood flow, often from irritation or inflammation.

erythema multiforme: A skin reaction with red, target-shaped spots, usually on the hands, arms, or face.

esophagitis: Swelling and irritation of the lining of the food pipe, or esophagus.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

jaundice: Yellowing of the skin and the whites of the eyes caused by too much bilirubin in the blood.

lactation: The making and release of milk from a mother's breasts after giving birth.

leukopenia: A low level of white blood cells, the cells that help the body fight off infections.

liver function tests: Blood tests that check how well the liver is working and whether it is irritated or damaged.

maculopapular rash: A common rash made up of flat red patches mixed with small raised bumps.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neutropenia: A low level of neutrophils, a type of white blood cell that fights infection, which can make it easier to catch infections.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

parenteral: Given by injection or drip into the body rather than swallowed by mouth.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

refractory: Describing a disease that does not respond to, or improve with, treatment.

reproductive potential: The ability to have children, meaning a person who could become pregnant or could father a child.

Stevens-Johnson syndrome: A rare, serious reaction causing painful blistering and peeling of the skin and the moist linings of the mouth, eyes, and other areas.

susceptibility testing: A lab test that grows germs from a sample and checks which medicines can stop or kill them.

thrombocytopenia: A low level of platelets, the blood cells that help form clots, which can lead to easier bruising or bleeding.

urticaria: Raised, itchy welts on the skin, commonly called hives.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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

🔗 Related NDC lookups

🧪 All Clindamycin Phosphate NDCsSame ingredient 🏭 All Padagis labeler NDCsLabeler code 45802 📚 All Lincosamide Antibacterial NDCsDrug class

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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.