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Clindamycin Phosphate and Benzoyl Peroxide 10 mg/g; 37.5 mg/g Gel, 50 g — NDC 45802-383-01 (Billing 45802-0383-01)

by Padagis Israel Pharmaceuticals Ltd · 50 g in 1 BOTTLE, PUMP

This is a package of 50 g of Clindamycin Phosphate and Benzoyl Peroxide 10 mg/g; 37.5 mg/g Gel from Padagis Israel Pharmaceuticals Ltd, marketed since Sep 2024 and currently FDA-listed; retail pharmacies pay about $2.34 per g (NADAC). It is this product's only package size.

NDC 45802-0383-01
🏷️ FDA NDC (as labeled) 45802-383-01 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 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 45802-383-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
45802 labeler · 383 product · 01 package
Package marketed since
Sep 20, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
50 g per package
Barcode (UPC-A, from the NDC)
3 4580238301 3
Medicaid fills, this package
5,595 prescriptions in the last four reported quarters
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 45802-383-01
Product NDC 45802-383
11-digit billing NDC 45802038301
NCPDP billing unit GM — per gram (weight)
Application # ANDA209610
SPL Set ID 16975cda-dd2a-4b2a-add9-6fb48af5b039
Established class (EPC) Lincosamide Antibacterial
Physiologic effect Decreased Sebaceous Gland Activity; Neuromuscular Blockade
Chemical class Lincosamides
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-09-20
Route TOPICAL
Dosage form GEL
Substance CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE
TE code (Orange Book) AB · RLD · RS

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

GCN Seq No 073195
GCN 37564
HICL code 017263
Ingredient (HICL) Clindamycin Phos/Benzoyl Perox
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L5
Therapeutic class — intermediate (HIC2) Keratolytics/Keratoplastics
HIC3 code L5H
Therapeutic class — specific (HIC3) Acne Agents,Topical
AHFS code 08:12.28.20
AHFS class Lincomycin Antibiotics
FDB label name CLINDAMYC-BNZ PEROX 1.2-3.75%
FDB brand name Clindamycin-Benzoyl Peroxide
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 073195
  • GCN: 37564
  • HICL (First Databank): 017263
  • AHFS class code: 08:12.28.20
Why two NDCs? The FDA registers this code as 45802-383-01 — 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 → 45802-0383-01. 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.

Clinical

Label name CLINDAMYC-BNZ PEROX 1.2-3.75% Ingredient Clindamycin Phos/Benzoyl Perox
📖 What it is MedlinePlus · NLM

The combination of clindamycin and benzoyl peroxide is used to treat acne. Clindamycin and benzoyl peroxide are in a class of medications called topical antibiotics. The combination of clindamycin and benzoyl peroxide works by killing the bacteria that cause acne.

Read the full MedlinePlus article ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 gPer package
Retail pharmacies payNADAC · weekly $2.344 $117.20 / 50 g
Medicaid paysCMS SDUD · 12 mo $4.45 $222.60 / 50 g
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per g) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $4.609 $2.344
▼ Down 48% over the last 10 months.
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
45802-0383-01 You're viewing this Main listing 50 g in 1 BOTTLE, PUMP 2024-09-20 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Clindamycin Phosphate and Benzoyl Peroxide 10 mg/g; 37.5 mg/gthis 45802-0383-01 Padagis 50 g $2.344 AB Availability likely —
Clindamycin Phosphate and Benzoyl Peroxide 10 mg/g; 50 mg/g 51672-1403-04 Sun 50 g $2.344 AB Availability likely —
Clindamycin Phosphate and Benzoyl Peroxide 10 mg/g; 37.5 mg/g 68308-0127-50 Mayne 50 g $2.344 AB Availability likely —
Clindamycin Phosphate and Benzoyl Peroxide 10 mg/g; 37.5 mg/g 68682-0133-50 Oceanside 1 bottle $6.070 AB FDA listed +159%
Onexton 10 mg/g; 37.5 mg/g 00187-3050-35 Bausch 3.5 g — AB FDA listed —
Clindamycin Phosphate and Benzoyl Peroxide 10 mg/g; 37.5 mg/g 72162-2419-02 Bryant 50 g — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2024
On the market since
Sep 2024
📍
2026
Currently FDA-listed
2 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerPadagis Israel Pharmaceuticals Ltd
Application holderPADAGIS ISRAEL PHARMACEUTICALS LTD
FDA applicationANDA209610 (ANDA)
Labeler code45802
First marketedSep 2024
Product typeHuman Prescription Drug
Portfolio175 products on file

More NDCs from Padagis Israel Pharmaceuticals Ltd labeler code 45802

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.
📄 FDA label
📄 FDA label 19 words ▾

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

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
5.6K
Units reimbursed last 4 qtrs
304.5K
Gross reimbursed last 4 qtrs
$1.36M
Avg / prescription
$242.26
Avg / unit
$4.4520
Latest quarter Q4 2025
1.9KRx
Medicaid pays / g
$4.4520
gross reimbursed
vs
NADAC / g
$2.3440
acquisition cost
=
Spread
+$2.1080
+90% vs cost
What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
91% FFS
Fee-for-service · 5,089 Rx Managed care · 506 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 191,730 units · 980 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: 550 units · 8.0 per 100k residents IN Ohio: no data reported OH Pennsylvania: 600 units · 4.6 per 100k residents PA New Jersey: 15,150 units · 163 per 100k residents NJ Massachusetts: no data reported MA California: 84,130 units · 216 per 100k residents CA Utah: no data reported UT Colorado: 1,500 units · 25.5 per 100k residents CO Nebraska: no data reported NE Missouri: 550 units · 8.9 per 100k residents MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 2,750 units · 31.6 per 100k residents VA Maryland: 2,150 units · 34.8 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 1,250 units · 17.5 per 100k residents TN North Carolina: 2,900 units · 26.8 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 600 units · 2.0 per 100k residents TX Florida: 600 units · 2.7 per 100k residents FL
Units reimbursed · per 100k residents
2.0980
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 980 /100k
2 California 216 /100k
3 New Jersey 163 /100k
4 Maryland 34.8 /100k
5 Virginia 31.6 /100k
6 North Carolina 26.8 /100k
7 Colorado 25.5 /100k
8 Tennessee 17.5 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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 Clindamycin Phosphate and Benzoyl Peroxide — the ingredient across all brands.

Top reported reactions

Erythema26
Acne25
Pruritus25
Rash22
Dry Skin18
Expired Product Administered16
Skin Discolouration13

Age at onset

Child1
Adolescent4
Adult23

Reporter sex

315 reports
Male · 20%
Female · 80%

Serious outcomes

Hospitalization19
Disabling3
Death3
Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 22 1
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.
← 45802-0376-32 · Padagis 45802-0390-00 · Padagis →
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.