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Metronidazole Topical Cream 7.5 mg/g Cream, 45 g

by DirectRx · 45 g in 1 TUBE (72189-306-45)
NDC 72189-0306-45
🏷️ FDA NDC (as labeled) 72189-306-45 billing pads the product segment with a zero
Rx only Brand Discontinued Non-controlled ⚠ Inactivated by FDA
🗂️ Data synced Jul 17, 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

⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2024. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 72189-306-45
Product NDC 72189-306
11-digit billing NDC 72189030645
NCPDP billing unit GM — per gram (weight)
Application # NDA020531
SPL Set ID d39922f0-c37c-fec3-e053-2995a90a141c
Chemical class Nitroimidazole Antimicrobial [EPC], Nitroimidazoles
DEA schedule Non-controlled
Marketing category NDA AUTHORIZED GENERIC
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2024)
Route TOPICAL
Dosage form CREAM
Substance METRONIDAZOLE
GCN Seq No 041799
GCN 43203
HICL code 004157
Ingredient (HICL) Metronidazole
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L5
Therapeutic class — intermediate (HIC2) Keratolytics/Keratoplastics
HIC3 code L5G
Therapeutic class — specific (HIC3) Rosacea Agents, Topical
AHFS code 08:30.04.00
AHFS class Amebicides
FDB label name METRONIDAZOLE 0.75% CREAM
FDB brand name Metronidazole
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 72189-306-45 — 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 → 72189-0306-45. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerDirectRx
Application holderGALDERMA LABORATORIES LP
FDA applicationNDA020531 (NDA AUTHORIZED GENERIC)
Labeler code72189
Product typeHuman Prescription Drug
Portfolio49 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name METRONIDAZOLE 0.75% CREAM Ingredient Metronidazole
📗 Our plain-language guide HelloPharmacist
  • This is one of the most important things to know about metronidazole. If you drink alcohol — or consume products containing propylene glycol — while taking it, you can have a prett...
  • Why do I have to avoid alcohol while taking this?
  • Yes, completely normal and actually really important. Trichomoniasis is a sexually transmitted infection, so even if your partner has no symptoms, they can still carry the parasite...
  • My partner and I both have to take this for trichomoniasis — is that normal?
📖 Read our full Metronidazole guide →

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.

🧪 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.

💲 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 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.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Metronidazole 7.5 mg/g 00168-0323-46 Fougera 45 g $0.268 AB Availability likely —
Metronidazole 7.5 mg/g 00713-0633-37 Cosette 1 tube $0.268 AB Availability likely —
Metronidazole 7.5 mg/g 59651-0770-46 Aurobindo 1 tube $0.268 AB Availability likely —
Metronidazole 7.5 mg/g 66993-0960-45 Prasco 1 tube $0.268 AB Availability likely —
Metronidazole 7.5 mg/g 68308-0711-45 Mayne 1 tube $0.268 AB Availability likely —
Metronidazole 7.5 mg/g 72578-0129-08 Viona 1 tube $0.268 BX Availability likely —
Metronidazole 7.5 mg/g 68788-8552-04 Preferred 1 tube — BX FDA listed —
Metronidazole 7.5 mg/g 70771-1834-04 Zydus 1 tube — BX FDA listed —
Metronidazole 7.5 mg/g 72162-2259-02 Bryant 45 g — AB FDA listed —
Metronidazole Topical Cream 7.5 mg/gthis 72189-0306-45 DirectRx 45 g — AB Discontinued —
About this product: this is an authorized generic — the brand-name product marketed without its brand name. 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

📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
72189-0306-45 You're viewing this 45 g in 1 TUBE (72189-306-45) 2022-01-18 Inactivated by FDA

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ 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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 72189-306-45, 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: 72189-0306-45, written without dashes as 72189030645. 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 72189-0306-45, the first segment (72189) is the labeler code FDA assigned to DirectRx; the middle segment (0306) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (45) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
DirectRx is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 18 words ▾

Metronidazole Topical Cream is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.

⏱️ Dosage and Administration 45 words ▾

Apply and rub in a thin layer of Metronidazole Topical Cream twice daily, morning and evening, to entire affected areas after washing. Areas to be treated should be washed with a mild cleanser before application. Patients may use cosmetics after application of Metronidazole Topical Cream.

⛔ Contraindications 20 words ▾

Metronidazole Topical Cream is contraindicated in individuals with a history of hypersensitivity to metronidazole, or other ingredients of the formulation.

🤒 Adverse Reactions 78 words ▾

In controlled clinical trials, the total incidence of adverse reactions associated with the use of Metronidazole Topical Cream was approximately 10%. Skin discomfort (burning and stinging) was the most frequently reported event followed by erythema, skin irritation, pruritus and worsening of rosacea. All individual events occurred in less than 3% of patients.

The following additional adverse experiences have been reported with the topical use of metronidazole: dryness, transient redness, metallic taste, tingling or numbness of extremities and nausea.

🧬 Clinical Pharmacology 20 words ▾

The mechanisms by which metronidazole acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect.

📦 How Supplied / Storage and Handling 50 words ▾

Metronidazole Topical Cream, 0.75% is supplied in a 45 g aluminum tube - Storage conditions: STORE AT CONTROLLED ROOM TEMPERATURE, 68° TO 77°F (20° TO 25°C), EXCURSIONS PERMITTED BETWEEN 59° TO 86°F (15° TO 30°C). Marketed by: Prasco Laboratories Mason, OH 45040 USA Made in Canada P53365-0 Issued: March 2017

📋 Description 85 words ▾

Metronidazole Topical Cream contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in an emollient cream consisting of benzyl alcohol, emulsifying wax, glycerin, isopropyl palmitate, purified water, sorbitol solution, lactic acid and/or sodium hydroxide to adjust pH. Metronidazole is a member of the imidazole class of antibacterial agents and is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is 2-methyl-5-nitro-1H- imidazole-1-ethanol.

The molecular formula is C6H9N3O3 and molecular weight is 171.16. Metronidazole is represented by the following structural formula: [metro-crm-chem-struct]

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 72189-0304-06 · DirectRx 72189-0307-30 · Directrx →
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.