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Tazarotene 1 mg/g Cream — NDC 51672-1374-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Tazarotene 1 mg/g Cream — NDC 51672-1374-2 (Billing 51672-1374-02)

by Sun Pharmaceutical Industries, Inc. · 1 TUBE in 1 CARTON / 30 g in 1 TUBE

This is a package of Tazarotene 1 mg/g Cream from Sun Pharmaceutical Industries, Inc., marketed since Apr 2017 and currently FDA-listed. It is this product's only package size.

NDC 51672-1374-02
🏷️ FDA NDC (as labeled) 51672-1374-2 billing pads the package segment with a zero
Rx only Generic 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 51672-1374-2
Product NDC 51672-1374
11-digit billing NDC 51672137402
RxCUI 313200
UNII 81BDR9Y8PS
Application # ANDA208258
SPL Set ID 34d79c31-1568-4797-a4f5-31200c7788db
Established class (EPC) Retinoid
Chemical class Retinoids
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-04-03
Route TOPICAL
Dosage form CREAM
Substance TAZAROTENE
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 313200
Why two NDCs? The FDA registers this code as 51672-1374-2 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 51672-1374-02. 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 Retinoid class.

Pharmacologic class Retinoid
Drug family (ATC) Other antipsoriatics for topical use
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

📖 What it is MedlinePlus · NLM

Tazarotene (Tazorac, Fabior) is used to treat acne. Tazarotene (Tazorac) is also used to treat psoriasis (a skin disease in which red, scaly patches form on some areas of the body). Tazarotene (Avage) is used to reduce facial wrinkling and discoloration in patients who are also using other skin care and sunlight avoidance programs. Tazarotene is in a class of medications called retinoids. It works to treat acne and psoriasis by slowing skin cell overgrowth and decreasing skin cell inflammation, which can lead to acne or psoriasis. It works to reduce facial wrinkles and discoloration by causing...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Tazarotene cream is designed to help reduce the look of fine facial wrinkles, blotchy skin discoloration (patches that are lighter or darker than normal), and flat pigmented spots...
  • What exactly does tazarotene cream do for my skin?
  • Take off any makeup first and make sure your skin is completely dry before you put it on. Then apply just a pea-sized amount — that's really all you need — and spread it lightly ov...
  • Yes, some burning, redness, peeling, and itching are very common when you first start using tazarotene — your skin is adjusting to a retinoid, and that takes time. Keeping up with...
📖 Read our full Tazarotene Topical guide →
1
Nutrient depletion considerations

Tazarotene may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Tazarotene 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 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 · Q2 2026 $3.37 $100.96 / 30 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
51672-1374-02 You're viewing this Main listing 1 TUBE in 1 CARTON / 30 g in 1 TUBE 2017-04-03 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tazarotene 1 mg/g 00713-0670-31 Cosette 1 tube $1.924 AB Availability likely —
Tazarotene 1 mg/g 51672-1373-02 Sun 1 tube $1.924 AB Availability likely —
Tazarotene 1 mg/g 68308-0745-30 Mayne 1 tube $1.924 AB Availability likely —
Tazarotene 1 mg/g 45802-0442-01 Padagis 1 tube $5.715 AB Availability likely —
Tazarotene 1 mg/g 00713-0804-31 Cosette 1 tube $6.504 AB Availability likely —
Tazarotene 1 mg/gthis 51672-1374-02 Sun 1 tube — AB FDA listed —
Tazarotene 1 mg/g 72162-2202-03 Bryant 1 tube — AB FDA listed —
Trilitas 1 mg/g 87143-0200-30 Perfero 1 tube — 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

🏛️
2017
On the market since
Apr 2017
📍
2026
Currently FDA-listed
9 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.

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 LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII 809Y72KV36
    A synthetic polymer made from acrylic acid and crosslinked with allyl pentaerythritol. It's used as a thickening agent and gelling ingredient in creams, gels, and lotions to create the proper texture and help the medicine spread and stay on the skin.
  • UNII HHT01ZNK31
    Carbomer Homopolymer Type B is a synthetic polymer made from acrylic acid. It absorbs water and forms a gel, so it's used in medicines as a thickener, suspending agent, and to help create a smooth texture in creams, gels, and lotions.
  • 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 C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • 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 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII HX1032V43M
    Sodium thiosulfate is a salt compound used in medicines as a buffer and pH regulator. It helps stabilize the medication and may also serve as a preservative or antioxidant to maintain product quality.
  • UNII 06XEA2VD56
    Sorbitan oleate is an emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in the medicine.
  • 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.

10 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

LabelerSun Pharmaceutical Industries, Inc.
Application holderSUN PHARMA CANADA INC
FDA applicationANDA208258 (ANDA)
Labeler code51672
First marketedApr 2017
Product typeHuman Prescription Drug
Portfolio889 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.

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 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 213 words ▾

1 INDICATIONS AND USAGE Tazarotene cream, 0.1% is indicated as an adjunctive agent for use in the mitigation (palliation) of facial fine wrinkling, facial mottled hyper-and hypopigmentation, and benign facial lentigines in patients who use comprehensive skin care and sunlight avoidance programs. Tazarotene cream, 0.1% is a retinoid indicated as an adjunctive agent for use in the mitigation (palliation) of facial fine wrinkling, facial mottled hyper- and hypopigmentation, and benign facial lentigines in patients who use comprehensive skin care and sunlight avoidance programs.

( 1 ) Limitations of Use: Does not eliminate or prevent wrinkles or restore more youthful skin. ( 1 ) Does not repair sun damaged skin or reverse photoaging. ( 1 ) Safety and effectiveness for the prevention or treatment of actinic keratoses, skin neoplasms, or lentigo maligna have not been established.

( 1 , 5.4 ) Limitations of Use: Tazarotene cream does not eliminate or prevent wrinkles or restore more youthful skin. Tazarotene cream does not reverse photoaging or repair sun damaged skin; tazarotene cream does not mitigate coarse or deep wrinkling, tactile roughness, telangiectasia, skin laxity, keratinocytic atypia, melanocytic atypia, or dermal elastosis. The safety and the effectiveness of tazarotene cream for the prevention or treatment of actinic keratoses, skin neoplasms, or lentigo maligna have not been established.

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION Apply a pea-sized amount of tazarotene cream to lightly cover the entire face once daily at bedtime. ( 2 ) If contact with eyes occurs, rinse thoroughly with water. ( 2 ) Not for ophthalmic, oral, or intravaginal use. ( 2 )

2.1Assessment Prior to Treatment Initiation Obtain a pregnancy test within 2 weeks prior to tazarotene cream therapy. Initiate tazarotene cream therapy during a menstrual period [see Contraindications (4) , Warnings and Precautions (5.1) , and Use in Specific Populations (8.1 , 8.3) ] . Carefully assess facial pigmented lesions of concern by a qualified physician (e.g., dermatologist) before application of tazarotene cream [see Warnings and Precautions (5.4) ] .

2.2Important Administration Instructions Avoid accidental transfer of tazarotene cream into eyes, mouth, or other mucous membranes. If contact with mucous membranes occurs, rinse thoroughly with water [see Warnings and Precautions (5.2) ] . Wash hands thoroughly after application.

Emollients or moisturizers can be applied either before or after applying tazarotene cream. However, ensure that the first cream or lotion has absorbed into the skin and has dried completely before subsequent cream or lotion application. Use facial moisturizers as frequently as desired [see Warnings and Precautions (5.2) ].

Tazarotene cream is for topical use only. Tazarotene cream is not for ophthalmic, oral, or intravaginal use. Use effective sunscreens and wear protective clothing while using tazarotene cream [see Warnings and Precautions (5.3) ].

2.3Dosage and Administration Instructions Remove any makeup before applying tazarotene cream to the face. Dry the skin before applying the cream after face washing, bathing, or showering. Apply a pea-sized amount once a day at bedtime to lightly cover the entire face, including the eyelids, if desired. Wash hands thoroughly after application.

💊 Dosage Forms and Strengths 25 words ▾

3 DOSAGE FORMS AND STRENGTHS Cream: 1 mg of tazarotene per gram (0.1%) of white cream in 30 gram tubes. Cream, 0.1%. ( 3 )

⛔ Contraindications 61 words ▾

4 CONTRAINDICATIONS Tazarotene cream is contraindicated in: Pregnancy. Retinoids may cause fetal harm when administered to a pregnant female [see Warnings and Precautions (5.1) , Use in Specific Populations (8.1 , 8.3) ] . Individuals who have known hypersensitivity to any of its components. [see Warnings and Precautions (5.2) ]. Pregnancy. ( 4 , 8.1 ) Known Hypersensitivity. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Embryo-Fetal Toxicity: May cause fetal harm when administered to a pregnant woman. Obtain a pregnancy test in females of reproductive potential within 2 weeks prior to initiating treatment. Advise females of reproductive potential to use effective contraception.

( 5.1 ) Local Irritation: Some individuals may experience excessive pruritus, burning, skin redness, or peeling. If these adverse reactions occur, discontinue tazarotene cream until the integrity of the skin has been restored or reduce dosing interval. Avoid using tazarotene cream on eczematous skin, as such use may cause severe irritation.

( 5.2 ) Photosensitivity and Risk of Sunburn: Avoid exposure to sunlight, sunlamps, and weather extremes. Wear sunscreen daily. Avoid using tazarotene cream if the patient is also taking drugs known to be photosensitizers.

( 5.3 ) Lentigo Maligna: Carefully assess facial pigmented lesions of concern before application of tazarotene cream. ( 5.4 )

5.1Embryofetal Toxicity Based on data from animal reproduction studies, retinoid pharmacology and the potential for systemic absorption, tazarotene cream may cause fetal harm when administered to a pregnant female and is contraindicated during pregnancy . Safety in pregnant females has not been established. The potential risk to the fetus outweighs the potential benefit to the mother from tazarotene cream use during pregnancy; therefore, discontinue tazarotene cream as soon as pregnancy is recognized.

Tazarotene elicits malformations and developmental effects associated with retinoids after topical and oral administration to pregnant rats and rabbits during organogenesis. However, limited case reports of pregnancy in females enrolled in clinical trials for tazarotene cream have not reported a clear association with tazarotene and major birth defects or miscarriage risk [see Contraindications (4) , Use in Specific Populations (8.1) ] . Systemic exposure to tazarotenic acid is dependent upon the extent of the body surface area treated.

In patients treated topically over sufficient body surface area, exposure could be in the same order of magnitude as in these orally treated animals. Although there may be less systemic exposure in the treatment of the face alone due to less surface area for application, tazarotene is a teratogenic substance in animals, and it is not known what level of exposure is required for teratogenicity in humans [see Clinical Pharmacology (12.3) ]. Advise pregnant females of the potential risk to a fetus.

Obtain a pregnancy test within 2 weeks prior to tazarotene cream therapy. Initiate tazarotene cream therapy during a menstrual period. Advise females of reproductive potential to use effective contraception during treatment with tazarotene cream [see Dosage and Administration (2) , Use in Specific Populations (8.3) ] .

5.2Local Irritation and Hypersensitivity Reactions Local tolerability reactions (including blistering and skin desquamation) and hypersensitivity adverse reactions (including urticaria) have been observed with topical tazarotene. Application of tazarotene cream may cause excessive irritation in the skin of certain sensitive individuals. Some individuals may experience excessive pruritus, burning, skin redness, or peeling.

If these adverse reactions occur, discontinue the medication until the integrity of the skin is restored, or reduce the dosing to an interval the patient can tolerate. Closely monitor the frequency of application by carefully observing the therapeutic response and skin tolerance. Avoid concomitant use of topical medications and cosmetics that have a strong drying effect.

It is also advisable to "rest" a patient's skin until the effects of such preparations subside before use of tazarotene cream is begun. Avoid using tazarotene cream on eczematous skin because such use may cause severe irritation. Weather extremes, such as wind or cold, may be more irritating to patients using tazarotene cream.

5.3 Photosensit…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in more detail in other sections of the labeling: Embryofetal toxicity [see Warnings and Precautions (5.1) ] Photosensitivity and Risk of Sunburn [see Warnings and Precautions (5.3) ] Most common adverse events (occurring in ≥10% of patients) are desquamation, erythema, burning sensation, dry skin, skin irritation, and pruritus. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Taro Pharmaceuticals U.S.A., Inc. at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials 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 clinical practice. The most frequent adverse reactions reported with tazarotene cream, 0.1% that occurred in greater than 10% of subjects, included desquamation, erythema, burning sensation, and dry skin (in descending order). Reactions that occurred in 1 to 10% of subjects, included skin irritation, pruritus, irritant contact dermatitis, stinging, rash, and cheilitis (in descending order).

Common adverse events that occurred at a rate of at least 1% and at a higher rate in the tazarotene cream group than in the vehicle group in the clinical trials are presented in the following table. TABLE OF ADVERSE EVENTS SEEN IN 24-WEEK CLINICAL TRIALS WITH TAZAROTENE CREAM 0.1% Adverse Event Tazarotene Cream, 0.1% N=567 Vehicle N=564 Desquamation 40% 3% Erythema 34% 3% Burning Sensation 26% <1% Dry Skin 16% 3% Irritation Skin 10% 1% Pruritus 10% 1% Irritant Contact Dermatitis 8% 1% Stinging 3% <1% Rash 3% 1% Cheilitis 1% 0% A few subjects reported adverse events at Week 0; however, for patients who were treated with tazarotene cream, the highest number of new reports for each adverse event was at Week 2.

When combining data from the two trials, 5.3% of subjects in the tazarotene cream group and 0.9% of subjects in the vehicle group discontinued because of adverse events. Overall, 20/567 (3.5%) subjects in the tazarotene cream group and 16/564 (2.8%) subjects in the vehicle group reported adverse events (including edema, irritation, and inflammation) directly related to the eye or eyelid. The majority of these conditions were mild.

6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of tazarotene. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Skin and subcutaneous tissue disorders: blister, dermatitis, urticaria, skin exfoliation, skin discoloration (including skin hyperpigmentation or skin hypopigmentation), swelling at or near application sites, and pain.

🔄 Drug Interactions 106 words ▾

7 DRUG INTERACTIONS No formal drug-drug interaction studies were conducted with tazarotene cream. In a trial of 27 healthy female subjects between the ages of 20 to 55 years receiving a combination oral contraceptive tablet containing 1 mg norethindrone and 35 mcg ethinyl estradiol, concomitant use of tazarotene administered as 1.1 mg orally (mean ± SD C max and AUC 0-24 of tazarotenic acid were 28.9 ± 9.4 ng/mL and 120.6 ± 28.5 ng*h/mL) did not affect the pharmacokinetics of norethindrone and ethinyl estradiol over a complete cycle.

The impact of tazarotene on the pharmacokinetics of progestin only oral contraceptives (i.e., minipills) has not been evaluated.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Based on data from animal reproduction studies, retinoid pharmacology, and the potential for systemic absorption, tazarotene cream may cause fetal harm when administered to a pregnant female and is contraindicated during pregnancy. Safety in pregnant females has not been established. The potential risk to the fetus outweighs the potential benefit to the mother from tazarotene cream during pregnancy; therefore, tazarotene cream should be discontinued as soon as pregnancy is recognized [see Contraindications (4) , Warnings and Precautions (5.1) , Clinical Pharmacology (12.3) ].

Limited case reports of pregnancy in females enrolled in clinical trials for tazarotene cream have not established a clear association with tazarotene and major birth defects or miscarriage risk. Because the exact timing and extent of exposure in relation to the gestational age are not certain, the significance of these findings is unknown . In animal reproduction studies with pregnant rats, tazarotene dosed topically during organogenesis at 2 times the maximum systemic exposure in subjects treated with the maximum recommended human dose (MRHD) of tazarotene cream, 0.1% resulted in reduced fetal body weights and reduced skeletal ossification.

In animal reproduction studies with pregnant rabbits dosed topically with tazarotene gel at 26 times the maximum systemic exposure in subjects treated with the MRHD of tazarotene cream, 0.1%, there was a single incident of known retinoid malformations, including spina bifida, hydrocephaly, and heart anomalies. In animal reproduction studies with pregnant rats and rabbits, tazarotene dosed orally during organogenesis at 2 and 52 times, respectively, the maximum systemic exposure in subjects treated with the MRHD of tazarotene cream, 0.1% resulted in malformations, fetal toxicity, developmental delays, and/or behavioral delays .

In pregnant rats, tazarotene dosed orally prior to mating through early gestation resulted in decreased litter size, decreased numbers of live fetuses, decreased fetal body weights, and increased malformations at doses approximately 7 times higher than the maximum systemic exposure in subjects treated with the MRHD of tazarotene cream, 0.1% [see Data ]. The background risk of major birth defects and miscarriage for the indicated population is unknown. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications.

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 In rats, a tazarotene 0.05% gel formulation dosed topically during gestation days 6 through 17 at 0.25 mg/kg/day, which represented 2 times the maximum systemic exposure in subjects treated with the MRHD of tazarotene cream, 0.1% ( i.e. , 2 mg/cm 2 over a 15% body surface area), resulted in reduced fetal body weights and reduced skeletal ossification.

Rabbits dosed topically with 0.25 mg/kg/day tazarotene gel, which represented 26 times the maximum systemic exposure in subjects treated with the MRHD of tazarotene cream, 0.1%, during gestation days 6 through 18, had a single incident of known retinoid malformations, including spina bifida, hydrocephaly, and heart anomalies. When tazarotene was given orally to animals, developmental delays were seen in rats, and malformations and post-implantation loss were observed in rats and rabbits at doses representing 2 and 52 times, respectively, the maximum systemic exposure seen in subjects treated with the MRHD of tazarotene cream, 0.1%.

In female rats orally administered 2 mg/kg/day of tazarotene from 15 days before mating through gestation day 7, which represented 7 times the maximum systemic exposure in subjects treated with the MRHD of tazarotene cream, 0.1%, classic developmental effects of retinoids were observed including decreased number of implantati…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Based on data from animal reproduction studies, retinoid pharmacology, and the potential for systemic absorption, tazarotene cream may cause fetal harm when administered to a pregnant female and is contraindicated during pregnancy. Safety in pregnant females has not been established. The potential risk to the fetus outweighs the potential benefit to the mother from tazarotene cream during pregnancy; therefore, tazarotene cream should be discontinued as soon as pregnancy is recognized [see Contraindications (4) , Warnings and Precautions (5.1) , Clinical Pharmacology (12.3) ].

Limited case reports of pregnancy in females enrolled in clinical trials for tazarotene cream have not established a clear association with tazarotene and major birth defects or miscarriage risk. Because the exact timing and extent of exposure in relation to the gestational age are not certain, the significance of these findings is unknown . In animal reproduction studies with pregnant rats, tazarotene dosed topically during organogenesis at 2 times the maximum systemic exposure in subjects treated with the maximum recommended human dose (MRHD) of tazarotene cream, 0.1% resulted in reduced fetal body weights and reduced skeletal ossification.

In animal reproduction studies with pregnant rabbits dosed topically with tazarotene gel at 26 times the maximum systemic exposure in subjects treated with the MRHD of tazarotene cream, 0.1%, there was a single incident of known retinoid malformations, including spina bifida, hydrocephaly, and heart anomalies. In animal reproduction studies with pregnant rats and rabbits, tazarotene dosed orally during organogenesis at 2 and 52 times, respectively, the maximum systemic exposure in subjects treated with the MRHD of tazarotene cream, 0.1% resulted in malformations, fetal toxicity, developmental delays, and/or behavioral delays .

In pregnant rats, tazarotene dosed orally prior to mating through early gestation resulted in decreased litter size, decreased numbers of live fetuses, decreased fetal body weights, and increased malformations at doses approximately 7 times higher than the maximum systemic exposure in subjects treated with the MRHD of tazarotene cream, 0.1% [see Data ]. The background risk of major birth defects and miscarriage for the indicated population is unknown. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications.

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 In rats, a tazarotene 0.05% gel formulation dosed topically during gestation days 6 through 17 at 0.25 mg/kg/day, which represented 2 times the maximum systemic exposure in subjects treated with the MRHD of tazarotene cream, 0.1% ( i.e. , 2 mg/cm 2 over a 15% body surface area), resulted in reduced fetal body weights and reduced skeletal ossification.

Rabbits dosed topically with 0.25 mg/kg/day tazarotene gel, which represented 26 times the maximum systemic exposure in subjects treated with the MRHD of tazarotene cream, 0.1%, during gestation days 6 through 18, had a single incident of known retinoid malformations, including spina bifida, hydrocephaly, and heart anomalies. When tazarotene was given orally to animals, developmental delays were seen in rats, and malformations and post-implantation loss were observed in rats and rabbits at doses representing 2 and 52 times, respectively, the maximum systemic exposure seen in subjects treated with the MRHD of tazarotene cream, 0.1%.

In female rats orally administered 2 mg/kg/day of tazarotene from 15 days before mating through gestation day 7, which represented 7 times the maximum systemic exposure in subjects treated with the MRHD of tazarotene cream, 0.1%, classic developmental effects of retinoids were observed including decreased number of implantation sites, decreased litter siz…

🧒 Pediatric Use 35 words ▾

8.4Pediatric Use The safety and efficacy of tazarotene cream have not been established in patients under the age of 17 years with facial fine wrinkling, facial mottled hyper- and hypopigmentation, and benign facial lentigines.

🧓 Geriatric Use 83 words ▾

8.5Geriatric Use In the studies of facial fine wrinkling, facial mottled hyper- and hypopigmentation, and benign facial lentigines, 44 male subjects and 180 female subjects out of the total population of 1131 subjects were older than 65 years of age. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other clinical experience has not identified differences in responses between the elderly and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.

🆘 Overdosage 51 words ▾

10 OVERDOSAGE Tazarotene cream is not for oral use. Oral ingestion of the drug may lead to the same adverse effects as those associated with excessive oral intake of Vitamin A (hypervitaminosis A) or other retinoids. If oral ingestion occurs, monitor the patient closely and administer appropriate supportive measures, as necessary.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Tazarotene is a retinoid prodrug which is converted to its active form, the carboxylic acid of tazarotene, by deesterification. Tazarotenic acid binds to all three members of the retinoic acid receptor (RAR) family: RARα, RARβ, and RARγ, but shows relative selectivity for RARβ and RARγ, and may modify gene expression. The clinical significance of these findings for the mitigation of facial fine wrinkling, facial mottled hyper- and hypopigmentation, and benign facial lentigines is unknown.

12.3Pharmacokinetics Following topical application, tazarotene undergoes esterase hydrolysis to form its active metabolite, tazarotenic acid. Little parent compound could be detected in the plasma. Tazarotenic acid was highly bound to plasma proteins (greater than 99%).

Tazarotene and tazarotenic acid were metabolized to sulfoxides, sulfones, and other polar metabolites which were eliminated through urinary and fecal pathways. The half-life of tazarotenic acid was approximately 18 hours. Tazarotene cream 0.1% was topically applied once daily over four weeks to either the face (6 females and 2 males) or to 15% of body surface area (8 females and 8 males) in subjects with fine wrinkling and mottled hyperpigmentation.

In the "face-only" dosing group, the maximum average C max and AUC 0-24hr values of tazarotenic acid occurred on Day 15 with mean ± SD values of C max and AUC 0-24hr of tazarotenic acid being 0.236 ± 0.255 ng/mL (N=8) and 2.44 ± 1.38 ng∙hr/mL (N=8), respectively. The mean C max and AUC 0-24hr values of tazarotenic acid from subjects in the 15% body surface area dosing group were approximately 10 times higher than those from subjects in the face-only dosing group. The single highest C max throughout the trial period was 3.43 ng/mL on day 29 from subjects in the 15% body surface area dosing group.

Gender had no influence on the systemic bioavailability of tazarotenic acid. Blood samples were collected from one of the two phase 3 trials to evaluate the systemic exposure following application of tazarotene cream 0.1% once daily for 24 weeks (double-blind period) followed by 28 weeks (open-label) under clinical conditions. The mean plasma tazarotenic acid concentrations, following topical treatment with tazarotene cream 0.1% over 52 weeks, ranged between 0.092 ± 0.073 ng/mL and 0.127 ± 0.142 ng/mL.

The single highest observed tazarotenic acid concentration throughout the 52-week trial was 0.705 ng/mL (observed at week 36). Systemic availability of tazarotenic acid was minimal and remained steady following once daily application of tazarotene cream 0.1% to the faces of subjects in the trial for up to 52 weeks.

🧬 Mechanism of Action 78 words ▾

12.1Mechanism of Action Tazarotene is a retinoid prodrug which is converted to its active form, the carboxylic acid of tazarotene, by deesterification. Tazarotenic acid binds to all three members of the retinoic acid receptor (RAR) family: RARα, RARβ, and RARγ, but shows relative selectivity for RARβ and RARγ, and may modify gene expression. The clinical significance of these findings for the mitigation of facial fine wrinkling, facial mottled hyper- and hypopigmentation, and benign facial lentigines is unknown.

📦 How Supplied / Storage and Handling 57 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Tazarotene cream 0.1%, containing 1 mg of tazarotene per gram of white cream is available in a 30 gram collapsible aluminum tube with a tamper-evident aluminum membrane over the opening and a white polypropylene screw cap. NDC 51672-1374-2 Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

📦 Storage and Handling 14 words ▾

Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

📋 Description 107 words ▾

11 DESCRIPTION Tazarotene cream, 0.1% is for topical use and contains the active ingredient, tazarotene. Each gram of tazarotene cream, 0.1% contains 1 mg of tazarotene in a white cream base. Tazarotene is a member of the acetylenic class of retinoids.

Chemically, tazarotene is ethyl 6-[2-(4,4-dimethylthiochroman-6-yl)ethynyl] nicotinate. The compound has an empirical formula of C 21 H 21 NO 2 S and molecular weight of 351.46. The structural formula is shown below: Tazarotene Cream contains the following inactive ingredients: carbomer copolymer type B, carbomer homopolymer type B, edetate disodium, medium-chain triglycerides, mineral oil, purified water, sodium hydroxide (to adjust pH), sodium thiosulfate, and sorbitan monooleate.

Chemical Structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Embryofetal Toxicity Inform females of reproductive potential of the potential risk to a fetus. Advise these patients to use effective contraception during treatment with tazarotene cream.

Advise patients to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1 , 8.3) ]. Photosensitivity and Risk of Sunburn Advise patients to avoid excessive sun exposure and to use of sunscreens and protective measures (hat, visor). Advise patients to avoid using tazarotene if also taking other medicines may increase sensitivity to sunlight.

Important Administration Instructions Advise patients of the following: Use tazarotene cream on the face once per day, at bedtime. Tazarotene cream is for topical use only. Do not apply to eyes, mouth, or other mucous membranes.

The cream may cause severe redness, itching, burning, stinging, and peeling. Avoid accidental transfer of tazarotene cream into eyes, mouth, or other mucous membranes. If contact with mucous membranes occurs, rinse thoroughly with water.

Seek medical attention if eye irritation continues. Wash hands thoroughly after applying tazarotene cream. Gently wash face with a mild soap before applying the cream.

Dry skin before applying the cream. Apply only a small pea sized amount (about ¼ inch or 5 millimeter diameter) to lightly cover the entire face. Apply emollients or moisturizers before or after tazarotene cream and ensure that the first cream or lotion has absorbed into the skin and dried completely.

In the morning, apply a moisturizing sunscreen.

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 Tazarotene — the program that covers self-administered drugs. 6 manufacturers.
⚠️ 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 Tazarotene. 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
$865K
Claims incl. refills
4.1K
Beneficiaries
3.1K
Spend / beneficiary
$279.29
Spend / claim
$209.69
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.

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 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 Sun Pharmaceutical Industries, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Sun Pharmaceutical Industries, 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.
← 51672-1373-02 · Sun 51672-1376-03 · Sun →
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.