HomeNDC LookupIngredientsBetamethasone Dipropionate › 16714-0996-02
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Betamethasone dipropionate .5 mg/g Cream

by Northstar Rx LLC. · 1 TUBE in 1 CARTON (16714-996-02) / 45 g in 1 TUBE
NDC 16714-0996-02
🏷️ FDA NDC (as labeled) 16714-996-02 billing pads the product segment with a zero
This package
Contains45 g in 1 tube Cost per g$0.3752 NADAC Per package$16.88 / 45 g Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.6209/unit · Part D plans $0.7627/unit — full pricing hub ↓
Also comes in: 15 g 16714-0996-01
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 16714-996-02
Product NDC 16714-996
11-digit billing NDC 16714099602
NCPDP billing unit GM — per gram (weight)
RxCUI 238920
UNII 826Y60901U
UPC 0316714996011
Application # ANDA208885
SPL Set ID 395d40c0-22d9-48d1-8d8e-eeaddf33c53e
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-10-10
Route TOPICAL
Dosage form CREAM
Substance BETAMETHASONE DIPROPIONATE
GPI-14 90550020003705
GPI class Betamethasone Dipropionate
GCN Seq No 007568
GCN 31060
HICL code 003304
Ingredient (HICL) Betamethasone Dipropionate
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5P
Therapeutic class — specific (HIC3) Topical Anti-Inflammatory Steroidal
AHFS code 68:04.00.00
AHFS class Adrenals
FDB label name BETAMETHASONE DP 0.05% CRM
FDB brand name Betamethasone Dipropionate
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 16714-996-02 — 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 → 16714-0996-02. 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 Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids acting locally, Corticosteroids, Corticosteroids, potent (group III)
How it works Corticosteroid Hormone Receptor Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerNorthstar Rx LLC.
Application holderZYDUS PHARMACEUTICALS USA INC
FDA applicationANDA208885 (ANDA)
Labeler code16714
First marketedOct 2019
Product typeHuman Prescription Drug
Portfolio28 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 BETAMETHASONE DP 0.05% CRM Ingredient Betamethasone Dipropionate
📗 Our plain-language guide HelloPharmacist
  • Betamethasone is a steroid cream (or ointment, gel, spray, or foam) that treats skin conditions where inflammation is the problem — things like eczema, psoriasis, and other conditi...
  • What skin conditions does betamethasone treat?
  • For creams and ointments, apply a thin layer to the affected area once or twice a day — less is more with these products. For the spray (like Sernivo), shake it well first, spray o...
  • That depends on the product. Most creams and ointments should be used for no more than 2 consecutive weeks. The spray forms — including Sernivo — are approved for up to 4 weeks. Yo...
📖 Read our full Betamethasone guide →
8
Nutrient depletion considerations

Betamethasone Dipropionate may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

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.

🧪 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 I835H2IHHX
    A waxy substance derived from plant oils, used as an emulsifier and solubilizer to help mix oil and water ingredients together and keep them blended throughout the product's shelf life.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII 36W53O7109
    Chlorocresol is a phenolic antimicrobial chemical used as a preservative in liquid medicines and injectable solutions. It prevents bacterial and fungal growth to maintain product safety and shelf-life.
  • 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 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
  • UNII 3980JIH2SW
    A salt form of phosphoric acid that acts as a buffer and pH adjuster in medicines. It helps keep the product at the correct acidity level for stability and effectiveness.
  • 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.

7 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 DailyMedingredient 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 systemPer gPer package
Retail pharmacies payNADAC · weekly $0.375 $16.88 / 45 g
Medicaid paysCMS SDUD · 12 mo $0.6209 $27.94 / 45 g
Medicare drug plans payPart D · Q2 2026 $0.7627 $34.32 / 45 g
NADAC price history (per g) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.765 $0.375
▼ Down 51% over the last 24 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Betamethasone Dipropionate .5 mg/g 45802-0376-32 Padagis 1 tube $0.118 AB Availability likely save 69%
Betamethasone Dipropionate .5 mg/g 68462-0290-17 Glenmark 15 g $0.200 FDA listed save 47%
Betamethasone Dipropionate .5 mg/g 51672-1310-01 Sun 1 tube $0.213 AB Availability likely save 43%
Betamethasone Dipropionate .5 mg/g 45802-0021-46 Padagis 56.2 g $0.296 AB Availability likely save 21%
Betamethasone dipropionate .5 mg/gthis 16714-0996-02 Northstar 1 tube $0.375 AB Availability likely
Betamethasone Dipropionate .5 mg/g 00168-0055-15 E. 1 tube $0.481 AB Availability likely +28%
Betamethasone Dipropionate .5 mg/g 00472-0380-15 Actavis 1 tube $0.481 AB Availability likely +28%
Betamethasone Dipropionate .5 mg/g 00713-0659-15 Cosette 1 tube $0.481 AB Availability likely +28%
Betamethasone Dipropionate .5 mg/g 51672-1274-01 Sun 1 tube $0.481 AB Availability likely +28%
Betamethasone dipropionate .5 mg/g 70710-1233-01 Zydus 1 tube $0.481 AB Availability likely +28%
Betamethasone Dipropionate .5 mg/g 00472-0381-15 Actavis 1 tube $0.495 AB Availability likely +32%
betamethasone dipropionate .5 mg/g 72578-0093-01 Viona 1 tube $0.495 AB Availability likely +32%
Betamethasone Dipropionate .5 mg/g 00168-0056-15 E. 1 tube $0.495 AB Discontinued +32%
Betamethasone Dipropionate .5 mg/g 45802-0505-14 Padagis 1 tube $0.495 AB Availability likely +32%
Betamethasone Dipropionate .5 mg/g 00472-0382-15 Actavis 1 tube $0.578 AB Discontinued +54%
Betamethasone Dipropionate .5 mg/g 35573-0107-15 Burel 1 tube $0.578 AB Availability likely +54%
Betamethasone dipropionate .5 mg/g 68180-0947-01 Lupin 1 tube $0.578 AB Availability likely +54%
Betamethasone Dipropionate .5 mg/g 00168-0268-15 E. 15 g $0.578 AB Availability likely +54%
Betamethasone Dipropionate .5 mg/g 66993-0897-15 Prasco 1 tube $0.578 AB Availability likely +54%
Betamethasone Dipropionate .5 mg/g 51672-1309-01 Sun 1 tube $2.632 AB Availability likely +602%
Betamethasone Dipropionate .5 mg/g 50090-0235-00 A-S 1 tube AB FDA listed
Betamethasone Dipropionate .5 mg/g 50090-2182-00 A-S 1 tube AB FDA listed
Betamethasone Dipropionate .5 mg/g 50090-3276-00 A-S 1 tube AB FDA listed
Betamethasone dipropionate .5 mg/g 50090-4680-00 A-S 1 tube AB FDA listed
Betamethasone dipropionate .5 mg/g 50090-7525-00 A-S 1 tube AB FDA listed
Betamethasone Dipropionate .5 mg/g 51407-0273-15 Golden 1 tube AB FDA listed
Betamethasone Dipropionate .5 mg/g 59651-0891-14 Aurobindo 1 tube AB FDA listed
Betamethasone Dipropionate .5 mg/g 70518-4187-00 REMEDYREPACK 1 tube AB FDA listed
Betamethasone dipropionate .5 mg/g 70771-1380-01 Zydus 1 tube AB FDA listed
betamethasone dipropionate .5 mg/g 70771-1550-01 Zydus 1 tube AB FDA listed
Betamethasone Dipropionate .5 mg/g 71205-0275-15 Proficient 1 tube AB FDA listed
Betamethasone Dipropionate .5 mg/g 50090-0236-00 A-S 1 tube AB FDA listed
Betamethasone Dipropionate .5 mg/g 63629-8614-01 Bryant 1 tube AB FDA listed
Betamethasone Dipropionate .5 mg/g 59651-0699-14 Aurobindo 1 tube AB FDA listed
Diprolene .5 mg/g 78206-0124-01 Organon 1 tube AB FDA listed
Betamethasone Dipropionate .5 mg/g 71335-2715-01 Bryant 1 tube AB FDA listed
Betamethasone Dipropionate .5 mg/g 72162-1415-02 Bryant 1 tube AB FDA listed
Betamethasone Dipropionate .5 mg/g 68071-4556-03 NuCare 30 g AB FDA listed
Betamethasone dipropionate .5 mg/g 50090-6787-00 A-S 1 tube AB FDA listed
Betamethasone Dipropionate .5 mg/g 76420-0858-15 Asclemed 1 tube AB FDA listed
Betamethasone Dipropionate .5 mg/g 63629-9324-01 Bryant 1 tube AB FDA listed
Betamethasone Dipropionate .5 mg/g 68788-7670-05 Preferred 1 tube AB FDA listed
Betamethasone Dipropionate .5 mg/g 50090-7517-00 A-S 50 g AB FDA listed
Betamethasone Dipropionate .5 mg/g 68788-9219-01 Preferred 1 tube AB FDA listed
Betamethasone Dipropionate .5 mg/g 72162-1405-02 Bryant 1 tube AB FDA listed
Betamethasone Dipropionate .5 mg/g 63629-8613-01 Bryant 1 tube AB FDA listed
Betamethasone Dipropionate .5 mg/g 50090-5232-00 A-S 1 tube AB FDA listed
Betamethasone Dipropionate .5 mg/g 63629-9323-01 Bryant 1 tube AB FDA listed
Betamethasone Dipropionate .5 mg/g 68071-4814-05 NuCare 15 g AB FDA listed
Betamethasone dipropionate .5 mg/g 67296-2275-01 Redpharm 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

🏛️
2019
On the market since
Oct 2019
📍
2026
Currently FDA-listed
7 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.

🗺️ 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 16714-0996-02, 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
4K
Units reimbursed last 4 qtrs
193.4K
Gross reimbursed last 4 qtrs
$120.1K
Avg / prescription
$30.32
Avg / unit
$0.6209
Latest quarter Q4 2025
888Rx
Medicaid pays / g
$0.6209
gross reimbursed
vs
NADAC / g
$0.3752
acquisition cost
=
Spread
+$0.2457
+65% 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
57% FFS 43% MCO
Fee-for-service · 2,264 Rx Managed care · 1,697 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: 3,150 units · 160 per 100k residents ID Montana: no data reported MT North Dakota: 460 units · 58.7 per 100k residents ND Minnesota: 5,085 units · 88.6 per 100k residents MN Wisconsin: no data reported WI Michigan: 35,210 units · 351 per 100k residents MI New York: 50,385 units · 257 per 100k residents NY Vermont: 2,835 units · 438 per 100k residents VT New Hampshire: no data reported NH Oregon: 7,515 units · 178 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 540 units · 16.8 per 100k residents IA Illinois: no data reported IL Indiana: 1,485 units · 21.6 per 100k residents IN Ohio: no data reported OH Pennsylvania: 8,145 units · 62.8 per 100k residents PA New Jersey: no data reported NJ Massachusetts: 1,860 units · 26.6 per 100k residents MA California: 50,375 units · 129 per 100k residents CA Utah: no data reported UT Colorado: 2,220 units · 37.8 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 7,035 units · 155 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 3,600 units · 48.4 per 100k residents AZ New Mexico: 1,035 units · 49.0 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: 1,035 units · 25.5 per 100k residents OK Louisiana: 1,845 units · 40.3 per 100k residents LA Mississippi: 1,395 units · 47.4 per 100k residents MS Alabama: 3,510 units · 68.7 per 100k residents AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 4,680 units · 15.3 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
15.3438
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 Vermont 438 /100k
2 Michigan 351 /100k
3 New York 257 /100k
4 Oregon 178 /100k
5 Idaho 160 /100k
6 Kentucky 155 /100k
7 California 129 /100k
8 Minnesota 88.6 /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.

💊 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 tube this page16714-0996-02 3,961 Rx · $120,089
1 tube16714-0996-01 3,732 Rx · $85,160
Drug total (last 4 qtrs): 7,693 Rx · 297,213 units · $205,249 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 Betamethasone Dipropionate — the program that covers self-administered drugs. 9 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 Betamethasone Dipropionate. 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
$6.42M
Claims incl. refills
175.3K
Beneficiaries
137.3K
Spend / beneficiary
$46.78
Spend / claim
$36.64
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 BETAMETHASONE DIPROPIONATE — the ingredient across all brands.

Top reported reactions

Psoriasis1,124
Nausea709
Pruritus640
Pain620
Headache585
Diarrhoea580
Fatigue573

Age at onset

Neonate11
Infant4
Child51
Adolescent45
Adult1,534
Elderly821

Reporter sex

10,032 reports
Male · 42%
Female · 58%
Unknown · 0%

Serious outcomes

Hospitalization2,756
Death656
Life-threatening504
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 1,144 0
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 NDCDescription Per unit Per pack Marketing startStatus
16714-0996-01 1 TUBE in 1 CARTON (16714-996-01) / 15 g in 1 TUBE $0.4806 / g $7.21 2019-10-10 Active
16714-0996-02 You're viewing this 1 TUBE in 1 CARTON (16714-996-02) / 45 g in 1 TUBE $0.3752 / g $16.88 2019-10-10 Active

This pack has the lowest per-g cost of the 2 priced pack sizes ($0.3752 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 51% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 16714-0996-02?
NDC 16714-0996-02 is listed by the FDA — 1 tube in 1 carton / 45 g in 1 tube.
What NDC number is used to bill for this package of Betamethasone dipropionate .5 mg/g Cream?
Bill NDC 16714-0996-02 — the 11-digit billing format is 16714099602. 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.

📄 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 19 words

INDICATIONS AND USAGE Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

⏱️ Dosage and Administration 47 words

DOSAGE AND ADMINISTRATION Apply a thin film of betamethasone dipropionate cream to the affected skin areas once daily. In some cases, twice daily dosage may be necessary. If an infection develops, appropriate antimicrobial therapy should be instituted. Betamethasone dipropionate products should not be used with occlusive dressings.

Contraindications 21 words

CONTRAINDICATIONS Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

🤒 Adverse Reactions 82 words

ADVERSE REACTIONS The following local adverse reactions are reported infrequently when betamethasone dipropionate products are used as recommended in the DOSAGE AND ADMINISTRATION section. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infections, skin atrophy, striae and miliaria. Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia and glucosuria in some patients.

🧒 Pediatric Use 116 words

Pediatric Use Pediatric patients may demonstrate greater susceptibility to topical corticosteroid induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation.

Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

🆘 Overdosage 17 words

OVERDOSAGE Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS ).

🧬 Clinical Pharmacology 178 words

CLINICAL PHARMACOLOGY Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids.

There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin.

Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids (See DOSAGE AND ADMINISTRATION ). Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids.

Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

📦 How Supplied / Storage and Handling 100 words

HOW SUPPLIED Each gram contains betamethasone dipropionate 0.64 mg equivalent to betamethasone, USP 0.5 mg. Betamethasone Dipropionate Cream USP, 0.05% is white to off white cream, free from lumps and foreign matter with no phase separation is supplied as: NDC 16714-996-01 in tube of 15 g NDC 16714-996-02 in tube of 45 g Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and freezing.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Please address medical inquiries to Northstar Rx LLC at Tel.: 1-800-206-7821.

📋 Description 127 words

DESCRIPTION Betamethasone dipropionate cream USP, 0.05% contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate, USP is a white to almost white crystalline powder.

It is practically insoluble in water, sparingly soluble in alcohol and freely soluble in acetone, methylene chloride and chloroform. Chemically, it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate. The structural formula is: Molecular Formula : C 28 H 37 FO 7 Molecular Weight : 504.60 Each gram contains 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone) in a white to off-white cream of cetomacrogol 1000, cetostearyl alcohol, mineral oil, purified water, sodium phosphate monobasic, white petrolatum and chlorocresol is present as preservative.

Image

💬 Information for Patients 118 words

Information for Patients Patients using topical corticosteroids should receive the following information and instructions: This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.

Patients should be advised not to use this medication for any disorder other than that for which it was prescribed. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive. Patients should report any signs of local adverse reactions.

Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings (See DOSAGE AND ADMINISTRATION ).

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