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Hydrocortisone 25 mg/g Ointment, 454 g — NDC 45802-0014-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Hydrocortisone 25 mg/g Ointment, 454 g — NDC 45802-014-05 (Billing 45802-0014-05)

by Padagis Israel Pharmaceuticals Ltd · 454 g in 1 JAR

This is a package of 454 g of Hydrocortisone 25 mg/g Ointment from Padagis Israel Pharmaceuticals Ltd, marketed since Jun 2006 and currently FDA-listed; retail pharmacies pay about $0.0656 per g (NADAC).

NDC 45802-0014-05
🏷️ FDA NDC (as labeled) 45802-014-05 billing pads the product segment with a zero
This package
Contains454 g Cost per g$0.0656 NADAC Per package$29.78 / 454 g Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.0859/unit · Part D plans $0.1782/unit — full pricing hub ↓
Product page 45802-0014-02 Also comes in: 20 g 45802-014-02
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

NDC database record

One package, one record: these facts belong to NDC 45802-014-05 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
45802 labeler · 014 product · 05 package
Package marketed since
Dec 19, 2006
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
454 g per package
Barcode (UPC-A, from the NDC)
3 4580201405 4
Medicaid fills, this package
70,541 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 45802-014-05
Product NDC 45802-014
11-digit billing NDC 45802001405
NCPDP billing unit GM — per gram (weight)
RxCUI 103401, 310891
UNII WI4X0X7BPJ
Application # ANDA085027
SPL Set ID 7ba59aa6-b828-4048-bf86-90c90d9894a0
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 2006-06-13
Route TOPICAL
Dosage form OINTMENT
Substance HYDROCORTISONE
TE code (Orange Book) AT · RLD · RS

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

GPI-14 90550075004215
GPI class Hydrocortisone
GCN Seq No 007548
GCN 30952
HICL code 002867
Ingredient (HICL) Hydrocortisone
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 52:08.08.00
AHFS class Corticosteroids (Eent)
FDB label name HYDROCORTISONE 2.5% OINTMENT
FDB brand name Hydrocortisone
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 007548
  • GCN: 30952
  • GPI-14 (Medi-Span): 90550075004215
  • HICL (First Databank): 002867
  • AHFS class code: 52:08.08.00
  • RxCUI (RxNorm): 103401
Why two NDCs? The FDA registers this code as 45802-014-05 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 45802-0014-05. 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, moderately potent (group II), Corticosteroids, potent (group III), Corticosteroids for local oral treatment
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.

Clinical

Label name HYDROCORTISONE 2.5% OINTMENT Ingredient Hydrocortisone
📗 Our plain-language guide HelloPharmacist
  • It depends on the product. Tablets and oral granules are used for adrenal insufficiency, among other conditions. Injections are used for severe allergic states and skin diseases. R...
  • Don't stop it suddenly if you take it for adrenal insufficiency. Stopping abruptly can cause adrenal crisis, which can be fatal. Talk to your prescriber before making any changes.
  • Common ones are fluid retention, higher blood pressure, changes in blood sugar, mood changes, bigger appetite and weight gain. Call your doctor for signs of infection, vision chang...
  • Grapefruit juice and some antifungals and antibiotics can raise hydrocortisone levels. Some seizure medicines and rifampicin can lower them. Tell me about any diabetes medicines, w...
📖 Read our full Hydrocortisone guide →
8
Nutrient depletion considerations

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

🧪 Full Hydrocortisone 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 $0.066 $29.78 / 454 g
Medicaid paysCMS SDUD · 12 mo $0.0859 $39.00 / 454 g
Medicare drug plans payPart D · Q2 2026 $0.1782 $80.90 / 454 g
NADAC price history (per g) — tap or hover for the price & month
Dec 2021 Sep 2022 Feb 2026 Sep 2026 $0.069 $0.062
▼ Down 4% over the last 21 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
45802-0014-02 45802-014-02 Main listing 1 TUBE in 1 CARTON / 20 g in 1 TUBE $0.1217 / g $2.43 2006-06-13 — Active
45802-0014-05 You're viewing this 454 g in 1 JAR $0.0656 / g $29.80 2006-12-19 — Active

This pack has the lowest per-g cost of the 2 priced pack sizes ($0.0656 NADAC).

This pack accounts for about 17% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package contains 454 g — 454 g in 1 jar.
What NDC number is used to bill for this package of Hydrocortisone 25 mg/g Ointment?
Use the 11-digit billing form listed in the identifiers section of this page. 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Hydrocortisone 25 mg/gthis 45802-0014-05 Padagis 454 g $0.066 AT Availability likely —
Hydrocortisone 25 mg/g 00168-0146-16 E. 454 g $0.099 AT FDA listed +50%
Hydrocortisone 25 mg/g 00168-0080-16 E. 454 g $0.109 AT Availability likely +66%
Hydrocortisone 25 mg/g 00472-0337-20 Actavis 1 tube $0.125 — Discontinued +91%
Hydrocortisone 25 mg/g 45802-0004-02 Padagis 1 tube $0.126 AT Availability likely +91%
Hydrocortisone 25 mg/g 62559-0431-30 ANI 1 tube $0.235 AT Availability likely +258%
Procto-Med HC 25 mg/g 69315-0312-28 Leading 1 tube $0.235 AT Availability likely +258%
Proctosol-HC 25 mg/g 10631-0407-01 Sun 1 tube $0.698 AT Availability likely +964%
Hydrocortisone 25 mg/g 50090-0527-00 A-S 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 63629-2527-01 Bryant 454 g — AT FDA listed —
Hydrocortisone 25 mg/g 63629-2528-01 Bryant 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 63629-8817-01 Bryant 29 g — AT FDA listed —
Hydrocortisone 25 mg/g 63629-9057-01 Bryant 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 72162-1383-04 Bryant 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 82804-0084-20 Proficient 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 63187-0480-20 Proficient 1 tube — — FDA listed —
Hydrocortisone 25 mg/g 50090-5999-00 A-S 1 tube — — FDA listed —
Anusol HC 25 mg/g 65649-0401-30 Salix 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 61919-0364-30 DIRECT 30 g — AT FDA listed —
Hydrocortisone 25 mg/g 66267-0967-01 NuCare 30 g — AT FDA listed —
Hydrocortisone 25 mg/g 68071-2233-01 NuCare 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 72162-1382-02 Bryant 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 50090-2452-00 A-S 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 68788-9922-03 Preferred 1 tube — AT Discontinued —
Hydrocortisone 25 mg/g 50090-0350-00 A-S 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 85766-0081-30 Sportpharm 30 g — AT FDA listed —
Hydrocortisone 25 mg/g 63629-8667-01 Bryant 1 tube — AT FDA listed —
Alacort 25 mg/g 00316-0128-16 Crown 454 g — AT FDA listed —
Hydrocortisone 25 mg/g 00316-0193-16 Crown 1 jar — AT FDA listed —
Hydrocortisone 25 mg/g 68788-8583-02 Preferred 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 72162-1764-03 Bryant 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 85766-0085-30 Sportpharm 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 63629-1952-01 Bryant 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 68071-4511-02 NuCare 20 g — — FDA listed —
Hydrocortisone 25 mg/g 71335-2954-01 Bryant 1 tube — AT FDA listed —
Procto-Med HC 25 mg/g 68071-3968-01 NuCare 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 70518-3078-00 REMEDYREPACK 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 68788-8302-03 Preferred 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 50090-0244-00 A-S 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 51672-3003-00 Sun 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 63629-8666-01 Bryant 1 tube — AT FDA listed —
Proctosol-HC 25 mg/g 72162-2165-02 Bryant 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 82804-0135-28 Proficient 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 21922-0065-05 Encube 1 tube — AT 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

🏛️
2006
On the market since
Jun 2006
📍
2026
Currently FDA-listed
20 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII N6K5787QVP
    Light mineral oil is a clear, odorless liquid derived from petroleum. In medicines, it acts as a lubricant and emollient to help the product spread smoothly and improve texture.
  • 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.

2 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

LabelerPadagis Israel Pharmaceuticals Ltd
Application holderPADAGIS US LLC
FDA applicationANDA085027 (ANDA)
Labeler code45802
First marketedJun 2006
Product typeHuman Prescription Drug
Portfolio175 products on file

More NDCs from Padagis Israel Pharmaceuticals Ltd labeler code 45802

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 19 words ▾

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

⏱️ Dosage and Administration 59 words ▾

DOSAGE AND ADMINISTRATION Topical corticosteroids are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

⛔ 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 60 words ▾

ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. 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 infection, skin atrophy, striae, and miliaria.

🤰 Pregnancy 96 words ▾

Pregnancy: Teratogenic Effects: Pregnancy Category C - Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids.

Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

🧒 Pediatric Use 119 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 pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients 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 pediatric patients.

🆘 Overdosage 17 words ▾

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

🧬 Clinical Pharmacology 193 words ▾

CLINICAL PHARMACOLOGY Topical corticosteroids share anti-inflammatory, antipruritic, 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. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses (see DOSAGE AND ADMINISTRATION ).

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systematically 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 48 words ▾

HOW SUPPLIED Hydrocortisone Cream USP, 2.5% is available as follows: 20 g tube (NDC 45802- 004 -02) 1 oz. (28 g) tube (NDC 45802- 004 -03) Hydrocortisone Ointment USP, 2.5% is available as follows: 20 g tube (NDC 45802- 014 -02) 1 lb. jar (NDC 45802- 014 -05)

📦 Storage and Handling 17 words ▾

STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Keep out of the reach of children.

📋 Description 110 words ▾

DESCRIPTION Each gram of Hydrocortisone Cream USP, 2.5% contains 25 mg of hydrocortisone in a cream base of cetyl alcohol, methylparaben, propylene glycol, propylparaben, purified water, sodium lauryl sulfate, and stearyl alcohol. Each gram of Hydrocortisone Ointment USP, 2.5% contains 25 mg of hydrocortisone in ointment base of light mineral oil and white petrolatum. Chemically, hydrocortisone is [Pregn-4-ene-3,20-dione,11,17,21-trihydroxy-, (11β)-] with the molecular formula (C 21 H 3O 0 5 ) and is represented by the following structural formula: Its molecular weight is 362.47 and its CAS Registry Number is 50-23-7.

The topical corticosteroids, including hydrocortisone, constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Chemical Formula

💬 Information for Patients ~2 min read ▾

Information for the Patient - Patients using topical corticosteroids should receive the following information and instructions: 1. This medication is to be used as directed by the physician. It is for external use only.

Avoid contact with the eyes. 2. Patients should be advised not to use this medication for any disorder other than for which it was prescribed.

3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. 4.

Patients should report any signs of local adverse reactions, especially under occlusive dressing. 5. 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.

Laboratory Tests The following tests may be helpful in evaluating the HPA axis suppression: Urinary free cortisol test ACTH stimulation test Carcinogenesis, Mutagenesis, Impairment of Fertility - Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results. Pregnancy: Teratogenic Effects: Pregnancy Category C - Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels.

The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time. Nursing Mothers - It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant.

Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman. 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 pediatric patients receiving topical corticosteroids.

Manifestations of adrenal suppression in pediatric patients 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 pediatric patients.

⚠️ Precautions ~1 min read ▾

PRECAUTIONS General - 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. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests.

If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see PRECAUTIONS - Pediatric Use ). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted.

If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

🍼 Nursing Mothers 59 words ▾

Nursing Mothers - It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

🧬 Pharmacokinetics 133 words ▾

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. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses (see DOSAGE AND ADMINISTRATION ). Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systematically 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.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 38 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility - Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

📄 Package Label / Principal Display Panel 50 words ▾

Principal Display Panel - Hydrocortisone Cream USP, 2.5% - 28 g NDC 45802-004-03 Rx Only Hydrocortisone Cream USP, 2.5% NET WT 28 g cream carton

Principal Display Panel - Hydrocortisone Ointment USP, 2.5% - 20 g NDC 45802-014-02 Rx Only Hydrocortisone Ointment USP, 2.5% NET WT 20 g ointment carton

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 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
70.5K
Units reimbursed last 4 qtrs
30.6M
Gross reimbursed last 4 qtrs
$2.63M
Avg / prescription
$37.28
Avg / unit
$0.0859
Latest quarter Q1 2026
17.2KRx
Medicaid pays / g
$0.0859
gross reimbursed
vs
NADAC / g
$0.0656
acquisition cost
=
Spread
+$0.0203
+31% 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 ⓘ
40% FFS 60% MCO
Fee-for-service · 28,149 Rx Managed care · 42,392 Rx
State Medicaid map
Alaska: 48,577 units · 6,627 per 100k residents AK Maine: 54,052 units · 3,875 per 100k residents ME Washington: 152,138 units · 1,947 per 100k residents WA Idaho: 10,492 units · 534 per 100k residents ID Montana: 27,129 units · 2,397 per 100k residents MT North Dakota: 30,659 units · 3,916 per 100k residents ND Minnesota: 464,359 units · 8,094 per 100k residents MN Wisconsin: 2,583,688 units · 43,717 per 100k residents WI Michigan: 1,541,713 units · 15,360 per 100k residents MI New York: 2,716,961 units · 13,883 per 100k residents NY Vermont: 79,930 units · 12,354 per 100k residents VT New Hampshire: 5,448 units · 389 per 100k residents NH Oregon: 78,249 units · 1,849 per 100k residents OR Nevada: 64,104 units · 2,007 per 100k residents NV Wyoming: 3,418 units · 585 per 100k residents WY South Dakota: 16,894 units · 1,838 per 100k residents SD Iowa: 234,237 units · 7,304 per 100k residents IA Illinois: 2,218,258 units · 17,677 per 100k residents IL Indiana: 504,712 units · 7,355 per 100k residents IN Ohio: 1,724,388 units · 14,632 per 100k residents OH Pennsylvania: 3,038,478 units · 23,443 per 100k residents PA New Jersey: 53,358 units · 574 per 100k residents NJ Massachusetts: 1,365,851 units · 19,509 per 100k residents MA California: 1,187,801 units · 3,048 per 100k residents CA Utah: 50,035 units · 1,464 per 100k residents UT Colorado: 365,568 units · 6,219 per 100k residents CO Nebraska: 128,556 units · 6,499 per 100k residents NE Missouri: 1,122,483 units · 18,116 per 100k residents MO Kentucky: 560,853 units · 12,392 per 100k residents KY West Virginia: 31,716 units · 1,792 per 100k residents WV Virginia: 669,139 units · 7,677 per 100k residents VA Maryland: 760,358 units · 12,304 per 100k residents MD Connecticut: 1,007,698 units · 27,860 per 100k residents CT Rhode Island: 71,762 units · 6,554 per 100k residents RI Arizona: 67,032 units · 902 per 100k residents AZ New Mexico: 48,644 units · 2,301 per 100k residents NM Kansas: 31,324 units · 1,065 per 100k residents KS Arkansas: no data reported AR Tennessee: 1,391,743 units · 19,530 per 100k residents TN North Carolina: 1,195,371 units · 11,032 per 100k residents NC South Carolina: 251,165 units · 4,675 per 100k residents SC Delaware: 229,824 units · 22,291 per 100k residents DE Oklahoma: 248,781 units · 6,138 per 100k residents OK Louisiana: 235,389 units · 5,146 per 100k residents LA Mississippi: 301,390 units · 10,251 per 100k residents MS Alabama: 696,299 units · 13,632 per 100k residents AL Georgia: 1,268,728 units · 11,504 per 100k residents GA D.C.: 77,466 units · 11,409 per 100k residents DC Hawaii: no data reported HI Texas: 1,443,642 units · 4,733 per 100k residents TX Florida: 159,353 units · 705 per 100k residents FL
Units reimbursed · per 100k residents
38943,717
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 Wisconsin 43,717 /100k
2 Connecticut 27,860 /100k
3 Pennsylvania 23,443 /100k
4 Delaware 22,291 /100k
5 Tennessee 19,530 /100k
6 Massachusetts 19,509 /100k
7 Missouri 18,116 /100k
8 Illinois 17,677 /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 tube45802-0014-02 346,673 Rx · $2,912,352
454 g this page45802-0014-05 70,541 Rx · $2,629,960
Drug total (last 4 qtrs): 417,214 Rx · 41,477,272 units · $5,542,311 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 Hydrocortisone — the program that covers self-administered drugs. 17 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 Hydrocortisone. 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
$19.92M
Claims incl. refills
699.9K
Beneficiaries
529.9K
Spend / beneficiary
$37.60
Spend / claim
$28.47
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.
← 45802-0009-10 · Padagis 45802-0021-46 · Padagis →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.