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Hydrocortisone 25 mg/g Cream

by Actavis Pharma, Inc. · 1 TUBE in 1 CARTON (0472-0337-30) / 30 g in 1 TUBE
NDC 00472-0337-30
🏷️ FDA NDC (as labeled) 0472-0337-30 billing pads the labeler segment with a zero
This package
Contains30 g in 1 tube Cost per g$0.0922 NADAC Per package$2.77 / 30 g Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.5941/unit — full pricing hub ↓
Also comes in: 20 g 00472-0337-20
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Jul 2, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Jun 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 0472-0337-30
Product NDC 0472-0337
11-digit billing NDC 00472033730
NCPDP billing unit GM — per gram (weight)
RxCUI 310891
UNII WI4X0X7BPJ
Application # ANDA089682
SPL Set ID a5f16c13-2a51-4541-bf9e-d80bc01a8dbd
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Jun 2026)
Marketing start 2002-09-30
Marketing end 2026-06-30
Route TOPICAL
Dosage form CREAM
Substance HYDROCORTISONE
GPI-14 90550075003725
GPI class Hydrocortisone
GCN Seq No 007545
GCN 30943
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% CREAM
FDB brand name Hydrocortisone
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 0472-0337-30 — a 4-4-2 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 labeler segment → 00472-0337-30. 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.

🏭 Manufacturer & labeler

LabelerActavis Pharma, Inc.
Application holderACTAVIS MID ATLANTIC LLC
FDA applicationANDA089682 (ANDA)
Labeler code00472
First marketedSep 2002
Product typeHuman Prescription Drug
Portfolio324 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 HYDROCORTISONE 2.5% CREAM Ingredient Hydrocortisone
📖 What it is MedlinePlus · NLM

Hydrocortisone topical is used to treat redness, swelling, itching, and discomfort of various skin conditions. Hydrocortisone is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It's designed to calm down inflammation — so the redness, swelling, and itching that come with conditions like eczema should ease up, usually within a few days of consistent use. I...
  • What exactly is this cream supposed to do for my skin?
  • That's a really important question. Hydrocortisone is generally meant for short courses — typically a few weeks. Long-term or widespread use can cause side effects like skin thinni...
  • How long can I keep using it? Is it okay to use every day long-term?
📖 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.

🧪 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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

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

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly $0.092 $2.77 / 30 g
Medicaid paysCMS SDUD · 12 mo $0.5941 $17.82 / 30 g
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per g) — tap or hover for the price & month
Dec 2021 Jul 2022 Feb 2024 Jun 2026 $0.092 $0.080
▲ Up 7% over the last 22 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
Hydrocortisone 25 mg/gthis 00472-0337-30 Actavis 1 tube $0.092 — Discontinued —
Hydrocortisone 25 mg/g 00168-0146-16 E. 454 g $0.099 AT FDA listed +7%
Hydrocortisone 25 mg/g 00168-0080-16 E. 454 g $0.107 AT Availability likely +17%
Hydrocortisone 25 mg/g 45802-0014-02 Padagis 1 tube $0.123 AT Availability likely +33%
Hydrocortisone 25 mg/g 45802-0004-02 Padagis 1 tube $0.125 AT Availability likely +36%
Hydrocortisone 25 mg/g 62559-0431-30 ANI 1 tube $0.237 AT Availability likely +157%
Proctozone-Hc 25 mg/g 64980-0324-30 Rising 1 tube $0.237 AT Availability likely +157%
Procto-Med HC 25 mg/g 69315-0312-28 Leading 1 tube $0.237 AT Availability likely +157%
Proctosol-HC 25 mg/g 10631-0407-01 Sun 1 tube $0.546 AT Availability likely +492%
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 50090-0244-00 A-S 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 50090-0350-00 A-S 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 50090-2452-00 A-S 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 50090-5999-00 A-S 1 tube — — FDA listed —
Hydrocortisone 25 mg/g 51672-3003-00 Sun 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 61919-0364-30 DIRECT 30 g — AT FDA listed —
Hydrocortisone 25 mg/g 63187-0480-20 Proficient 1 tube — — FDA listed —
Hydrocortisone 25 mg/g 63629-1952-01 Bryant 1 tube — AT FDA listed —
Proctozone-Hc 25 mg/g 63629-2396-01 Bryant 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 63629-8666-01 Bryant 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 63629-8667-01 Bryant 1 tube — AT FDA listed —
Proctozone-Hc 25 mg/g 63629-8847-01 Bryant 1 tube — AT FDA listed —
Anusol HC 25 mg/g 65649-0401-30 Salix 1 tube — 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 —
Procto-Med HC 25 mg/g 68071-3968-01 NuCare 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 68071-4511-02 NuCare 20 g — — FDA listed —
Proctozone-Hc 25 mg/g 68788-7091-03 Preferred 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 68788-8302-03 Preferred 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 68788-8583-02 Preferred 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 68788-9922-03 Preferred 1 tube — AT Discontinued —
Hydrocortisone 25 mg/g 70518-3078-00 REMEDYREPACK 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 71335-2954-01 Bryant 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 72162-1382-02 Bryant 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 72162-1764-03 Bryant 1 tube — AT FDA listed —
Proctozone-Hc 25 mg/g 72162-1805-02 Bryant 1 tube — AT FDA listed —
Proctosol-HC 25 mg/g 72162-2165-02 Bryant 1 tube — AT FDA listed —
Hydrocortisone Cream 25 mg/g 72189-0554-28 Direct_Rx 20 g — AT FDA listed —
Hydrocortisone Cream 25 mg/g 72189-0625-30 Direct_Rx 1 g — AT FDA listed —
Hydrocortisone 25 mg/g 82804-0135-28 Proficient 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 85766-0081-30 Sportpharm 30 g — AT FDA listed —
Hydrocortisone 25 mg/g 85766-0085-30 Sportpharm 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 63629-8817-01 Bryant 29 g — AT FDA listed —
Hydrocortisone 25 mg/g 82804-0084-20 Proficient 1 tube — AT FDA listed —
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 72162-1383-04 Bryant 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 63629-9057-01 Bryant 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 63629-2528-01 Bryant 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

🏛️
2002
On the market since
Sep 2002
📍
2026
Currently FDA-listed
24 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 00472-0337-30, 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
5.1K
Units reimbursed last 4 qtrs
181.7K
Gross reimbursed last 4 qtrs
$107.9K
Avg / prescription
$21.05
Avg / unit
$0.5941
Latest quarter Q1 2026
388Rx
Medicaid pays / g
$0.5941
gross reimbursed
vs
NADAC / g
$0.0922
acquisition cost
=
Spread
+$0.5019
+544% 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 ⓘ
55% FFS 45% MCO
Fee-for-service · 2,822 Rx Managed care · 2,306 Rx
State Medicaid map
Alaska: 4,020 units · 548 per 100k residents AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 988 units · 17.2 per 100k residents MN Wisconsin: 960 units · 16.2 per 100k residents WI Michigan: 15,554 units · 155 per 100k residents MI New York: 63,812 units · 326 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 2,350 units · 73.6 per 100k residents NV Wyoming: no data reported WY South Dakota: 1,528 units · 166 per 100k residents SD Iowa: 450 units · 14.0 per 100k residents IA Illinois: 2,760 units · 22.0 per 100k residents IL Indiana: no data reported IN Ohio: 2,215 units · 18.8 per 100k residents OH Pennsylvania: 6,450 units · 49.8 per 100k residents PA New Jersey: 7,046 units · 75.8 per 100k residents NJ Massachusetts: no data reported MA California: 21,801 units · 56.0 per 100k residents CA Utah: no data reported UT Colorado: 600 units · 10.2 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 2,064 units · 45.6 per 100k residents KY West Virginia: 996 units · 56.3 per 100k residents WV Virginia: 3,118 units · 35.8 per 100k residents VA Maryland: 4,936 units · 79.9 per 100k residents MD Connecticut: 840 units · 23.2 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: 810 units · 26.4 per 100k residents AR Tennessee: 1,200 units · 16.8 per 100k residents TN North Carolina: 12,205 units · 113 per 100k residents NC South Carolina: 1,950 units · 36.3 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 2,760 units · 60.3 per 100k residents LA Mississippi: 898 units · 30.5 per 100k residents MS Alabama: 1,078 units · 21.1 per 100k residents AL Georgia: 3,890 units · 35.3 per 100k residents GA D.C.: 598 units · 88.1 per 100k residents DC Hawaii: no data reported HI Texas: 7,101 units · 23.3 per 100k residents TX Florida: 5,816 units · 25.7 per 100k residents FL
Units reimbursed · per 100k residents
10.2548
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 Alaska 548 /100k
2 New York 326 /100k
3 South Dakota 166 /100k
4 Michigan 155 /100k
5 North Carolina 113 /100k
6 D.C. 88.1 /100k
7 Maryland 79.9 /100k
8 New Jersey 75.8 /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 tube00472-0337-20 8,718 Rx · $82,888
1 tube this page00472-0337-30 5,128 Rx · $107,928
Drug total (last 4 qtrs): 13,846 Rx · 405,246 units · $190,816 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.

🔬 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 Hydrocortisone — the ingredient across all brands.

Top reported reactions

Fatigue12,539
Pain10,830
Arthralgia9,700
Nausea9,667
Diarrhoea9,066
Rash9,002
Condition Aggravated8,913

Age at onset

Neonate382
Infant378
Child1,276
Adolescent928
Adult13,999
Elderly6,577

Reporter sex

123,954 reports

Serious outcomes

Hospitalization47,559
Life-threatening12,667
Disabling10,100
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 9,888 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
00472-0337-20 1 TUBE in 1 CARTON (0472-0337-20) / 20 g in 1 TUBE $0.1255 / g $2.51 2002-09-30 Discontinued by firm
00472-0337-30 You're viewing this 1 TUBE in 1 CARTON (0472-0337-30) / 30 g in 1 TUBE $0.0922 / g $2.77 2002-09-30 Discontinued by firm

This pack has the lowest per-g cost of the 2 priced pack sizes ($0.0922 NADAC).

This pack accounts for about 37% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in NDC 00472-0337-30?
NDC 00472-0337-30 is listed by the FDA — 1 tube in 1 carton / 30 g in 1 tube.
What NDC number is used to bill for this package of Hydrocortisone 25 mg/g Cream?
Bill NDC 00472-0337-30 — the 11-digit billing format is 00472033730. 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.

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) ✓ Available
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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) ✓ Available
“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

What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 0472-0337-30, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00472-0337-30, written without dashes as 00472033730. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00472-0337-30, the first segment (00472) is the labeler code FDA assigned to Actavis Pharma, Inc.; the middle segment (0337) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 tube (00472-0337-20). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Actavis Pharma, 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.

📄 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 📋 Description 💬 Information for Patients
🎯 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 59 words ▾

DOSAGE AND ADMINISTRATION Topical corticosteroids are generally applied to the affected area as a thin film from 2 to 4 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 80 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 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. To report SUSPECTED ADVERSE EVENTS, contact Actavis at 1-888-838-2872 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch for voluntary reporting of adverse reactions.

🤰 Pregnancy 92 words ▾

Pregnancy Teratogenic Effects: 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 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 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 children.

🆘 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 to 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 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 46 words ▾

HOW SUPPLIED Hydrocortisone Cream USP, 2.5% 20 g (0.7 oz) tube NDC 0472-0337-20 30 g (1.1 oz) tube NDC 0472-0337-30 Store at controlled room temperature 15° to 30°C (59° to 86°F). Do not freeze. Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Rev. A 7/2020

📋 Description 119 words ▾

DESCRIPTION The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Hydrocortisone cream is a member of this class. Hydrocortisone cream contains the synthetic steroid hydrocortisone (Pregn-4-ene-3,20-dione, 11, 17, 21-trihydroxy-, (11ß)-) which has a molecular formula of C 21 H 30 O 5 , a molecular weight of 362.46 and CAS Registry Number 50-23-7.

Each gram of the 2.5% cream contains 25 mg of hydrocortisone, USP in a cream base of cetyl alcohol, citric acid, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, sorbic acid, sorbitan monostearate, stearyl alcohol, white wax and citric acid solution and sodium citrate solution to adjust pH. chem structure

💬 Information for Patients 122 words ▾

Information for the Patient 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 for which it was prescribed. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.

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

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00472-0321-26 · Actavis 00472-0379-15 · Actavis →
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.