HomeNDC LookupIngredientsTriamcinolone Acetonide › 63629-8779-01
Triamcinolone acetonide 1 mg/g Cream, 30 g — NDC 63629-8779-01 package photo

Triamcinolone acetonide 1 mg/g Cream, 30 g

by Bryant Ranch Prepack · 30 g in 1 TUBE (63629-8779-1)
NDC 63629-8779-01
🏷️ FDA NDC (as labeled) 63629-8779-1 billing pads the package segment with a zero
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 →
⚠️
Other active recalls for Triamcinolone Acetonide (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Sep 28, 2023 — Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. The piece of glass appears to be roughly 1 cm x 0.5 cm inside the vial. (Eugia US LLC) · FDA recall D-0041-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 63629-8779-1
Product NDC 63629-8779
11-digit billing NDC 63629877901
NCPDP billing unit GM — per gram (weight)
RxCUI 1014314
UNII F446C597KA
Application # ANDA088042
SPL Set ID ad88de0e-6e01-4056-b259-841fb67d2db0
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 2012-04-01
Route TOPICAL
Dosage form CREAM
Substance TRIAMCINOLONE ACETONIDE
GPI-14 90550085103710
GPI class Triamcinolone Acetonide
GCN Seq No 007594
GCN 31232
HICL code 002891
Ingredient (HICL) Triamcinolone Acetonide
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 48:10.08.00
AHFS class Corticosteroids (Respiratory Tract)
FDB label name TRIAMCINOLONE 0.1% CREAM
FDB brand name Triamcinolone Acetonide
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AT · RLD · RS
Why two NDCs? The FDA registers this code as 63629-8779-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 63629-8779-01. 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 for local oral treatment, Corticosteroids, Corticosteroids, moderately potent (group II)
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

LabelerBryant Ranch Prepack
Application holderCROWN LABORATORIES INC
FDA applicationANDA088042 (ANDA)
Labeler code63629
First marketedApr 2012
Product typeHuman Prescription Drug
Portfolio4,434 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 TRIAMCINOLONE 0.1% CREAM Ingredient Triamcinolone Acetonide
📖 What it is MedlinePlus · NLM

Triamcinolone topical is used to treat the itching, redness, dryness, crusting, scaling, inflammation, and discomfort of various skin conditions, including psoriasis (a skin disease in which red, scaly patches form on some areas of the body and eczema (a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes). It is also used as a dental paste to relieve the discomfort of mouth sores. Triamcinolone 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
  • Yes, intra-articular triamcinolone is specifically approved to give short-term relief for knee arthritis, gout flares, bursitis, and similar joint conditions. The extended-release...
  • I'm getting a triamcinolone injection in my knee. Will it actually help, and how long does it last?
  • That's a really important thing to flag with your doctor before your injection or prescription. Triamcinolone can raise blood sugar — even in people whose diabetes is well-controll...
  • I have diabetes. Should I be worried about using triamcinolone?
📖 Read our full Triamcinolone guide →
8
Nutrient depletion considerations

Triamcinolone Acetonide 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 5ZA2S6B08X
    Cetyl palmitate is a waxy substance made from natural fats. It works as a binder and thickener to help hold the medicine together and control how it dissolves in your body.
  • 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 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII X045WJ989B
    Sorbic acid is a preservative derived from berries that prevents mold, yeast, and bacterial growth in medicines. It keeps the product stable and safe during storage.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • 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 Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.1230 $3.69 / 30 g
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Triamcinolone Acetonide 1 mg/g 45802-0064-05 Padagis 454 g $0.028 AT Availability likely
Triamcinolone Acetonide 1 mg/g 45802-0055-05 Padagis 454 g $0.035 AT Availability likely
triamcinolone acetonide 1 mg/g 00168-0004-15 E. 1 tube $0.100 AT Availability likely
Triamcinolone Acetonide 1 mg/g 00713-0225-15 Cosette 1 tube $0.100 AT Discontinued
Triamcinolone Acetonide 1 mg/g 16714-0986-01 NorthStar 1 tube $0.100 AT Availability likely
Triamcinolone Acetonide 1 mg/g 21922-0062-04 Encube 1 tube $0.100 AT Availability likely
Triamcinolone Acetonide 1 mg/g 33342-0329-15 Macleods 1 tube $0.100 AT Availability likely
Triamcinolone Acetonide 1 mg/g 51672-1282-01 Sun 1 tube $0.100 AT Availability likely
Triamcinolone Acetonide 1 mg/g 67877-0251-15 Ascend 15 g $0.100 AT Availability likely
Triamcinolone Acetonide 1 mg/g 71656-0042-15 Saptalis 1 tube $0.100 AT Availability likely
Triamcinolone acetonide 1 mg/g 33342-0333-15 Macleods 1 tube $0.119 AT Availability likely
Triamcinolone Acetonide 1 mg/g 51672-1284-01 Sun 1 tube $0.119 AT Availability likely
Triamcinolone Acetonide 1 mg/g 00713-0228-15 Cosette 1 tube $0.119 AT Availability likely
Triamcinolone acetonide 1 mg/g 16714-0276-01 NorthStar 1 tube $0.119 AT Availability likely
Triamcinolone Acetonide 1 mg/g 21922-0063-04 Encube 1 tube $0.119 AT Availability likely
Triamcinolone Acetonide 1 mg/g 00168-0006-15 E. 15 g $0.119 AT Availability likely
Triamcinolone Acetonide 1 mg/g 64980-0320-05 Rising 1 tube $2.686 AT Availability likely
Triderm 1 mg/g 00316-0170-01 Crown 1 tube AT FDA listed
Triamcinolone acetonide 1 mg/g 50090-0162-00 A-S 80 g AT FDA listed
Triamcinolone acetonide 1 mg/g 50090-0228-00 A-S 15 g AT FDA listed
Triamcinolone acetonide 1 mg/g 50090-2106-00 A-S 30000 mg AT FDA listed
Triamcinolone Acetonide 1 mg/g 50090-6547-00 A-S 1 tube AT FDA listed
Triamcinolone Acetonide 1 mg/g 50090-6566-00 A-S 454 g AT FDA listed
Triamcinolone Acetonide 1 mg/g 52817-0811-15 TruPharma, 1 tube AT FDA listed
Triamcinolone Acetonide 1 mg/g 61919-0234-30 Direct_Rx 30 g AT FDA listed
Triamcinolone Acetonide 1 mg/g 61919-0650-15 DIRECTRX 15 g AT FDA listed
Triamcinolone acetonide 1 mg/g 63187-0025-15 Proficient 15 g AT FDA listed
Triamcinolone Acetonide 1 mg/g 63187-0053-15 Proficient 15 g AT FDA listed
Triamcinolone Acetonide 1 mg/g 63187-0870-15 Proficient 1 tube FDA listed
Triamcinolone acetonide 1 mg/g 63629-8778-01 Bryant 15 g AT FDA listed
Triamcinolone acetonide 1 mg/gthis 63629-8779-01 Bryant 30 g AT FDA listed
Triamcinolone acetonide 1 mg/g 63629-8780-01 Bryant 80 g AT FDA listed
Triamcinolone acetonide 1 mg/g 63629-8781-01 Bryant 454 g AT FDA listed
Triamcinolone Acetonide 1 mg/g 63629-9573-01 Bryant 454 g AT FDA listed
Triamcinolone Acetonide 1 mg/g 63629-9574-01 Bryant 1 tube AT FDA listed
Triamcinolone Acetonide 1 mg/g 66267-0933-80 NuCare 80 g FDA listed
Triamcinolone Acetonide 1 mg/g 68071-2736-03 NuCare 1 tube AT FDA listed
Triamcinolone Acetonide 1 mg/g 68071-3666-03 NuCare 1 tube AT FDA listed
Triamcinolone Acetonide 1 mg/g 68071-3852-08 NuCare 1 tube AT FDA listed
Triamcinolone Acetonide 1 mg/g 68071-3982-05 NuCare 1 tube AT FDA listed
Triamcinolone Acetonide 1 mg/g 68071-4383-05 NuCare 15 g FDA listed
triamcinolone acetonide 1 mg/g 68071-4391-03 NuCare 30 g AT FDA listed
Triamcinolone Acetonide 1 mg/g 68071-4945-05 NuCare 15 g AT FDA listed
Triamcinolone Acetonide 1 mg/g 68462-0131-17 Glenmark 1 tube FDA listed
Triamcinolone Acetonide 1 mg/g 68788-7797-01 Preferred 1 tube AT FDA listed
Triamcinolone Acetonide 1 mg/g 68788-8350-01 Preferred 1 tube AT FDA listed
Triamcinolone Acetonide 1 mg/g 68788-8356-00 Preferred 1 tube AT FDA listed
Triamcinolone Acetonide 1 mg/g 68788-8753-01 Preferred 1 tube AT FDA listed
Triamcinolone Acetonide 1 mg/g 70518-1524-00 REMEDYREPACK 15 g AT FDA listed
Triamcinolone Acetonide 1 mg/g 70518-2285-00 REMEDYREPACK 1 tube AT FDA listed
Triamcinolone Acetonide 1 mg/g 70518-2403-00 REMEDYREPACK 1 tube AT FDA listed
Triamcinolone Acetonide 1 mg/g 70518-2963-00 REMEDYREPACK 1 tube AT Discontinued
Triamcinolone Acetonide 1 mg/g 70518-4527-00 REMEDYREPACK 1 tube AT FDA listed
Triamcinolone Acetonide 1 mg/g 71205-0627-15 Proficient 1 tube AT FDA listed
Triamcinolone acetonide 1 mg/g 71335-2211-01 Bryant 454 g AT FDA listed
Triamcinolone Acetonide 1 mg/g 71335-2712-01 Bryant 454 g AT FDA listed
Triamcinolone Acetonide 1 mg/g 71335-2713-01 Bryant 80 g AT FDA listed
Triamcinolone Acetonide 1 mg/g 72162-1386-04 Bryant 1 tube AT FDA listed
Triamcinolone acetonide 1 mg/g 72162-1832-03 Bryant 30 g AT FDA listed
Triamcinolone Acetonide 1 mg/g 72189-0039-80 Direct_Rx 80 g AT FDA listed
Triamcinolone Acetonide 1 mg/g 72189-0277-15 Direct_Rx 15 g AT FDA listed
Triamcinolone Acetonide 1 mg/g 72189-0330-80 Direct 80 g AT FDA listed
Triamcinolone Acetonide 1 mg/g 72189-0571-80 Direct_rx 80 g AT FDA listed
Triamcinolone Acetonide 1 mg/g 72189-0670-30 Direct_rx 30 g AT FDA listed
Dermavyx 72835-0777-02 V2 1 kit FDA listed
Triamcinolone Acetonide 1 mg/g 76420-0203-15 Asclemed 1 tube AT FDA listed
Triamcinolone Acetonide 1 mg/g 76420-0348-00 Asclemed 454 g AT FDA listed
Triamcinolone Acetonide 1 mg/g 82804-0071-30 Proficient 1 tube AT FDA listed
Triamcinolone Acetonide 1 mg/g 82804-0145-30 Proficient 1 tube AT FDA listed
Triadermex 84460-0100-08 Florrax 1 kit FDA listed
Triamcinolone Acetonide 1 mg/g 50090-2244-00 A-S 1 tube AT FDA listed
Triamcinolone acetonide 1 mg/g 50090-6978-00 A-S 1 tube AT FDA listed
Triamcinolone Acetonide 1 mg/g 68462-0797-17 Glenmark 1 tube FDA listed
Triamcinolone Acetonide 1 mg/g 71205-0108-15 Proficient 1 tube AT FDA listed
Triamcinolone Acetonide 1 mg/g 68071-4286-05 NuCare 15 g FDA listed
Triamcinolone Acetonide 1 mg/g 50090-3508-00 A-S 1 tube AT FDA listed
Triamcinolone Acetonide 1 mg/g 68071-1872-08 NuCare 80 g AT FDA listed
Triamcinolone Acetonide 1 mg/g 70518-3689-00 REMEDYREPACK 1 tube AT FDA listed
Kourzeq 1 mg/g 82682-0001-05 MidAmerica 1 tube AT FDA listed
Triamcinolone Acetonide 1 mg/g 76420-0361-00 Asclemed 454 g AT FDA listed
Triamcinolone Acetonide 1 mg/g 82804-0079-30 Proficient 1 tube AT FDA listed
Triamcinolone Acetonide 1 mg/g 50090-4761-00 A-S 1 tube AT FDA listed
Triamcinolone Acetonide 1 mg/g 50090-7679-00 A-S 1 tube AT FDA listed
Triamcinolone Acetonide 1 mg/g 61919-0619-15 DIRECTRX 15 g AT FDA listed
Triamcinolone Acetonide 1 mg/g 72162-2336-02 Bryant 1 tube AT FDA listed
Triamcinolone Acetonide 1 mg/g 67296-1927-01 RedpharmDrug 1 tube AT FDA listed
Triamcinolone acetonide 1 mg/g 68071-2362-05 NuCare 1 tube AT FDA listed
Triamcinolone Acetonide 1 mg/g 68788-8386-05 Preferred 1 tube AT FDA listed
Triamcinolone Acetonide 1 mg/g 85766-0244-15 Sportpharm 1 tube AT FDA listed
Triamcinolone acetonide 1 mg/g 67296-2327-01 Redpharm 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

🏛️
2012
On the market since
Apr 2012
📍
2026
Currently FDA-listed
14 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.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Triamcinolone Acetonide — the program that covers self-administered drugs. 22 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 Triamcinolone Acetonide. 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
$17.79M
Claims incl. refills
1.7M
Beneficiaries
1.4M
Spend / beneficiary
$13.01
Spend / claim
$10.45
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 Triamcinolone Acetonide — the ingredient across all brands.

Top reported reactions

Pruritus2,650
Rash2,534
Pain2,232
Fatigue2,133
Nausea2,043
Headache1,916
Condition Aggravated1,747

Reporter sex

31,697 reports
Male · 34%
Female · 66%
Unknown · 0%

Serious outcomes

Hospitalization6,577
Death3,076
Disabling2,415
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4,201 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 Marketing startStatus
63629-8779-01 You're viewing this 30 g in 1 TUBE (63629-8779-1) 2021-08-31 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 63629-8779-1, 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: 63629-8779-01, written without dashes as 63629877901. 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 63629-8779-01, the first segment (63629) is the labeler code FDA assigned to Bryant Ranch Prepack; the middle segment (8779) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Bryant Ranch Prepack. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Bryant Ranch Prepack 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 20 words

INDICATIONS & USAGE Triamcinolone acetonide cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

⏱️ Dosage and Administration 59 words

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

Contraindications 22 words

CONTRAINDICATIONS Triamcinolone acetonide cream is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

🤒 Adverse Reactions 59 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 Miliaria

🤰 Pregnancy 92 words

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 not 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 115 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, Cushings'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 children 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 16 words

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

🧬 Clinical Pharmacology 192 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 systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteriods 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 39 words

HOW SUPPLIED Triamcinolone acetonide cream USP 0.1% is supplied in 30 g tube NDC: 63629-8779-1 Store at 20-25°C (68°-77°F) [see USP Controlled Room Temperature]. Avoid excessive heat. Protect from freezing. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

📋 Description 153 words

DESCRIPTION The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Triamcinolone acetonide is a member of this class. Chemically triamcinolone acetonide is pregna-1, 4-diene-3, 20-dione, 9-flouro-11, 21-dihydroxy-16, 17-[(1-methylethylidene)bis(oxy)]-(11β16a).

Its structural formula is: Each gram of Triamcinolone Acetonide Cream USP, 0.025 % contains 0.25 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate. Each gram of Triamcinolone Acetonide Cream USP, 0.1 % contains 1 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate.

Each gram of Triamcinolone Acetonide Cream USP, 0.5 % contains 5 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate.

💬 Information for Patients 121 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 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 ↗
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.