FDA.reportPublic FDA data

Triamcinolone Acetonide

Product NDC
63187-870
Requested package NDC
63187-870-15
11-digit product format
631870870
Labeler code
63187
Product ID
63187-870_bac15676-050f-4656-9a21-69342aa8c408
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamcinolone Acetonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Proficient Rx LP
Application
ANDA086414
Marketing category
ANDA
Marketing start
2006-09-28
Substance
TRIAMCINOLONE ACETONIDE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Triamcinolone Acetonide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIAMCINOLONE ACETONIDE1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F446C597KAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1014314Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4aa792cc-7cd4-4a98-8730-fa36feaa9b7aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d4d7da1a-7fd4-628e-cdae-89e749b1c534Product name720260127
75f7e47b-8736-a182-fc44-22aca8d79689Product name220251211
62986c8d-91f1-b1ba-b5a3-8b54b75bb8c2Product name620250516
e42f429b-c4e5-0402-e1c5-730154df4060Product name420240205
38d4de13-64b3-4057-b91c-4b5126962341Product name120220516
089e0644-1ea8-8654-4113-39f960dd57d5Product name320210115
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
5331c9c8-f64b-11e6-ccf1-071c477fcb0bProduct name720190612
9f64e0dc-109c-9660-8e0e-91ec987b3817Product name620171204
dfa879a3-32de-49f0-a7ba-9b9c3e13002fProduct name120171204
8de20f81-8411-4cf1-a8b2-03404ee56d01Product name320171109
a5f1a68c-0352-4f34-46a3-9b4eed239ed8Product name220160819
355b2224-0895-7135-83f5-d099a6a82a0aProduct name120140508
55be6b50-8cc0-f0f1-74a1-3416a91193aaProduct name120140508
7a0092d1-1e8c-0d78-4f8d-d95fa15cc3cfProduct name120140508
89b93c13-4be8-69f3-b33b-63e64feffb9bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-870-15Triamcinolone Acetonide15 g in 1 TUBECREAM156
63187-870-15Triamcinolone Acetonide1 in 1 CARTONCREAM16
63187-870-80Triamcinolone Acetonide80 g in 1 TUBECREAM806
63187-870-80Triamcinolone Acetonide1 in 1 CARTONCREAM16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-870-15GM - Gram63187-8700166c24a-33a5-4784-b204-0766d790918612018-06-11
63187-870-80GM - Gram63187-870386e940e-2a1e-4ca2-ba00-093eddbd55e912017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-870TRIAMCINOLONE ACETONIDE CREAM [PROFICIENT RX LP]6Current NDC, Legacy NDC, 4 package rows20230228_4aa792cc-7cd4-4a98-8730-fa36feaa9b7a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDENuCare Pharmaceuticals,Inc.5439cd3c-da8d-3b96-e054-00144ff8d46c2026-01-21Adverse reactionsExact identifier
application applno (ANDA): 086414
application number: ANDA086414
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDENuCare Pharmaceuticals,Inc.696cd64f-28dd-3dae-e053-2a91aa0a0c762025-02-13Adverse reactionsExact identifier
application applno (ANDA): 086414
application number: ANDA086414
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEProficient Rx LP4aa792cc-7cd4-4a98-8730-fa36feaa9b7a2023-02-01Adverse reactionsExact identifier
application applno (ANDA): 086414
application number: ANDA086414
ndc (package): 63187-870-15
ndc (product): 63187-870
ndc11 (package): 63187087015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014314triamcinolone acetonide 0.1 % Topical CreamPSN4aa792cc-7cd4-4a98-8730-fa36feaa9b7a6
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCD4aa792cc-7cd4-4a98-8730-fa36feaa9b7a6
1014314triamcinolone acetonide 0.1 % Topical CreamSY4aa792cc-7cd4-4a98-8730-fa36feaa9b7a6
1014314triamcinolone acetonide 1 MG per GM Topical CreamSY4aa792cc-7cd4-4a98-8730-fa36feaa9b7a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-870-15631870870151 TUBE in 1 CARTON (63187-870-15) / 15 g in 1 TUBE1 tube2017-07-030000-00-00NoNoCurrent