FDA.reportPublic FDA data

Triamcinolone acetonide

Product NDC
16714-276
11-digit product format
167140276
Labeler code
16714
Product ID
16714-276_0ac8f7cc-71c3-4cf1-b599-ae76c7b7a423
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamcinolone acetonide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
NorthStar RxLLC
Application
ANDA209828
Marketing category
ANDA
Marketing start
2025-04-02
Substance
TRIAMCINOLONE ACETONIDE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Triamcinolone acetonide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIAMCINOLONE ACETONIDE1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF446C597KA
Rxcui1085633, 1085636, 1085640

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
16714-276-01Triamcinolone acetonide1 in 1 CARTONOINTMENT13
16714-276-01Triamcinolone acetonide15 g in 1 TUBEOINTMENT153
16714-276-02Triamcinolone acetonide80 g in 1 TUBEOINTMENT803
16714-276-02Triamcinolone acetonide1 in 1 CARTONOINTMENT13
16714-276-03Triamcinolone acetonide454 g in 1 JAROINTMENT4543

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-276-01GM - Gram16714-27623d08419-fb64-4667-8c96-557432a4efd712025-05-14
16714-276-02GM - Gram16714-2760763b8cd-f39a-4f54-a032-3a0dd111958312025-05-14
16714-276-03GM - Gram16714-2764864dcbd-9f78-4cc1-a85f-2b4a7b4a36f112025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-276TRIAMCINOLONE ACETONIDE OINTMENT [NORTHSTAR RXLLC]3Current NDC, 5 package rows20250406_3379f247-4a29-4373-9843-0b7f044c2276.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1085633triamcinolone acetonide 0.025 % Topical OintmentPSN3379f247-4a29-4373-9843-0b7f044c22763
1085636triamcinolone acetonide 0.1 % Topical OintmentPSN3379f247-4a29-4373-9843-0b7f044c22763
1085640triamcinolone acetonide 0.5 % Topical OintmentPSN3379f247-4a29-4373-9843-0b7f044c22763
1085633triamcinolone acetonide 0.00025 MG/MG Topical OintmentSCD3379f247-4a29-4373-9843-0b7f044c22763
1085636triamcinolone acetonide 0.001 MG/MG Topical OintmentSCD3379f247-4a29-4373-9843-0b7f044c22763
1085640triamcinolone acetonide 0.005 MG/MG Topical OintmentSCD3379f247-4a29-4373-9843-0b7f044c22763
1085633triamcinolone acetonide 0.025 % Topical OintmentSY3379f247-4a29-4373-9843-0b7f044c22763
1085636triamcinolone acetonide 0.1 % Topical OintmentSY3379f247-4a29-4373-9843-0b7f044c22763
1085640triamcinolone acetonide 0.5 % Topical OintmentSY3379f247-4a29-4373-9843-0b7f044c22763

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
16714-276-01167140276011 TUBE in 1 CARTON (16714-276-01) / 15 g in 1 TUBE1 tube2025-04-02NoNoCurrent
16714-276-02167140276021 TUBE in 1 CARTON (16714-276-02) / 80 g in 1 TUBE1 tube2025-04-02NoNoCurrent
16714-276-0316714027603454 g in 1 JAR (16714-276-03) 454 g2025-04-02NoNoCurrent