FDA.reportPublic FDA data

Triamcinolone Acetonide

Product NDC
51672-1284
11-digit product format
516721284
Labeler code
51672
Product ID
51672-1284_3908d687-a30a-2f2a-e063-6394a90a6f82
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamcinolone Acetonide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA040037
Marketing category
ANDA
Marketing start
1994-09-30
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
Rxcui1085636

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
51672-1284-1Triamcinolone Acetonide1 in 1 CARTONOINTMENT16
51672-1284-1Triamcinolone Acetonide15 g in 1 TUBEOINTMENT156
51672-1284-2Triamcinolone Acetonide30 g in 1 TUBEOINTMENT306
51672-1284-2Triamcinolone Acetonide1 in 1 CARTONOINTMENT16
51672-1284-8Triamcinolone Acetonide80 g in 1 TUBEOINTMENT806
51672-1284-8Triamcinolone Acetonide1 in 1 CARTONOINTMENT16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1284-1GM - Gram51672-1284b27f14ad-ee7a-45b1-805a-46429d9604f012013-02-13
51672-1284-2GM - Gram51672-1284a87592bc-7076-4dca-8391-cf772076639a12016-09-02
51672-1284-8GM - Gram51672-1284f682a100-a1fa-4e62-881b-415731d06fc912013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Triamcinolone AcetonideACTIVE INGREDIENTF446C597KATRIAMCINOLONE ACETONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]1
Triamcinolone AcetonideACTIVE MOIETYF446C597KATRIAMCINOLONE ACETONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]1
medium-chain triglyceridesINACTIVE INGREDIENTC9H2L21V7UTRIAMCINOLONE ACETONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TTRIAMCINOLONE ACETONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UTRIAMCINOLONE ACETONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHTRIAMCINOLONE ACETONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1284TRIAMCINOLONE ACETONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]5Current NDC, Legacy NDC, 6 package rows20161229_6b4a9a08-f436-4f33-a940-a97c727788f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1085636triamcinolone acetonide 0.1 % Topical OintmentPSNc21c3a96-d491-4a60-a09e-d0eccd34b20f7
1085636triamcinolone acetonide 0.001 MG/MG Topical OintmentSCDc21c3a96-d491-4a60-a09e-d0eccd34b20f7
1085636triamcinolone acetonide 0.1 % Topical OintmentSYc21c3a96-d491-4a60-a09e-d0eccd34b20f7
1085636triamcinolone acetonide 0.1 % Topical OintmentPSN6b4a9a08-f436-4f33-a940-a97c727788f96
1085636triamcinolone acetonide 0.001 MG/MG Topical OintmentSCD6b4a9a08-f436-4f33-a940-a97c727788f96
1085636triamcinolone acetonide 0.1 % Topical OintmentSY6b4a9a08-f436-4f33-a940-a97c727788f96
1085636triamcinolone acetonide 0.1 % Topical OintmentPSN1cfbb8cd-94c5-b1eb-e063-6394a90ade171
1085636triamcinolone acetonide 0.1 % Topical OintmentPSN64d6a2f3-18cc-4ce4-8e75-4d77515e19111
1085636triamcinolone acetonide 0.1 % Topical OintmentPSNe07af497-c7d6-09cf-e053-2a95a90a49251
1085636triamcinolone acetonide 0.001 MG/MG Topical OintmentSCD1cfbb8cd-94c5-b1eb-e063-6394a90ade171
1085636triamcinolone acetonide 0.001 MG/MG Topical OintmentSCD64d6a2f3-18cc-4ce4-8e75-4d77515e19111
1085636triamcinolone acetonide 0.001 MG/MG Topical OintmentSCDe07af497-c7d6-09cf-e053-2a95a90a49251
1085636triamcinolone acetonide 0.1 % Topical OintmentSY1cfbb8cd-94c5-b1eb-e063-6394a90ade171
1085636triamcinolone acetonide 0.1 % Topical OintmentSY64d6a2f3-18cc-4ce4-8e75-4d77515e19111
1085636triamcinolone acetonide 0.1 % Topical OintmentSYe07af497-c7d6-09cf-e053-2a95a90a49251

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1284-1516721284011 TUBE in 1 CARTON (51672-1284-1) / 15 g in 1 TUBE1 tube1994-09-300000-00-00NoNoCurrent
51672-1284-2516721284021 TUBE in 1 CARTON (51672-1284-2) / 30 g in 1 TUBE1 tube2016-10-260000-00-00NoNoCurrent
51672-1284-8516721284081 TUBE in 1 CARTON (51672-1284-8) / 80 g in 1 TUBE1 tube1994-09-300000-00-00NoNoCurrent