Triamcinolone Acetonide

Product NDC
63187-495
11-digit product format
631870495
Labeler code
63187
Product ID
63187-495_51c4bdf0-43a4-4007-b86c-85eb22ad017e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamcinolone Acetonide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Proficient Rx LP
Application
ANDA087385
Marketing category
ANDA
Marketing start
2006-11-10
Substance
TRIAMCINOLONE ACETONIDE
Active strength
5 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A087385-001TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALATRLD, RS, Approved before 1982
A087385-002TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE0.025%OINTMENT / TOPICALATRLD, RS, Approved before 1982
A087385-003TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALATRLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A087385-001AT
A087385-002AT
A087385-003AT

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A087385-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALATRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A087385-002TRIAMCINOLONE ACETONIDE0.025%OINTMENT / TOPICALATRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A087385-003TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALATRLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A087385-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALATRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A087385-002TRIAMCINOLONE ACETONIDE0.025%OINTMENT / TOPICALATRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A087385-003TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALATRLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A087385-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALATRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A087385-002TRIAMCINOLONE ACETONIDE0.025%OINTMENT / TOPICALATRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A087385-003TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALATRLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A087385-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALATRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A087385-002TRIAMCINOLONE ACETONIDE0.025%OINTMENT / TOPICALATRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A087385-003TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALATRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087385-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALATRLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087385-002TRIAMCINOLONE ACETONIDE0.025%OINTMENT / TOPICALATRLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087385-003TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALATRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087385-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALATRLD, RS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087385-002TRIAMCINOLONE ACETONIDE0.025%OINTMENT / TOPICALATRLD, RS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087385-003TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALATRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087385-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALATRLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087385-002TRIAMCINOLONE ACETONIDE0.025%OINTMENT / TOPICALATRLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087385-003TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALATRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087385-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALATRLD, RS, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087385-002TRIAMCINOLONE ACETONIDE0.025%OINTMENT / TOPICALATRLD, RS, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087385-003TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALATRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087385-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALATRLD, RS, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087385-002TRIAMCINOLONE ACETONIDE0.025%OINTMENT / TOPICALATRLD, RS, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087385-003TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALATRLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A087385-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALATRLD, RS, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A087385-002TRIAMCINOLONE ACETONIDE0.025%OINTMENT / TOPICALATRLD, RS, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A087385-003TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALATRLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087385-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALATRLD, RS, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087385-002TRIAMCINOLONE ACETONIDE0.025%OINTMENT / TOPICALATRLD, RS, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087385-003TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALATRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087385-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALATRLD, RS, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087385-002TRIAMCINOLONE ACETONIDE0.025%OINTMENT / TOPICALATRLD, RS, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087385-003TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALATRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087385-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALATRLD, RS, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087385-002TRIAMCINOLONE ACETONIDE0.025%OINTMENT / TOPICALATRLD, RS, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087385-003TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALATRLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A087385-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALATRLD, RS, Approved before 19828072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A087385-001AT1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A087385-002AT1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A087385-003AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A087385-001AT131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A087385-002AT131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A087385-003AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A087385-001AT16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A087385-002AT16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A087385-003AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A087385-001AT1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A087385-002AT1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A087385-003AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087385-001AT1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087385-002AT1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087385-003AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087385-001AT103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087385-002AT103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087385-003AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087385-001AT12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087385-002AT12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087385-003AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087385-001AT15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087385-002AT15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087385-003AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087385-001AT1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087385-002AT1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087385-003AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A087385-001AT1d06236e962d9…
2024-10-29 15:01 UTC2024-10A087385-002AT1d06236e962d9…
2024-10-29 15:01 UTC2024-10A087385-003AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087385-001AT179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087385-002AT179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087385-003AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087385-001AT1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087385-002AT1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087385-003AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087385-001AT11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087385-002AT11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087385-003AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A087385-001AT18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIAMCINOLONE ACETONIDE5 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
1085640Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
63b51d50-7eb9-4687-965c-d4c57afc4030Available 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
63187-495-15Triamcinolone Acetonide1 in 1 CARTONOINTMENT15
63187-495-15Triamcinolone Acetonide15 g in 1 TUBEOINTMENT155

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRIAMCINOLONE ACETONIDEACTIVE INGREDIENTF446C597KATRIAMCINOLONE ACETONIDE OINTMENT [PROFICIENT RX LP]1
TRIAMCINOLONE ACETONIDEACTIVE MOIETYF446C597KATRIAMCINOLONE ACETONIDE OINTMENT [PROFICIENT RX LP]1
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPTRIAMCINOLONE ACETONIDE OINTMENT [PROFICIENT RX LP]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UTRIAMCINOLONE ACETONIDE OINTMENT [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-495TRIAMCINOLONE ACETONIDE OINTMENT [PROFICIENT RX LP]5Current NDC, Legacy NDC, 2 package rows20220505_63b51d50-7eb9-4687-965c-d4c57afc4030.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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEA-S Medication Solutions6d565a2c-d145-425a-a87d-6d07a90ad2fe2026-04-27Adverse reactionsExact identifier
application applno (ANDA): 087385
application number: ANDA087385
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEREMEDYREPACK INC.809c8ef7-6313-412e-82c7-adaa824bb5992026-04-15Adverse reactionsExact identifier
application applno (ANDA): 087385
application number: ANDA087385
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEDIRECTRX835bbcd1-3869-646c-e053-2a91aa0a796a2026-03-17Adverse reactionsExact identifier
application applno (ANDA): 087385
application number: ANDA087385
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEA-S Medication Solutionsfab09252-d474-4894-bbbf-a95b14c789362025-11-26Adverse reactionsExact identifier
application applno (ANDA): 087385
application number: ANDA087385
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDENuCare Pharmaceuticals,Inc.a4d74513-0548-4f11-e053-2995a90a18302024-12-13Adverse reactionsExact identifier
application applno (ANDA): 087385
application number: ANDA087385
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEBryant Ranch Prepackc29de67c-c4c7-412b-ae5f-b5562a95a8f92024-11-20Adverse reactionsExact identifier
application applno (ANDA): 087385
application number: ANDA087385
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEBryant Ranch Prepack658a80d1-1cd2-45a4-b097-6605c1ba31cd2024-06-18Adverse reactionsExact identifier
application applno (ANDA): 087385
application number: ANDA087385
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEA-S Medication Solutionsc3b09e80-67a7-4c5f-b324-2d8ecc9c054e2024-05-17Adverse reactionsExact identifier
application applno (ANDA): 087385
application number: ANDA087385
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEProficient Rx LP1bc85267-249f-4c55-9a8a-06d265263cb52023-12-01Adverse reactionsExact identifier
application applno (ANDA): 087385
application number: ANDA087385
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEPadagis Israel Pharmaceuticals Ltd838ba2fa-5133-4975-bd99-791891a144c52023-10-01Adverse reactionsExact identifier
application applno (ANDA): 087385
application number: ANDA087385
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEProficient Rx LP63b51d50-7eb9-4687-965c-d4c57afc40302022-04-01Adverse reactionsExact identifier
application applno (ANDA): 087385
application number: ANDA087385
ndc (product): 63187-495

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1085640triamcinolone acetonide 0.5 % Topical OintmentPSN63b51d50-7eb9-4687-965c-d4c57afc40305
1085640triamcinolone acetonide 0.005 MG/MG Topical OintmentSCD63b51d50-7eb9-4687-965c-d4c57afc40305
1085640triamcinolone acetonide 0.5 % Topical OintmentSY63b51d50-7eb9-4687-965c-d4c57afc40305

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-495-15631870495151 TUBE in 1 CARTON (63187-495-15) / 15 g in 1 TUBE1 tube2015-02-020000-00-00NoNoCurrent