TRIAMCINOLONE ACETONIDE

Product NDC
61919-650
Requested package NDC
61919-650-15
11-digit product format
619190650
Labeler code
61919
Product ID
61919-650_4d3a81d3-8f47-ac04-e063-6394a90a545d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRIAMCINOLONE ACETONIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
DIRECTRX
Application
ANDA085692
Marketing category
ANDA
Marketing start
2019-03-05
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
A085692-001TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATRLD, RS, Approved before 1982
A085692-002TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATRLD, RS, Approved before 1982
A085692-003TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE0.1%CREAM / 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
A085692-001AT
A085692-002AT
A085692-003AT

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 UTC2026-02A085692-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085692-002TRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085692-003TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATRLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085692-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085692-002TRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085692-003TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATRLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A085692-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085692-002TRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085692-003TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATRLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085692-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085692-002TRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085692-003TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085692-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATRLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085692-002TRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATRLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085692-003TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085692-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATRLD, RS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085692-002TRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATRLD, RS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085692-003TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085692-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATRLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085692-002TRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATRLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085692-003TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085692-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATRLD, RS, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085692-002TRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATRLD, RS, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085692-003TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085692-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATRLD, RS, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085692-002TRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATRLD, RS, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085692-003TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATRLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A085692-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATRLD, RS, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A085692-002TRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATRLD, RS, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A085692-003TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATRLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085692-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATRLD, RS, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085692-002TRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATRLD, RS, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085692-003TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085692-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATRLD, RS, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085692-002TRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATRLD, RS, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085692-003TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085692-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATRLD, RS, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085692-002TRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATRLD, RS, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085692-003TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATRLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A085692-001TRIAMCINOLONE ACETONIDE0.025%CREAM / 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 UTC2026-02A085692-001AT1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085692-002AT1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085692-003AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085692-001AT131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085692-002AT131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085692-003AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A085692-001AT16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085692-002AT16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085692-003AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085692-001AT1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085692-002AT1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085692-003AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085692-001AT1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085692-002AT1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085692-003AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085692-001AT103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085692-002AT103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085692-003AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085692-001AT12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085692-002AT12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085692-003AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085692-001AT15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085692-002AT15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085692-003AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085692-001AT1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085692-002AT1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085692-003AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A085692-001AT1d06236e962d9…
2024-10-29 15:01 UTC2024-10A085692-002AT1d06236e962d9…
2024-10-29 15:01 UTC2024-10A085692-003AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085692-001AT179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085692-002AT179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085692-003AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085692-001AT1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085692-002AT1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085692-003AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085692-001AT11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085692-002AT11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085692-003AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A085692-001AT18072bd15b7f6…

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1014314Internal RxNorm lookup
1085636Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
835bbcd1-3869-646c-e053-2a91aa0a796aAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-650-152025-01-30C16284748780-12cef2736-7d1c-d83d-e063-dadaa90ab31fTRIAMCINOLONE ACETONIDE 0.1% 15g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-650-15TRIAMCINOLONE ACETONIDE15 g in 1 TUBECREAM153

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-650-15GM - Gram61919-6507a37d2f2-dbfe-4213-8413-90c666ebc60a12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-650TRIAMCINOLONE ACETONIDE CREAM TRIAMCINOLONE ACETONIDE OINTMENT [DIRECTRX]2Current NDC, Legacy NDC, 1 package rows20210205_835bbcd1-3869-646c-e053-2a91aa0a796a.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEDIRECTRX835bbcd1-3869-646c-e053-2a91aa0a796a2026-03-17Adverse reactionsExact identifier
application applno (ANDA): 085692
application number: ANDA085692
ndc (package): 61919-650-15
ndc (product): 61919-650
ndc11 (package): 61919065015
triamcinolone acetonideTRIAMCINOLONE ACETONIDEE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC92a1ded0-8e1a-4994-9c8a-89e84fc85c942026-01-28Adverse reactionsExact identifier
application applno (ANDA): 085692
application number: ANDA085692
triamcinolone acetonideTRIAMCINOLONE ACETONIDEPreferred Pharmaceuticals Inc.5701a07f-bd22-4bc7-95ff-0c5444ea59712025-10-01Adverse reactionsExact identifier
application applno (ANDA): 085692
application number: ANDA085692
triamcinolone acetonideTRIAMCINOLONE ACETONIDEPreferred Pharmaceuticals Inc.5040eba2-2d00-496a-8773-66ba5440610f2025-06-27Adverse reactionsExact identifier
application applno (ANDA): 085692
application number: ANDA085692
triamcinolone acetonideTRIAMCINOLONE ACETONIDEA-S Medication Solutions2d6b9c2f-f1a0-413e-b333-64da523682022023-12-09Adverse reactionsExact identifier
application applno (ANDA): 085692
application number: ANDA085692
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEProficient Rx LP41c1fe93-0509-4cf6-ac35-049028b731de2019-12-01Adverse reactionsExact identifier
application applno (ANDA): 085692
application number: ANDA085692

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014314triamcinolone acetonide 0.1 % Topical CreamPSN835bbcd1-3869-646c-e053-2a91aa0a796a3
1085636triamcinolone acetonide 0.1 % Topical OintmentPSN835bbcd1-3869-646c-e053-2a91aa0a796a3
1085636triamcinolone acetonide 0.001 MG/MG Topical OintmentSCD835bbcd1-3869-646c-e053-2a91aa0a796a3
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCD835bbcd1-3869-646c-e053-2a91aa0a796a3
1014314triamcinolone acetonide 0.1 % Topical CreamSY835bbcd1-3869-646c-e053-2a91aa0a796a3
1085636triamcinolone acetonide 0.1 % Topical OintmentSY835bbcd1-3869-646c-e053-2a91aa0a796a3
1014314triamcinolone acetonide 1 MG per GM Topical CreamSY835bbcd1-3869-646c-e053-2a91aa0a796a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-650-156191906501515 g in 1 TUBE (61919-650-15) 15 g2019-03-050000-00-00NoNoCurrent