Triamcinolone Acetonide

Product NDC
68071-4397
Requested package NDC
68071-4397-5
11-digit product format
680714397
Labeler code
68071
Product ID
68071-4397_1a8b5731-59a1-8a75-e063-6394a90a28a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamcinolone Acetonide
Dosage form
CREAM
Route
TOPICAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA086413
Marketing category
ANDA
Marketing start
2006-05-17
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

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68071-439768071-4397-5IInactivated by FDAexcluded / ndc_excluded.zip8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68071-439768071-4397-5IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68071-439768071-4397-5IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

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
A086413-001TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATApproved before 1982
A086413-002TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATApproved before 1982
A086413-003TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATApproved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A086413-001AT
A086413-002AT
A086413-003AT

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 UTC2026-02A086413-001TRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A086413-002TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A086413-003TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A086413-001TRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A086413-002TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A086413-003TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A086413-001TRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A086413-002TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A086413-003TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A086413-001TRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A086413-002TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A086413-003TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A086413-001TRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A086413-002TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A086413-003TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A086413-001TRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A086413-002TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A086413-003TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A086413-001TRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A086413-002TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A086413-003TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A086413-001TRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A086413-002TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A086413-003TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A086413-001TRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A086413-002TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A086413-003TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A086413-001TRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A086413-002TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A086413-003TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A086413-001TRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A086413-002TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A086413-003TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A086413-001TRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A086413-002TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A086413-003TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A086413-001TRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A086413-002TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A086413-003TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A086413-001TRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATApproved 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 UTC2026-02A086413-001AT1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A086413-002AT1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A086413-003AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A086413-001AT131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A086413-002AT131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A086413-003AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A086413-001AT16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A086413-002AT16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A086413-003AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A086413-001AT1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A086413-002AT1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A086413-003AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A086413-001AT1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A086413-002AT1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A086413-003AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A086413-001AT103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A086413-002AT103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A086413-003AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A086413-001AT12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A086413-002AT12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A086413-003AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A086413-001AT15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A086413-002AT15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A086413-003AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A086413-001AT1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A086413-002AT1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A086413-003AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A086413-001AT1d06236e962d9…
2024-10-29 15:01 UTC2024-10A086413-002AT1d06236e962d9…
2024-10-29 15:01 UTC2024-10A086413-003AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A086413-001AT179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A086413-002AT179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A086413-003AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A086413-001AT1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A086413-002AT1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A086413-003AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A086413-001AT11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A086413-002AT11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A086413-003AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A086413-001AT18072bd15b7f6…

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
1085686Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6a282425-8fdc-1fca-e053-2a91aa0a1c3aAvailable 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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4397-5Triamcinolone Acetonide15 g in 1 BOXCREAM155

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4397TRIAMCINOLONE ACETONIDE CREAM [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 1 package rows20240612_6a282425-8fdc-1fca-e053-2a91aa0a1c3a.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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEREMEDYREPACK INC.484766b9-cec6-4379-b79d-398c921b32b22026-05-18Adverse reactionsExact identifier
application applno (ANDA): 086413
application number: ANDA086413
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEBryant Ranch Prepack0844a8f0-116d-40f6-8462-cccd6bcefc8a2026-03-27Adverse reactionsExact identifier
application applno (ANDA): 086413
application number: ANDA086413
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEREMEDYREPACK INC.c76d68dc-78e6-407c-ba9d-5d1c5d13509e2026-02-05Adverse reactionsExact identifier
application applno (ANDA): 086413
application number: ANDA086413
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEA-S Medication Solutionsda474ee7-ac67-4e62-991d-ca979f13dea22025-05-15Adverse reactionsExact identifier
application applno (ANDA): 086413
application number: ANDA086413
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE CREAMDirect Rxd92e9eaf-3a79-76d7-e053-2995a90ae28d2025-01-21Adverse reactionsExact identifier
application applno (ANDA): 086413
application number: ANDA086413
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEPreferred Pharmaceuticals Incdf6f5944-ba12-4731-9749-9095b3570dd32025-01-16Adverse reactionsExact identifier
application applno (ANDA): 086413
application number: ANDA086413
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEPadagis Israel Pharmaceuticals Ltd5d2fe6c2-3856-47f6-843f-077b2e1080a02024-12-31Adverse reactionsExact identifier
application applno (ANDA): 086413
application number: ANDA086413
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEBryant Ranch Prepack69786597-99f9-4bdc-91bc-c50e5fd682c82024-06-26Adverse reactionsExact identifier
application applno (ANDA): 086413
application number: ANDA086413
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDENuCare Pharmaceuticals,Inc.6a282425-8fdc-1fca-e053-2a91aa0a1c3a2024-06-10Adverse reactionsExact identifier
application applno (ANDA): 086413
application number: ANDA086413
ndc (package): 68071-4397-5
ndc (product): 68071-4397
ndc11 (package): 68071439705
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEBryant Ranch Prepack2229a9e5-144f-42be-ab12-9c4f4163d22a2024-03-12Adverse reactionsExact identifier
application applno (ANDA): 086413
application number: ANDA086413
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEBryant Ranch Prepack1e9007e8-fcd4-4aff-8d0a-4a43e0b8e6732024-01-12Adverse reactionsExact identifier
application applno (ANDA): 086413
application number: ANDA086413
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEBryant Ranch Prepack2adb56d4-2883-4060-b8cb-65a7662cfdda2024-01-12Adverse reactionsExact identifier
application applno (ANDA): 086413
application number: ANDA086413
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEBryant Ranch Prepack72038652-b15a-4a84-bccc-d50731ac5f032023-11-01Adverse reactionsExact identifier
application applno (ANDA): 086413
application number: ANDA086413

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1085686triamcinolone acetonide 0.5 % Topical CreamPSN6a282425-8fdc-1fca-e053-2a91aa0a1c3a5
1085686triamcinolone acetonide 5 MG/ML Topical CreamSCD6a282425-8fdc-1fca-e053-2a91aa0a1c3a5
1085686triamcinolone acetonide 0.5 % Topical CreamSY6a282425-8fdc-1fca-e053-2a91aa0a1c3a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4397-56807143970515 g in 1 BOX (68071-4397-5) 15 g2018-04-180000-00-00NoNoCurrent