triamcinolone acetonide

Product NDC
71205-124
11-digit product format
712050124
Labeler code
71205
Product ID
71205-124_13975027-13af-4ff6-96fe-2c73d24b50a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
triamcinolone acetonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Proficient Rx LP
Application
ANDA208848
Marketing category
ANDA
Marketing start
2017-04-17
Marketing end
0000-00-00
Substance
TRIAMCINOLONE ACETONIDE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71205-124DDiscontinued by firm2026-08-03
excluded packagepackage71205-12471205-124-15DDiscontinued by firm2026-08-03
excluded packagepackage71205-12471205-124-80DDiscontinued by firm2026-08-03

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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71205-124-15d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71205-124-80d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71205-124-15f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71205-124-80f5e01cc5f278…a2eaf40c39c3…

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208848-001TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT2017-09-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208848-001AT

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A208848-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT2017-09-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208848-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT2017-09-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A208848-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT2017-09-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208848-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT2017-09-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208848-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT2017-09-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208848-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT2017-09-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208848-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT2017-09-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208848-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT2017-09-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208848-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT2017-09-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208848-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT2017-09-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208848-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT2017-09-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208848-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT2017-09-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208848-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT2017-09-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208848-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT2017-09-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208848-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT2017-09-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208848-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT2017-09-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208848-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT2017-09-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208848-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT2017-09-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208848-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT2017-09-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208848-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT2017-09-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208848-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT2017-09-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A208848-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT2017-09-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208848-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT2017-09-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208848-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT2017-09-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208848-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT2017-09-183f01610625f2…
2019-09-15 20:21 UTC2019-09A208848-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT2017-09-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A208848-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT2017-09-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208848-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT2017-09-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208848-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT2017-09-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208848-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT2017-09-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208848-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT2017-09-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208848-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT2017-09-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208848-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT2017-09-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208848-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT2017-09-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A208848-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT2017-09-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A208848-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT2017-09-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208848-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT2017-09-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208848-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT2017-09-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208848-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT2017-09-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208848-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT2017-09-18cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A208848-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208848-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208848-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208848-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208848-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208848-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208848-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208848-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208848-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208848-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208848-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208848-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208848-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208848-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208848-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208848-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208848-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208848-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208848-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208848-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208848-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A208848-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208848-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208848-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208848-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A208848-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A208848-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208848-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208848-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208848-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208848-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208848-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208848-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208848-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A208848-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A208848-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208848-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208848-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208848-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208848-001AT1cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-124-15GM - Gram71205-1241afcfd94-62a2-421f-8fb1-d5b5b745c92912020-01-03
71205-124-80GM - Gram71205-1241fc144f7-7476-4b9c-b5e8-bdcad99a7e5612018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-124TRIAMCINOLONE ACETONIDE CREAM [PROFICIENT RX LP]3Legacy NDC20191115_1d093440-d6fa-416b-888d-1846c95fb1b1.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEEncube Ethicals, Inc.db87426f-124c-4ea9-bb15-fc3a0da10a4e2026-07-07Adverse reactionsExact identifier
application applno (ANDA): 208848
application number: ANDA208848
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEDirect_rx4e400049-c763-56f7-e063-6294a90a6fd72026-03-30Adverse reactionsExact identifier
application applno (ANDA): 208848
application number: ANDA208848
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEPreferred Pharmaceuticals Inc.60973042-077c-4265-988c-ad381f5603332026-01-19Adverse reactionsExact identifier
application applno (ANDA): 208848
application number: ANDA208848
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEREMEDYREPACK INC.abad7215-95d2-4171-95cf-fa768081fd3b2025-12-03Adverse reactionsExact identifier
application applno (ANDA): 208848
application number: ANDA208848
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEProficient Rx LPc6e46d6f-c64d-4242-a56f-8aff96e689932024-10-01Adverse reactionsExact identifier
application applno (ANDA): 208848
application number: ANDA208848
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDENuCare Pharmaceuticals, Inc.200bb913-a6ac-5a6b-e063-6294a90a161a2024-08-19Adverse reactionsExact identifier
application applno (ANDA): 208848
application number: ANDA208848
triamcinolone acetonideTRIAMCINOLONE ACETONIDENuCare Pharmaceuticals,Inc.69aec845-3d4a-d226-e053-2991aa0afd122024-06-10Adverse reactionsExact identifier
application applno (ANDA): 208848
application number: ANDA208848

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-124-15712050124151 TUBE in 1 CARTON (71205-124-15) > 15 g in 1 TUBE1 tube2019-11-010000-00-00NoNoCurrent
71205-124-80712050124801 TUBE in 1 CARTON (71205-124-80) > 80 g in 1 TUBE1 tube2018-10-010000-00-00NoNoCurrent