TRIAMCINOLONE ACETONIDE

Product NDC
21922-062
Requested package NDC
21922-062-30
11-digit product format
219220062
Labeler code
21922
Product ID
21922-062_7b796fae-0c7d-4fb6-9141-f4b52db5c85b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
triamcinolone acetonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Encube Ethicals, Inc.
Application
ANDA208848
Marketing category
ANDA
Marketing start
2024-03-16
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

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…

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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
db87426f-124c-4ea9-bb15-fc3a0da10a4eAvailable 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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
5331c9c8-f64b-11e6-ccf1-071c477fcb0bProduct name720190612
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
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
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
7a0092d1-1e8c-0d78-4f8d-d95fa15cc3cfProduct name120140508
89b93c13-4be8-69f3-b33b-63e64feffb9bProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21922-062-04TRIAMCINOLONE ACETONIDE15 g in 1 TUBECREAM153
21922-062-04TRIAMCINOLONE ACETONIDE1 in 1 CARTONCREAM13
21922-062-05TRIAMCINOLONE ACETONIDE30 g in 1 TUBECREAM303
21922-062-05TRIAMCINOLONE ACETONIDE1 in 1 CARTONCREAM13
21922-062-15TRIAMCINOLONE ACETONIDE1 in 1 CARTONCREAM13
21922-062-15TRIAMCINOLONE ACETONIDE80 g in 1 TUBECREAM803
21922-062-30TRIAMCINOLONE ACETONIDE454 g in 1 JARCREAM4543

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21922-062-04GM - Gram21922-0620ba7910c-f05a-451e-8d51-0809eb99222e12024-04-05
21922-062-05GM - Gram21922-062ea581114-855e-4609-b594-16581ea1feb912024-04-05
21922-062-15GM - Gram21922-06241f5e86d-e3e0-44e8-aafb-0f403dbab76912024-04-05
21922-062-30GM - Gram21922-062b2e87f67-184d-4e38-a893-f60e1193159812024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21922-062TRIAMCINOLONE ACETONIDE CREAM [ENCUBE ETHICALS PRIVATE LIMITED]1Current NDC, 7 package rows20240320_db87426f-124c-4ea9-bb15-fc3a0da10a4e.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
ndc (package): 21922-062-30
ndc (product): 21922-062
ndc11 (package): 21922006230
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014314triamcinolone acetonide 0.1 % Topical CreamPSNdb87426f-124c-4ea9-bb15-fc3a0da10a4e3
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCDdb87426f-124c-4ea9-bb15-fc3a0da10a4e3
1014314triamcinolone acetonide 0.1 % Topical CreamSYdb87426f-124c-4ea9-bb15-fc3a0da10a4e3
1014314triamcinolone acetonide 1 MG per GM Topical CreamSYdb87426f-124c-4ea9-bb15-fc3a0da10a4e3
1014314triamcinolone acetonide 0.1 % Topical CreamPSN60973042-077c-4265-988c-ad381f5603332
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCD60973042-077c-4265-988c-ad381f5603332
1014314triamcinolone acetonide 0.1 % Topical CreamSY60973042-077c-4265-988c-ad381f5603332
1014314triamcinolone acetonide 1 MG per GM Topical CreamSY60973042-077c-4265-988c-ad381f5603332
1014314triamcinolone acetonide 0.1 % Topical CreamPSN4e400049-c763-56f7-e063-6294a90a6fd71
1014314triamcinolone acetonide 0.1 % Topical CreamPSN200bb913-a6ac-5a6b-e063-6294a90a161a1
1014314triamcinolone acetonide 0.1 % Topical CreamPSNabad7215-95d2-4171-95cf-fa768081fd3b1
1014314triamcinolone acetonide 0.1 % Topical CreamPSNc6e46d6f-c64d-4242-a56f-8aff96e689931
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCD200bb913-a6ac-5a6b-e063-6294a90a161a1
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCD4e400049-c763-56f7-e063-6294a90a6fd71
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCDabad7215-95d2-4171-95cf-fa768081fd3b1
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCDc6e46d6f-c64d-4242-a56f-8aff96e689931
1014314triamcinolone acetonide 0.1 % Topical CreamSYabad7215-95d2-4171-95cf-fa768081fd3b1
1014314triamcinolone acetonide 0.1 % Topical CreamSYc6e46d6f-c64d-4242-a56f-8aff96e689931
1014314triamcinolone acetonide 0.1 % Topical CreamSY200bb913-a6ac-5a6b-e063-6294a90a161a1
1014314triamcinolone acetonide 0.1 % Topical CreamSY4e400049-c763-56f7-e063-6294a90a6fd71
1014314triamcinolone acetonide 1 MG per GM Topical CreamSYc6e46d6f-c64d-4242-a56f-8aff96e689931
1014314triamcinolone acetonide 1 MG per GM Topical CreamSYabad7215-95d2-4171-95cf-fa768081fd3b1
1014314triamcinolone acetonide 1 MG per GM Topical CreamSY4e400049-c763-56f7-e063-6294a90a6fd71
1014314triamcinolone acetonide 1 MG per GM Topical CreamSY200bb913-a6ac-5a6b-e063-6294a90a161a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21922-062-3021922006230454 g in 1 JAR (21922-062-30) 454 g2024-03-16NoNoCurrent