FDA.reportPublic FDA data

Triamcinolone Acetonide

Product NDC
0713-0225
11-digit product format
007130225
Labeler code
0713
Product ID
0713-0225_edbdc68d-056b-6aab-e053-2995a90a3fab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamcinolone Acetonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
ANDA089798
Marketing category
ANDA
Marketing start
2015-04-14
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0713-0225DDiscontinued by firm2026-08-03
excluded packagepackage0713-02250713-0225-15DDiscontinued by firm2026-08-03
excluded packagepackage0713-02250713-0225-31DDiscontinued by firm2026-08-03
excluded packagepackage0713-02250713-0225-80DDiscontinued by firm2026-08-03

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
A089798-001TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A089798-001AT

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-313f01610625f2…
2019-09-15 20:21 UTC2019-09A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-31cb3db0bc1861…
2026-08-01 22:54:322026-06A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-31a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089798-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089798-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089798-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089798-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089798-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089798-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089798-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A089798-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A089798-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A089798-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A089798-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A089798-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A089798-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A089798-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A089798-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A089798-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A089798-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A089798-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A089798-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A089798-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A089798-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A089798-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A089798-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A089798-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A089798-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A089798-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A089798-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A089798-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A089798-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A089798-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A089798-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A089798-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A089798-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A089798-001AT1cb3db0bc1861…
2026-08-01 22:54:322026-06A089798-001AT1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDECosette Pharmaceuticals, Inc.5b3bcc75-608d-23fd-91a5-0806d5fe32f52022-11-18Adverse reactionsExact identifier
application applno (ANDA): 089798
application number: ANDA089798
ndc (product): 0713-0225

Additional Listing Data#

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

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
1085644Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5b3bcc75-608d-23fd-91a5-0806d5fe32f5Available 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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
0713-0225-15Triamcinolone Acetonide1 in 1 CARTONCREAM114
0713-0225-15Triamcinolone Acetonide15 g in 1 TUBECREAM1514
0713-0225-31Triamcinolone Acetonide1 in 1 CARTONCREAM114
0713-0225-31Triamcinolone Acetonide30 g in 1 TUBECREAM3014
0713-0225-80Triamcinolone Acetonide1 in 1 CARTONCREAM114
0713-0225-80Triamcinolone Acetonide80 g in 1 TUBECREAM8014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0225-15GM - Gram0713-02250119c2f7-16e3-4993-a5fe-76ae3f040a5612015-11-12
0713-0225-31GM - Gram0713-0225ddf50734-cc21-4ee2-870c-ee68aa3d9d8112015-11-12
0713-0225-80GM - Gram0713-02250a62f831-9f23-4840-9d3c-7e04ab0dcedf12015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Triamcinolone AcetonideACTIVE INGREDIENTF446C597KATRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]7
Triamcinolone AcetonideACTIVE MOIETYF446C597KATRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]7
Cetyl AlcoholINACTIVE INGREDIENT936JST6JCNTRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]7
Isopropyl PalmitateINACTIVE INGREDIENT8CRQ2TH63MTRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]7
Lanolin AlcoholsINACTIVE INGREDIENT884C3FA9HETRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]7
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TTRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]7
Mineral OilINACTIVE INGREDIENTT5L8T28FGPTRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]7
Polyoxyl 40 StearateINACTIVE INGREDIENT13A4J4NH9ITRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]7
Polysorbate 60INACTIVE INGREDIENTCAL22UVI4MTRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]7
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]7
Propylene Glycol StearateINACTIVE INGREDIENTMZM1I680W0TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]7
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHTRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]7
Sorbic AcidINACTIVE INGREDIENTX045WJ989BTRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]7
Sorbitan MonostearateINACTIVE INGREDIENTNVZ4I0H58XTRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]7
WaterINACTIVE INGREDIENT059QF0KO0RTRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0225TRIAMCINOLONE ACETONIDE CREAM [COSETTE PHARMACEUTICALS, INC.]14Current NDC, Legacy NDC, 6 package rows20221119_5b3bcc75-608d-23fd-91a5-0806d5fe32f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1085644triamcinolone acetonide 0.025 % Topical CreamPSN5b3bcc75-608d-23fd-91a5-0806d5fe32f514
1014314triamcinolone acetonide 0.1 % Topical CreamPSN5b3bcc75-608d-23fd-91a5-0806d5fe32f514
1085644triamcinolone acetonide 0.25 MG/ML Topical CreamSCD5b3bcc75-608d-23fd-91a5-0806d5fe32f514
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCD5b3bcc75-608d-23fd-91a5-0806d5fe32f514
1085644triamcinolone acetonide 0.025 % Topical CreamSY5b3bcc75-608d-23fd-91a5-0806d5fe32f514
1014314triamcinolone acetonide 0.1 % Topical CreamSY5b3bcc75-608d-23fd-91a5-0806d5fe32f514
1014314triamcinolone acetonide 1 MG per GM Topical CreamSY5b3bcc75-608d-23fd-91a5-0806d5fe32f514
1014314triamcinolone acetonide 0.1 % Topical CreamPSN05affb10-e764-42cd-a1bd-2f8451b1247b5
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCD05affb10-e764-42cd-a1bd-2f8451b1247b5
1014314triamcinolone acetonide 0.1 % Topical CreamSY05affb10-e764-42cd-a1bd-2f8451b1247b5
1014314triamcinolone acetonide 1 MG per GM Topical CreamSY05affb10-e764-42cd-a1bd-2f8451b1247b5
1014314triamcinolone acetonide 0.1 % Topical CreamPSN239fce62-323c-29cb-e063-6394a90a4ddc1
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCD239fce62-323c-29cb-e063-6394a90a4ddc1
1014314triamcinolone acetonide 0.1 % Topical CreamSY239fce62-323c-29cb-e063-6394a90a4ddc1
1014314triamcinolone acetonide 1 MG per GM Topical CreamSY239fce62-323c-29cb-e063-6394a90a4ddc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0713-0225-15007130225151 TUBE in 1 CARTON (0713-0225-15) / 15 g in 1 TUBE1 tube2015-04-140000-00-00NoNoCurrent
0713-0225-31007130225311 TUBE in 1 CARTON (0713-0225-31) / 30 g in 1 TUBE1 tube2015-04-140000-00-00NoNoCurrent
0713-0225-80007130225801 TUBE in 1 CARTON (0713-0225-80) / 80 g in 1 TUBE1 tube2015-04-140000-00-00NoNoCurrent