FDA.reportPublic FDA data

TRIAMCINOLONE ACETONIDE

Product NDC
70752-140
Requested package NDC
70752-140-17
11-digit product format
707520140
Labeler code
70752
Product ID
70752-140_169c7648-6f18-42cc-a6a9-c96a9bc16e9a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRIAMCINOLONE ACETONIDE
Dosage form
PASTE
Route
DENTAL
Labeler
QUAGEN PHARMACEUTICALS LLC
Application
ANDA214582
Marketing category
ANDA
Marketing start
2023-01-15
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
A214582-001TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE0.1%PASTE / DENTALAT2022-12-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214582-001AT

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
2026-02-19 14:30 UTC2026-02A214582-001TRIAMCINOLONE ACETONIDE0.1%PASTE / DENTALAT2022-12-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214582-001TRIAMCINOLONE ACETONIDE0.1%PASTE / DENTALAT2022-12-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A214582-001TRIAMCINOLONE ACETONIDE0.1%PASTE / DENTALAT2022-12-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214582-001TRIAMCINOLONE ACETONIDE0.1%PASTE / DENTALAT2022-12-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214582-001TRIAMCINOLONE ACETONIDE0.1%PASTE / DENTALAT2022-12-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214582-001TRIAMCINOLONE ACETONIDE0.1%PASTE / DENTALAT2022-12-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214582-001TRIAMCINOLONE ACETONIDE0.1%PASTE / DENTALAT2022-12-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214582-001TRIAMCINOLONE ACETONIDE0.1%PASTE / DENTALAT2022-12-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214582-001TRIAMCINOLONE ACETONIDE0.1%PASTE / DENTALAT2022-12-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214582-001TRIAMCINOLONE ACETONIDE0.1%PASTE / DENTALAT2022-12-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214582-001TRIAMCINOLONE ACETONIDE0.1%PASTE / DENTALAT2022-12-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214582-001TRIAMCINOLONE ACETONIDE0.1%PASTE / DENTALAT2022-12-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214582-001TRIAMCINOLONE ACETONIDE0.1%PASTE / DENTALAT2022-12-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214582-001TRIAMCINOLONE ACETONIDE0.1%PASTE / DENTALAT2022-12-098072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214582-001TRIAMCINOLONE ACETONIDE0.1%PASTE / DENTALAT2022-12-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214582-001TRIAMCINOLONE ACETONIDE0.1%PASTE / DENTALAT2022-12-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214582-001TRIAMCINOLONE ACETONIDE0.1%PASTE / DENTALAT2022-12-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214582-001TRIAMCINOLONE ACETONIDE0.1%PASTE / DENTALAT2022-12-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214582-001TRIAMCINOLONE ACETONIDE0.1%PASTE / DENTALAT2022-12-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214582-001TRIAMCINOLONE ACETONIDE0.1%PASTE / DENTALAT2022-12-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214582-001TRIAMCINOLONE ACETONIDE0.1%PASTE / DENTALAT2022-12-093f0d92c62455…
2023-05-13 08:27 UTC2023-05A214582-001TRIAMCINOLONE ACETONIDE0.1%PASTE / DENTALAT2022-12-09053a50430f4f…
2023-01-26 05:58 UTC2023-01A214582-001TRIAMCINOLONE ACETONIDE0.1%PASTE / DENTALAT2022-12-093bdfa0b2c4d7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214582-001TRIAMCINOLONE ACETONIDE0.1%PASTE / DENTALAT2022-12-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A214582-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214582-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214582-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214582-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214582-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214582-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214582-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214582-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214582-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214582-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214582-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214582-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214582-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214582-001AT18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214582-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214582-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214582-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214582-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214582-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214582-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214582-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A214582-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A214582-001AT13bdfa0b2c4d7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214582-001AT1a50c72e98297…

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1085728Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
22c80caa-730e-41c4-b772-18a369e76885Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70752-140-16TRIAMCINOLONE ACETONIDE5 g in 1 TUBEPASTE54
70752-140-16TRIAMCINOLONE ACETONIDE1 in 1 CARTONPASTE14
70752-140-17TRIAMCINOLONE ACETONIDE5 g in 1 TUBEPASTE54
70752-140-17TRIAMCINOLONE ACETONIDE1 in 1 CARTONPASTE14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70752-140-17GM - Gram70752-140158776e8-b448-49cc-ae22-8326c08b015b12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70752-140TRIAMCINOLONE ACETONIDE PASTE [QUAGEN PHARMACEUTICALS LLC]4Current NDC, 4 package rows20230217_22c80caa-730e-41c4-b772-18a369e76885.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEBryant Ranch Prepackc2b12aa8-1875-489b-8d16-fb588ad3cf542024-11-20Adverse reactionsExact identifier
application applno (ANDA): 214582
application number: ANDA214582
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEQUAGEN PHARMACEUTICALS LLC22c80caa-730e-41c4-b772-18a369e768852023-02-15Adverse reactionsExact identifier
application applno (ANDA): 214582
application number: ANDA214582
ndc (package): 70752-140-17
ndc (product): 70752-140
ndc11 (package): 70752014017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1085728triamcinolone acetonide 0.1 % Oral PastePSNc2b12aa8-1875-489b-8d16-fb588ad3cf54102
1085728triamcinolone acetonide 0.001 MG/MG Oral PasteSCDc2b12aa8-1875-489b-8d16-fb588ad3cf54102
1085728triamcinolone acetonide 0.1 % Dental PasteSYc2b12aa8-1875-489b-8d16-fb588ad3cf54102
1085728triamcinolone acetonide 1 MG per GM Oral PasteSYc2b12aa8-1875-489b-8d16-fb588ad3cf54102
1085728triamcinolone acetonide 0.1 % Oral PastePSN22c80caa-730e-41c4-b772-18a369e768854
1085728triamcinolone acetonide 0.001 MG/MG Oral PasteSCD22c80caa-730e-41c4-b772-18a369e768854
1085728triamcinolone acetonide 0.1 % Dental PasteSY22c80caa-730e-41c4-b772-18a369e768854
1085728triamcinolone acetonide 1 MG per GM Oral PasteSY22c80caa-730e-41c4-b772-18a369e768854

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70752-140-17707520140171 TUBE in 1 CARTON (70752-140-17) / 5 g in 1 TUBE1 tube2023-01-15NoNoCurrent