FDA.reportPublic FDA data

TRIAMCINOLONE ACETONIDE

Product NDC
70752-130
11-digit product format
707520130
Labeler code
70752
Product ID
70752-130_9922be09-ec29-44db-a22b-12e98ba5007d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRIAMCINOLONE ACETONIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
QUAGEN PHARMACEUTICALS LLC
Application
ANDA213559
Marketing category
ANDA
Marketing start
2020-07-01
Substance
TRIAMCINOLONE ACETONIDE
Active strength
1 mg/mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF446C597KA
Rxcui1085741, 1085745

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70752-130-052023-02-15C16284748780-1f386c649-fad3-0266-e053-dadaa90a7c1aTriamcinolone Acetonide Lotion, USP 0.025% and 0.1% For Topical Use Only Rx only
70752-130-052023-01-30C16284748780-1f386c649-fad3-0266-e053-dadaa90a7c1aTriamcinolone Acetonide Lotion, USP 0.025% and 0.1% For Topical Use Only Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70752-130-05TRIAMCINOLONE ACETONIDE60 mL in 1 BOTTLE, WITH APPLICATORLOTION604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70752-130-05ML - Milliliter70752-130b6f376ad-3def-49aa-9afb-3ef4a1b94a9a12021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70752-130TRIAMCINOLONE ACETONIDE LOTION [QUAGEN PHARMACEUTICALS LLC]3Current NDC, Legacy NDC, 1 package rows20230217_4c6ff738-60a3-4339-8e94-26fb9df65841.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1085745triamcinolone acetonide 0.1 % Topical LotionPSNf85e36df-15d8-4b8f-94a5-39742d572804103
1085745triamcinolone acetonide 1 MG/ML Topical LotionSCDf85e36df-15d8-4b8f-94a5-39742d572804103
1085745triamcinolone acetonide 0.1 % Topical LotionSYf85e36df-15d8-4b8f-94a5-39742d572804103
1085741triamcinolone acetonide 0.025 % Topical LotionPSN4c6ff738-60a3-4339-8e94-26fb9df658414
1085745triamcinolone acetonide 0.1 % Topical LotionPSN4c6ff738-60a3-4339-8e94-26fb9df658414
1085741triamcinolone acetonide 0.25 MG/ML Topical LotionSCD4c6ff738-60a3-4339-8e94-26fb9df658414
1085745triamcinolone acetonide 1 MG/ML Topical LotionSCD4c6ff738-60a3-4339-8e94-26fb9df658414
1085741triamcinolone acetonide 0.025 % Topical LotionSY4c6ff738-60a3-4339-8e94-26fb9df658414
1085745triamcinolone acetonide 0.1 % Topical LotionSY4c6ff738-60a3-4339-8e94-26fb9df658414

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70752-130-057075201300560 mL in 1 BOTTLE, WITH APPLICATOR (70752-130-05) 60 ml2020-07-010000-00-00NoNoCurrent