FDA.reportPublic FDA data

Oralone

Product NDC
51672-1335
11-digit product format
516721335
Labeler code
51672
Product ID
51672-1335_3961db48-e5fb-c2d8-e063-6294a90ab8ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamcinolone Acetonide
Dosage form
PASTE
Route
DENTAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA070730
Marketing category
ANDA
Marketing start
1986-10-01
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIAMCINOLONE ACETONIDE1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF446C597KA
Rxcui1085728, 1085767

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
51672-1335-5Oralone1 in 1 CARTONPASTE14
51672-1335-5Oralone5 g in 1 TUBEPASTE54
51672-1335-8Oralone7.5 g in 1 TUBEPASTE7.54
51672-1335-8Oralone1 in 1 CARTONPASTE14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1335-5GM - Gram51672-133526bf845e-7f60-4ae6-b943-a21c66e7017312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Triamcinolone AcetonideACTIVE INGREDIENTF446C597KAORALONE (TRIAMCINOLONE ACETONIDE) PASTE [TARO PHARMACEUTICALS U.S.A., INC.]2
TriamcinoloneACTIVE MOIETY1ZK20VI6TYORALONE (TRIAMCINOLONE ACETONIDE) PASTE [TARO PHARMACEUTICALS U.S.A., INC.]2
carboxymethylcellulose sodiumINACTIVE INGREDIENTK679OBS311ORALONE (TRIAMCINOLONE ACETONIDE) PASTE [TARO PHARMACEUTICALS U.S.A., INC.]2
GelatinINACTIVE INGREDIENT2G86QN327LORALONE (TRIAMCINOLONE ACETONIDE) PASTE [TARO PHARMACEUTICALS U.S.A., INC.]2
mineral oilINACTIVE INGREDIENTT5L8T28FGPORALONE (TRIAMCINOLONE ACETONIDE) PASTE [TARO PHARMACEUTICALS U.S.A., INC.]2
pectinINACTIVE INGREDIENT89NA02M4RXORALONE (TRIAMCINOLONE ACETONIDE) PASTE [TARO PHARMACEUTICALS U.S.A., INC.]2
Polyethylene GlycolINACTIVE INGREDIENT3WJQ0SDW1AORALONE (TRIAMCINOLONE ACETONIDE) PASTE [TARO PHARMACEUTICALS U.S.A., INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1335ORALONE (TRIAMCINOLONE ACETONIDE) PASTE [TARO PHARMACEUTICALS U.S.A., INC.]3Current NDC, Legacy NDC, 4 package rows20190208_ac1e2116-795e-4c20-974d-11fa07cf0fa7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1085767Oralone 0.1 % Oral PastePSNac1e2116-795e-4c20-974d-11fa07cf0fa74
1085728triamcinolone acetonide 0.1 % Oral PastePSNac1e2116-795e-4c20-974d-11fa07cf0fa74
1085767triamcinolone acetonide 0.001 MG/MG Oral Paste [Oralone]SBDac1e2116-795e-4c20-974d-11fa07cf0fa74
1085728triamcinolone acetonide 0.001 MG/MG Oral PasteSCDac1e2116-795e-4c20-974d-11fa07cf0fa74
1085767Oralone 0.001 MG/MG Oral PasteSYac1e2116-795e-4c20-974d-11fa07cf0fa74
1085767Oralone 0.1 % Oral PasteSYac1e2116-795e-4c20-974d-11fa07cf0fa74
1085728triamcinolone acetonide 0.1 % Dental PasteSYac1e2116-795e-4c20-974d-11fa07cf0fa74
1085728triamcinolone acetonide 1 MG per GM Oral PasteSYac1e2116-795e-4c20-974d-11fa07cf0fa74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1335-5516721335051 TUBE in 1 CARTON (51672-1335-5) / 5 g in 1 TUBE1 tube1986-10-010000-00-00NoNoCurrent
51672-1335-8516721335081 TUBE in 1 CARTON (51672-1335-8) / 7.5 g in 1 TUBE1 tube1986-10-010000-00-00NoNoCurrent