FDA.reportPublic FDA data

Triamcinolone Acetonide

Product NDC
68462-131
11-digit product format
684620131
Labeler code
68462
Product ID
68462-131_496c34f9-7262-4814-a065-fc59809748b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamcinolone Acetonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA207117
Marketing category
ANDA
Marketing start
2016-08-05
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
Triamcinolone Acetonide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIAMCINOLONE ACETONIDE1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF446C597KA
Rxcui1014314

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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-131-17Triamcinolone Acetonide1 in 1 CARTONCREAM12
68462-131-17Triamcinolone Acetonide15 g in 1 TUBECREAM152
68462-131-35Triamcinolone Acetonide1 in 1 CARTONCREAM12
68462-131-35Triamcinolone Acetonide30 g in 1 TUBECREAM302
68462-131-49Triamcinolone Acetonide80 g in 1 TUBECREAM802
68462-131-49Triamcinolone Acetonide1 in 1 CARTONCREAM12
68462-131-59Triamcinolone Acetonide454 g in 1 JARCREAM4542

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-131-17GM - Gram68462-1313d16000a-7a78-4cd8-a359-e4f3e341f79a12017-03-06
68462-131-35GM - Gram68462-131a3c5dfe7-a5be-454c-b547-e7806ecc56cc12017-03-06
68462-131-49GM - Gram68462-1317610d1c5-b172-4ce6-a8fc-950bbef94f8012017-03-06
68462-131-59GM - Gram68462-13177e6e0c8-4159-4428-81aa-c6336c0f551212017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-131TRIAMCINOLONE ACETONIDE CREAM [GLENMARK PHARMACEUTICALS INC., USA]2Current NDC, Legacy NDC, 7 package rows20240105_a9b3764d-fd3d-4fcc-8d22-5aa848da1b06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014314triamcinolone acetonide 0.1 % Topical CreamPSN2ea4f291-9488-5a2e-e054-00144ff88e882
1014314triamcinolone acetonide 0.1 % Topical CreamPSNa9b3764d-fd3d-4fcc-8d22-5aa848da1b062
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCD2ea4f291-9488-5a2e-e054-00144ff88e882
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCDa9b3764d-fd3d-4fcc-8d22-5aa848da1b062
1014314triamcinolone acetonide 0.1 % Topical CreamSY2ea4f291-9488-5a2e-e054-00144ff88e882
1014314triamcinolone acetonide 0.1 % Topical CreamSYa9b3764d-fd3d-4fcc-8d22-5aa848da1b062
1014314triamcinolone acetonide 1 MG per GM Topical CreamSY2ea4f291-9488-5a2e-e054-00144ff88e882
1014314triamcinolone acetonide 1 MG per GM Topical CreamSYa9b3764d-fd3d-4fcc-8d22-5aa848da1b062

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-131-17684620131171 TUBE in 1 CARTON (68462-131-17) / 15 g in 1 TUBE1 tube2016-08-050000-00-00NoNoCurrent
68462-131-35684620131351 TUBE in 1 CARTON (68462-131-35) / 30 g in 1 TUBE1 tube2016-08-050000-00-00NoNoCurrent
68462-131-49684620131491 TUBE in 1 CARTON (68462-131-49) / 80 g in 1 TUBE1 tube2016-08-050000-00-00NoNoCurrent
68462-131-5968462013159454 g in 1 JAR (68462-131-59) 454 g2016-08-050000-00-00NoNoCurrent