FDA.reportPublic FDA data

Triamcinolone Acetonide

Product NDC
0603-7862
11-digit product format
006037862
Labeler code
0603
Product ID
0603-7862_0e7996ef-d598-4807-afa3-a0329d0da5e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
triamcinolone acetonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Par Pharmaceutical
Application
ANDA040671
Marketing category
ANDA
Marketing start
2006-06-09
Marketing end
2019-07-31
Substance
TRIAMCINOLONE ACETONIDE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

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
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
e42f429b-c4e5-0402-e1c5-730154df4060Product name420240205
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
38d4de13-64b3-4057-b91c-4b5126962341Product name120220516
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
089e0644-1ea8-8654-4113-39f960dd57d5Product name320210115
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
5331c9c8-f64b-11e6-ccf1-071c477fcb0bProduct name720190612
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
9f64e0dc-109c-9660-8e0e-91ec987b3817Product name620171204
dfa879a3-32de-49f0-a7ba-9b9c3e13002fProduct name120171204
8de20f81-8411-4cf1-a8b2-03404ee56d01Product name320171109
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
a5f1a68c-0352-4f34-46a3-9b4eed239ed8Product name220160819
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
355b2224-0895-7135-83f5-d099a6a82a0aProduct name120140508
55be6b50-8cc0-f0f1-74a1-3416a91193aaProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
7a0092d1-1e8c-0d78-4f8d-d95fa15cc3cfProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
89b93c13-4be8-69f3-b33b-63e64feffb9bProduct name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0603-7862-90NEWSDS pak80 g in 1 TUBECREAM80 g1 mg in 1g2
0603-7862-90SanaDermRx SKin Repair80 g in 1 TUBECREAM80 g1 mg in 1g2
0603-7862-90NEWSDS pak80 g in 1 TUBECREAM80 g1 mg in 1g1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0603-7862NEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]2Legacy NDC20151114_24749639-0fa6-6a6c-e054-00144ff88e88.zip
0603-7862SANADERMRX SKIN REPAIR (TRIAMCINOLONE ACETONIDE CREAM KIT) KIT [GENPAK SOLUTIONS, LLC]2Legacy NDC20151019_17e3afd1-3526-4324-a756-1a426dfe7875.zip
0603-7862NEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]1Legacy NDC20151113_24664e10-3424-6186-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259090dimethicone 5 % Topical CreamPSN17e3afd1-3526-4324-a756-1a426dfe78752
259090dimethicone 5 % Topical CreamPSN24749639-0fa6-6a6c-e054-00144ff88e882
1014314triamcinolone acetonide 0.1 % Topical CreamPSN17e3afd1-3526-4324-a756-1a426dfe78752
1014314triamcinolone acetonide 0.1 % Topical CreamPSN24749639-0fa6-6a6c-e054-00144ff88e882
259090dimethicone 50 MG/ML Topical CreamSCD17e3afd1-3526-4324-a756-1a426dfe78752
259090dimethicone 50 MG/ML Topical CreamSCD24749639-0fa6-6a6c-e054-00144ff88e882
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCD17e3afd1-3526-4324-a756-1a426dfe78752
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCD24749639-0fa6-6a6c-e054-00144ff88e882
259090dimethicone 5 % Topical CreamSY17e3afd1-3526-4324-a756-1a426dfe78752
259090dimethicone 5 % Topical CreamSY24749639-0fa6-6a6c-e054-00144ff88e882
1014314triamcinolone acetonide 0.1 % Topical CreamSY17e3afd1-3526-4324-a756-1a426dfe78752
1014314triamcinolone acetonide 0.1 % Topical CreamSY24749639-0fa6-6a6c-e054-00144ff88e882
1014314triamcinolone acetonide 1 MG per GM Topical CreamSY24749639-0fa6-6a6c-e054-00144ff88e882
1014314triamcinolone acetonide 1 MG per GM Topical CreamSY17e3afd1-3526-4324-a756-1a426dfe78752
259090dimethicone 5 % Topical CreamPSN24664e10-3424-6186-e054-00144ff88e881
1014314triamcinolone acetonide 0.1 % Topical CreamPSN24664e10-3424-6186-e054-00144ff88e881
259090dimethicone 50 MG/ML Topical CreamSCD24664e10-3424-6186-e054-00144ff88e881
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCD24664e10-3424-6186-e054-00144ff88e881
259090dimethicone 5 % Topical CreamSY24664e10-3424-6186-e054-00144ff88e881
1014314triamcinolone acetonide 0.1 % Topical CreamSY24664e10-3424-6186-e054-00144ff88e881
1014314triamcinolone acetonide 1 MG per GM Topical CreamSY24664e10-3424-6186-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
0603-7862-900060378629080 g in 1 TUBE80 gHistorical