FDA.reportPublic FDA data

triamcinolone acetonide

Product NDC
0168-0003
11-digit product format
001680003
Labeler code
0168
Product ID
0168-0003_c8c77210-0a99-47c9-8fe3-0f1531110ffa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
triamcinolone acetonide
Dosage form
CREAM
Route
TOPICAL
Labeler
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
Application
ANDA085692
Marketing category
ANDA
Marketing start
1978-03-09
Substance
TRIAMCINOLONE ACETONIDE
Active strength
.25 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
triamcinolone acetonide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIAMCINOLONE ACETONIDE.25 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF446C597KA
Rxcui1014314, 1085644, 1085686

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
089e0644-1ea8-8654-4113-39f960dd57d5Product name320210115
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
5331c9c8-f64b-11e6-ccf1-071c477fcb0bProduct name720190612
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
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
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct 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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0168-0003-15triamcinolone acetonide1 in 1 CARTONCREAM19
0168-0003-15triamcinolone acetonide15 g in 1 TUBECREAM159
0168-0003-80triamcinolone acetonide80 g in 1 TUBECREAM809
0168-0003-80triamcinolone acetonide1 in 1 CARTONCREAM19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0003-15GM - Gram0168-00039f3b1487-a5c8-4b05-a63a-fd6bd78302ae12012-07-24
0168-0003-80GM - Gram0168-0003997448cb-cbc7-4ec9-adbd-c1ade6aaddc512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
triamcinolone acetonideACTIVE INGREDIENTF446C597KATRIAMCINOLONE ACETONIDE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]5
triamcinolone acetonideACTIVE MOIETYF446C597KATRIAMCINOLONE ACETONIDE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]5
Benzyl AlcoholINACTIVE INGREDIENTLKG8494WBHTRIAMCINOLONE ACETONIDE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]5
Cetyl AlcoholINACTIVE INGREDIENT936JST6JCNTRIAMCINOLONE ACETONIDE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]5
GlycerinINACTIVE INGREDIENTPDC6A3C0OXTRIAMCINOLONE ACETONIDE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]5
Isopropyl PalmitateINACTIVE INGREDIENT8CRQ2TH63MTRIAMCINOLONE ACETONIDE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]5
Lactic AcidINACTIVE INGREDIENT33X04XA5ATTRIAMCINOLONE ACETONIDE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]5
SorbitolINACTIVE INGREDIENT506T60A25RTRIAMCINOLONE ACETONIDE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]5
WaterINACTIVE INGREDIENT059QF0KO0RTRIAMCINOLONE ACETONIDE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]5
TRIAMCINOLONE ACETONIDEACTIVE INGREDIENTF446C597KATRIAMCINOLONE ACETONIDE CREAM [PROFICIENT RX LP]2
TRIAMCINOLONE ACETONIDEACTIVE MOIETYF446C597KATRIAMCINOLONE ACETONIDE CREAM [PROFICIENT RX LP]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTRIAMCINOLONE ACETONIDE CREAM [PROFICIENT RX LP]2
Triamcinolone AcetonideACTIVE INGREDIENTF446C597KATRIAMCINOLONE ACETONIDE CREAM [REBEL DISTRIBUTORS CORP]1
TriamcinoloneACTIVE MOIETY1ZK20VI6TYTRIAMCINOLONE ACETONIDE CREAM [REBEL DISTRIBUTORS CORP]1
Benzyl AlcoholINACTIVE INGREDIENTLKG8494WBHTRIAMCINOLONE ACETONIDE CREAM [REBEL DISTRIBUTORS CORP]1
CERESININACTIVE INGREDIENTQ1LS2UJO3ATRIAMCINOLONE ACETONIDE CREAM [REBEL DISTRIBUTORS CORP]1
Cetyl AlcoholINACTIVE INGREDIENT936JST6JCNTRIAMCINOLONE ACETONIDE CREAM [REBEL DISTRIBUTORS CORP]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXTRIAMCINOLONE ACETONIDE CREAM [REBEL DISTRIBUTORS CORP]1
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MTRIAMCINOLONE ACETONIDE CREAM [REBEL DISTRIBUTORS CORP]1
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATTRIAMCINOLONE ACETONIDE CREAM [REBEL DISTRIBUTORS CORP]1
SORBITOLINACTIVE INGREDIENT506T60A25RTRIAMCINOLONE ACETONIDE CREAM [REBEL DISTRIBUTORS CORP]1
WaterINACTIVE INGREDIENT059QF0KO0RTRIAMCINOLONE ACETONIDE CREAM [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0168-0003TRIAMCINOLONE ACETONIDE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]8Current NDC, Legacy NDC, 4 package rows20180426_92a1ded0-8e1a-4994-9c8a-89e84fc85c94.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1085644triamcinolone acetonide 0.025 % Topical CreamPSN92a1ded0-8e1a-4994-9c8a-89e84fc85c949
1014314triamcinolone acetonide 0.1 % Topical CreamPSN92a1ded0-8e1a-4994-9c8a-89e84fc85c949
1085686triamcinolone acetonide 0.5 % Topical CreamPSN92a1ded0-8e1a-4994-9c8a-89e84fc85c949
1085644triamcinolone acetonide 0.25 MG/ML Topical CreamSCD92a1ded0-8e1a-4994-9c8a-89e84fc85c949
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCD92a1ded0-8e1a-4994-9c8a-89e84fc85c949
1085686triamcinolone acetonide 5 MG/ML Topical CreamSCD92a1ded0-8e1a-4994-9c8a-89e84fc85c949
1085644triamcinolone acetonide 0.025 % Topical CreamSY92a1ded0-8e1a-4994-9c8a-89e84fc85c949
1014314triamcinolone acetonide 0.1 % Topical CreamSY92a1ded0-8e1a-4994-9c8a-89e84fc85c949
1085686triamcinolone acetonide 0.5 % Topical CreamSY92a1ded0-8e1a-4994-9c8a-89e84fc85c949
1014314triamcinolone acetonide 1 MG per GM Topical CreamSY92a1ded0-8e1a-4994-9c8a-89e84fc85c949
1085644triamcinolone acetonide 0.025 % Topical CreamPSN2d6b9c2f-f1a0-413e-b333-64da523682027
1085644triamcinolone acetonide 0.25 MG/ML Topical CreamSCD2d6b9c2f-f1a0-413e-b333-64da523682027
1085644triamcinolone acetonide 0.025 % Topical CreamSY2d6b9c2f-f1a0-413e-b333-64da523682027
1085644triamcinolone acetonide 0.025 % Topical CreamPSN41c1fe93-0509-4cf6-ac35-049028b731de3
1085644triamcinolone acetonide 0.025 % Topical CreamPSN5701a07f-bd22-4bc7-95ff-0c5444ea59713
1014314triamcinolone acetonide 0.1 % Topical CreamPSN41c1fe93-0509-4cf6-ac35-049028b731de3
1085644triamcinolone acetonide 0.25 MG/ML Topical CreamSCD5701a07f-bd22-4bc7-95ff-0c5444ea59713
1085644triamcinolone acetonide 0.25 MG/ML Topical CreamSCD41c1fe93-0509-4cf6-ac35-049028b731de3
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCD41c1fe93-0509-4cf6-ac35-049028b731de3
1085644triamcinolone acetonide 0.025 % Topical CreamSY41c1fe93-0509-4cf6-ac35-049028b731de3
1085644triamcinolone acetonide 0.025 % Topical CreamSY5701a07f-bd22-4bc7-95ff-0c5444ea59713
1014314triamcinolone acetonide 0.1 % Topical CreamSY41c1fe93-0509-4cf6-ac35-049028b731de3
1014314triamcinolone acetonide 1 MG per GM Topical CreamSY41c1fe93-0509-4cf6-ac35-049028b731de3
1085644triamcinolone acetonide 0.025 % Topical CreamPSN063728a5-87b5-4b53-957a-d8e497fcf8b01
1014314triamcinolone acetonide 0.1 % Topical CreamPSN063728a5-87b5-4b53-957a-d8e497fcf8b01
1085686triamcinolone acetonide 0.5 % Topical CreamPSN063728a5-87b5-4b53-957a-d8e497fcf8b01
1085644triamcinolone acetonide 0.25 MG/ML Topical CreamSCD063728a5-87b5-4b53-957a-d8e497fcf8b01
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCD063728a5-87b5-4b53-957a-d8e497fcf8b01
1085686triamcinolone acetonide 5 MG/ML Topical CreamSCD063728a5-87b5-4b53-957a-d8e497fcf8b01
1085644triamcinolone acetonide 0.025 % Topical CreamSY063728a5-87b5-4b53-957a-d8e497fcf8b01
1014314triamcinolone acetonide 0.1 % Topical CreamSY063728a5-87b5-4b53-957a-d8e497fcf8b01
1085686triamcinolone acetonide 0.5 % Topical CreamSY063728a5-87b5-4b53-957a-d8e497fcf8b01
1014314triamcinolone acetonide 1 MG per GM Topical CreamSY063728a5-87b5-4b53-957a-d8e497fcf8b01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0168-0003-15001680003151 TUBE in 1 CARTON (0168-0003-15) / 15 g in 1 TUBE1 tube1978-03-090000-00-00NoNoCurrent
0168-0003-80001680003801 TUBE in 1 CARTON (0168-0003-80) / 80 g in 1 TUBE1 tube1978-03-090000-00-00NoNoCurrent