TRIAMCINOLONE ACETONIDE

Product NDC
61919-619
11-digit product format
619190619
Labeler code
61919
Product ID
61919-619_4d3a81d3-8f47-ac04-e063-6394a90a545d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRIAMCINOLONE ACETONIDE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
DIRECTRX
Application
ANDA087385
Marketing category
ANDA
Marketing start
2021-02-04
Substance
TRIAMCINOLONE ACETONIDE
Active strength
1 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

openFDA Listing Details

Product ID
61919-619_4d3a81d3-8f47-ac04-e063-6394a90a545d
SPL ID
4d3a81d3-8f47-ac04-e063-6394a90a545d
Product type
HUMAN PRESCRIPTION DRUG
Finished product
Yes
Brand name base
TRIAMCINOLONE ACETONIDE
Generic name
TRIAMCINOLONE ACETONIDE
Dosage form
OINTMENT
Route
TOPICAL
Marketing start
2021-02-04
Marketing category
ANDA
Application number
ANDA087385
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA]; Corticosteroid [EPC]
Listing expiration
2027-12-31

openFDA Active Ingredients

IngredientStrength
TRIAMCINOLONE ACETONIDE1 mg/g

openFDA Harmonized Identifiers

FieldValues
UniiF446C597KA
Rxcui1014314, 1085636
Spl Set Id835bbcd1-3869-646c-e053-2a91aa0a796a
Manufacturer NameDIRECTRX

openFDA Package Details

Package NDCDescriptionMarketing startSample
61919-619-1515 g in 1 TUBE (61919-619-15)2021-02-04No

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
F446C597KATRIAMCINOLONE ACETONIDE76-25-5TRIAMCINOLONE ACETONIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61919-619-156191906191515 g in 1 TUBE (61919-619-15) 15 g2021-02-04NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
TRIAMCINOLONE ACETONIDE 0.1% 15gDIRECTRX2026-03-17HUMAN PRESCRIPTION DRUG LABEL3