triamcinolone acetonide

Generic: triamcinolone acetonide

Labeler: e. fougera & co. a division of fougera pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name triamcinolone acetonide
Generic Name triamcinolone acetonide
Labeler e. fougera & co. a division of fougera pharmaceuticals, llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

triamcinolone acetonide .25 mg/g

Manufacturer
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 0168-0003
Product ID 0168-0003_c8c77210-0a99-47c9-8fe3-0f1531110ffa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA085692
Listing Expiration 2027-12-31
Marketing Start 1978-03-09

Pharmacologic Class

Established (EPC)
corticosteroid [epc]
Mechanism of Action
corticosteroid hormone receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01680003
Hyphenated Format 0168-0003

Supplemental Identifiers

RxCUI
1014314 1085644 1085686
UPC
0301680004150 0301680003153 0301680002156
UNII
F446C597KA
NUI
N0000175576 N0000175450

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name triamcinolone acetonide (source: ndc)
Generic Name triamcinolone acetonide (source: ndc)
Application Number ANDA085692 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .25 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0168-0003-15) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0168-0003-80) / 80 g in 1 TUBE
source: ndc

Packages (2)

0168-0003-15 1 TUBE in 1 CARTON (0168-0003-15) / 15 g in 1 TUBE 0168-0003-80 1 TUBE in 1 CARTON (0168-0003-80) / 80 g in 1 TUBE

Ingredients (1)

triamcinolone acetonide (.25 mg/g)

Linked Drug Pages (1)

triamcinolone acetonide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "c8c77210-0a99-47c9-8fe3-0f1531110ffa", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0301680004150", "0301680003153", "0301680002156"], "unii": ["F446C597KA"], "rxcui": ["1014314", "1085644", "1085686"], "spl_set_id": ["92a1ded0-8e1a-4994-9c8a-89e84fc85c94"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0168-0003-15)  / 15 g in 1 TUBE", "package_ndc": "0168-0003-15", "marketing_start_date": "19780309"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0168-0003-80)  / 80 g in 1 TUBE", "package_ndc": "0168-0003-80", "marketing_start_date": "19780309"}], "brand_name": "triamcinolone acetonide", "product_id": "0168-0003_c8c77210-0a99-47c9-8fe3-0f1531110ffa", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0168-0003", "generic_name": "triamcinolone acetonide", "labeler_name": "E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "triamcinolone acetonide", "active_ingredients": [{"name": "TRIAMCINOLONE ACETONIDE", "strength": ".25 mg/g"}], "application_number": "ANDA085692", "marketing_category": "ANDA", "marketing_start_date": "19780309", "listing_expiration_date": "20271231"}