tri-luma

Generic: fluocinolone acetonide, hydroquinone, and tretinoin

Labeler: galderma laboratories, l.p.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tri-luma
Generic Name fluocinolone acetonide, hydroquinone, and tretinoin
Labeler galderma laboratories, l.p.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

fluocinolone acetonide .1 mg/g, hydroquinone 40 mg/g, tretinoin .5 mg/g

Manufacturer
Galderma Laboratories, L.P.

Identifiers & Regulatory

Product NDC 0299-5950
Product ID 0299-5950_253d914c-6f0e-c833-e063-6394a90a7ca5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021112
Listing Expiration 2026-12-31
Marketing Start 2002-01-18

Pharmacologic Class

Established (EPC)
corticosteroid [epc] melanin synthesis inhibitor [epc] retinoid [epc]
Mechanism of Action
corticosteroid hormone receptor agonists [moa] melanin synthesis inhibitors [moa]
Chemical Structure
retinoids [cs]
Physiologic Effect
depigmenting activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02995950
Hyphenated Format 0299-5950

Supplemental Identifiers

RxCUI
1191262 1191264
UNII
0CD5FD6S2M XV74C1N1AE 5688UTC01R
NUI
N0000175576 N0000175450 N0000175851 N0000175854 N0000175850 N0000175607 M0018962

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 tri-luma (source: ndc)
Generic Name fluocinolone acetonide, hydroquinone, and tretinoin (source: ndc)
Application Number NDA021112 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .1 mg/g
  • 40 mg/g
  • .5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 BLISTER PACK (0299-5950-02) / 3 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0299-5950-30) / 30 g in 1 TUBE
source: ndc

Packages (2)

0299-5950-02 1 TUBE in 1 BLISTER PACK (0299-5950-02) / 3 g in 1 TUBE 0299-5950-30 1 TUBE in 1 CARTON (0299-5950-30) / 30 g in 1 TUBE

Ingredients (3)

fluocinolone acetonide (.1 mg/g) hydroquinone (40 mg/g) tretinoin (.5 mg/g)

Linked Drug Pages (1)

TRI-LUMA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "253d914c-6f0e-c833-e063-6394a90a7ca5", "openfda": {"nui": ["N0000175576", "N0000175450", "N0000175851", "N0000175854", "N0000175850", "N0000175607", "M0018962"], "unii": ["0CD5FD6S2M", "XV74C1N1AE", "5688UTC01R"], "rxcui": ["1191262", "1191264"], "spl_set_id": ["a35fa709-5eb5-4429-b38f-f1e0019bf0ee"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_pe": ["Depigmenting Activity [PE]"], "pharm_class_epc": ["Corticosteroid [EPC]", "Melanin Synthesis Inhibitor [EPC]", "Retinoid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Melanin Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Galderma Laboratories, L.P."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 TUBE in 1 BLISTER PACK (0299-5950-02)  / 3 g in 1 TUBE", "package_ndc": "0299-5950-02", "marketing_start_date": "20120401"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0299-5950-30)  / 30 g in 1 TUBE", "package_ndc": "0299-5950-30", "marketing_start_date": "20070118"}], "brand_name": "TRI-LUMA", "product_id": "0299-5950_253d914c-6f0e-c833-e063-6394a90a7ca5", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "Depigmenting Activity [PE]", "Melanin Synthesis Inhibitor [EPC]", "Melanin Synthesis Inhibitors [MoA]", "Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "0299-5950", "generic_name": "fluocinolone acetonide, hydroquinone, and tretinoin", "labeler_name": "Galderma Laboratories, L.P.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TRI-LUMA", "active_ingredients": [{"name": "FLUOCINOLONE ACETONIDE", "strength": ".1 mg/g"}, {"name": "HYDROQUINONE", "strength": "40 mg/g"}, {"name": "TRETINOIN", "strength": ".5 mg/g"}], "application_number": "NDA021112", "marketing_category": "NDA", "marketing_start_date": "20020118", "listing_expiration_date": "20261231"}