NDC 0299-5950

TRI-LUMA

Fluocinolone Acetonide, Hydroquinone, And Tretinoin

TRI-LUMA is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Galderma Laboratories, L.p.. The primary component is Fluocinolone Acetonide; Hydroquinone; Tretinoin.

• Product ID: 0299-5950_00d67032-56e1-477a-9306-9e27d201bfda
• NDC: 0299-5950
• Product Type: Human Prescription Drug
• Proprietary Name: TRI-LUMA
• Generic Name: Fluocinolone Acetonide, Hydroquinone, And Tretinoin
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2002-01-18
• Marketing Category: NDA / NDA
• Application Number: NDA021112
• Labeler Name: Galderma Laboratories, L.P.
• Substance Name: FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN
• Active Ingredient Strength: 0 mg/g; mg/g; mg/g
• Pharm Classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Depigmenting Activity [PE], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA], Retinoid [EPC], Retinoids [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0299-5950-02

1 TUBE in 1 BLISTER PACK (0299-5950-02) > 3 g in 1 TUBE

• Marketing Start Date: 2012-04-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0299-5950-30 [00299595030]

TRI-LUMA CREAM

• Marketing Category: NDA
• Application Number: NDA021112
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2007-01-18

NDC 0299-5950-02 [00299595002]

TRI-LUMA CREAM

• Marketing Category: NDA
• Application Number: NDA021112
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-04-01

Drug Details

Active Ingredients

Ingredient	Strength
FLUOCINOLONE ACETONIDE	.1 mg/g

OpenFDA Data

• SPL SET ID: a35fa709-5eb5-4429-b38f-f1e0019bf0ee
• Manufacturer:
  • Galderma Laboratories, L.P.
• UNII:
  • 0CD5FD6S2M
  • 5688UTC01R
  • XV74C1N1AE
• RxNorm Concept Unique ID - RxCUI:
  • 1191262
  • 1191264
• UPC Code:
  • 0302995950309

Pharmacological Class

• Corticosteroid [EPC]
• Corticosteroid Hormone Receptor Agonists [MoA]
• Melanin Synthesis Inhibitor [EPC]
• Melanin Synthesis Inhibitors [MoA]
• Depigmenting Activity [PE]
• Retinoid [EPC]
• Retinoids [CS]