Tri-Luma NDC 0299-5950

NDC codes

FDA NDC Directory

Product NDC (as listed)0299-5950Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00299-5950Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0299-5950-02	00299595002	1 TUBE in 1 BLISTER PACK (0299-5950-02) / 3 g in 1 TUBEMarketed from Apr 1, 2012 · Sample package
0299-5950-30	00299595030	1 TUBE in 1 CARTON (0299-5950-30) / 30 g in 1 TUBEMarketed from Jan 18, 2007

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Tri-Luma
Generic name (nonproprietary): fluocinolone acetonide, hydroquinone, and tretinoin
Active ingredients: Fluocinolone acetonide — .1 mg/gHydroquinone — 40 mg/gTretinoin — .5 mg/g
Dosage form: Cream
Route: Topical
Labeler: Galderma Laboratories, L.P.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 021112
Marketing start: Jan 18, 2002
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)Depigmenting Activity (Physiologic effect)Melanin Synthesis Inhibitors (Mechanism)Retinoids (Chemical structure)
Identifiers: Product ID 0299-5950_253d914c-6f0e-c833-e063-6394a90a7ca5SPL ID 253d914c-6f0e-c833-e063-6394a90a7ca5SPL set ID a35fa709-5eb5-4429-b38f-f1e0019bf0eeRxCUI 1191262, 1191264UNII 0CD5FD6S2M, XV74C1N1AE, 5688UTC01R
Pharmacologic class: Corticosteroid; Melanin Synthesis Inhibitor; Retinoid

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400299595002 followed by a unit qualifier and the quantity

Package 00299-5950-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Oct 24, 2024.

Indications (excerpt from the label)

TRI-LUMA Cream is a combination of fluocinolone acetonide (a corticosteroid), hydroquinone (a melanin synthesis inhibitor), and tretinoin (a retinoid) that is indicated for the short-term treatment of moderate to severe melasma of the face, in the presence of measures for sun avoidance, including the use of sunscreens. ( 1 ) 1.1 Indication TRI-LUMA Cream is a combination of fluocinolone acetonide (a corticosteroid), hydroquinone (a melanin synthesis inhibitor), and tretinoin (a retinoid) that is indicated for the short-term treatment of moderate to severe melasma of the face, in the presence of measures for sun avoidance, including the use of sunscreens. 1.2 Limitations of Use TRI-LUMA Cream…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)