Prescription drug · NDA
Duobrii NDC 0187-0653
halobetasol propionate and tazarotene · Halobetasol propionate .1 mg/g; Tazarotene .45 mg/g · Lotion · Topical · Bausch Health US, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0187-0653-01 | 00187065301 | 1 TUBE in 1 CARTON (0187-0653-01) / 100 g in 1 TUBEMarketed from Apr 25, 2019 | |
| 0187-0653-03 | 00187065303 | 6 TUBE in 1 CARTON (0187-0653-03) / 3 g in 1 TUBEMarketed from Apr 25, 2019 · Sample package |
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)
- Duobrii
- Generic name (nonproprietary)
- halobetasol propionate and tazarotene
- Active ingredients
- Halobetasol propionate — .1 mg/gTazarotene — .45 mg/g
- Dosage form
- Lotion
- Route
- Topical
- Labeler
- Bausch Health US, LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 209354
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)Retinoids (Chemical structure)
- Identifiers
- Product ID 0187-0653_dbee276a-6a2e-4565-a106-09a5bcca8778SPL ID dbee276a-6a2e-4565-a106-09a5bcca8778SPL set ID b3f0cdc0-69fd-43d1-baf2-d776a3a20715RxCUI 2166089, 2166094UNII 91A0K1TY3Z, 81BDR9Y8PS
- Pharmacologic class
- Corticosteroid; 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
N400187065301followed by a unit qualifier and the quantityPackage 00187-0653-01. 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 .
Indications (excerpt from the label)
DUOBRII ® (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045% is indicated for the topical treatment of plaque psoriasis in adults. DUOBRII Lotion is a combination of halobetasol propionate and tazarotene indicated for the topical treatment of plaque psoriasis in adults. ( 1 )
Excerpt only. Read the full label for complete information.