Prescription drug · NDA
Duobrii (Halobetasol propionate and tazarotene) NDC 0187-0653
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 | 0018706530100187065301 | 1 TUBE in 1 CARTON (0187-0653-01) / 100 g in 1 TUBEMarketed from Apr 25, 2019 | |
| 0187-0653-03 | 0018706530300187065303 | 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, LLCNDC labeler code 0187
- 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.
About NDC 0187-0653
- What is NDC 0187-0653?
- 0187-0653 is the product NDC for Duobrii, Halobetasol propionate .1 mg/g; Tazarotene .45 mg/g lotion, listed with the FDA by Bausch Health US, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Duobrii (Halobetasol propionate and tazarotene).
- What is the active ingredient?
- Halobetasol propionate, Tazarotene.
- Who is the labeler?
- Bausch Health US, LLC, NDC labeler code 0187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Duobrii?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.