Prescription drug · NDA
Cabtreo NDC 0187-0006
clindamycin phosphate/benzoyl peroxide/adapalene · Clindamycin phosphate 12 mg/g + 2 more ingredients · Gel · Topical · Bausch Health US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0187-0006-10 | 00187000610 | 1 BOTTLE, PUMP in 1 CARTON (0187-0006-10) / 20 g in 1 BOTTLE, PUMPMarketed from Oct 20, 2023 | |
| 0187-0006-25 | 00187000625 | 1 BOTTLE, PUMP in 1 CARTON (0187-0006-25) / 50 g in 1 BOTTLE, PUMPMarketed from Oct 20, 2023 | |
| 0187-0006-35 | 00187000635 | 3.5 g in 1 TUBE (0187-0006-35)Marketed from Oct 20, 2023 · 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)
- Cabtreo
- Generic name (nonproprietary)
- clindamycin phosphate/benzoyl peroxide/adapalene
- Active ingredients
- Clindamycin phosphate — 12 mg/gBenzoyl peroxide — 31 mg/gAdapalene — 1.5 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Bausch Health US LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 216632
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)Retinoids (Chemical structure)
- Identifiers
- Product ID 0187-0006_338bc721-434d-cbc2-e063-6394a90abc47SPL ID 338bc721-434d-cbc2-e063-6394a90abc47SPL set ID 9468da0f-9978-4c58-8135-0274c3415084RxCUI 2668198, 2668204UNII EH6D7113I8, W9WZN9A0GM, 1L4806J2QF
- Pharmacologic class
- Lincosamide Antibacterial; 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
N400187000610followed by a unit qualifier and the quantityPackage 00187-0006-10. 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)
CABTREO is indicated for the topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older. CABTREO is a combination of clindamycin phosphate (a lincosamide antibacterial), adapalene (a retinoid), and benzoyl peroxide indicated for the topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older. ( 1 )
Excerpt only. Read the full label for complete information.