Prescription drug · ANDA
Clindamycin Phosphate And Benzoyl Peroxide Clindamycin Phosphate And Benzoyl Peroxide NDC 21922-022
clindamycin phosphate and benzoyl peroxide · Clindamycin phosphate 10 mg/g; Benzoyl peroxide 50 mg/g · Gel · Topical · Encube Ethicals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 21922-022-06 | 21922002206 | 1 TUBE in 1 CARTON (21922-022-06) / 45 g in 1 TUBEMarketed from May 20, 2021 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Clindamycin Phosphate And Benzoyl Peroxide Clindamycin Phosphate And Benzoyl PeroxideSuffix: CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
- Generic name (nonproprietary)
- clindamycin phosphate and benzoyl peroxide
- Active ingredients
- Clindamycin phosphate — 10 mg/gBenzoyl peroxide — 50 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Encube Ethicals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212433
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
- Identifiers
- Product ID 21922-022_c3c0a548-d788-41fc-b2f8-99431a48cd05SPL ID c3c0a548-d788-41fc-b2f8-99431a48cd05SPL set ID 8ca01174-431e-449a-a85e-8c68d506776cRxCUI 1540241UNII EH6D7113I8, W9WZN9A0GM
- Pharmacologic class
- Lincosamide Antibacterial
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
N421922002206followed by a unit qualifier and the quantityPackage 21922-0022-06. 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)
Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is a combination of clindamycin phosphate (a lincosamide antibacterial) and benzoyl peroxide indicated for the topical treatment of inflammatory acne vulgaris. ( 1.1 ) Limitation of Use: Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% has not been demonstrated to have any additional benefit when compared with benzoyl peroxide alone in the same vehicle when used for the treatment of non-inflammatory acne. ( 1.2 ) 1.1 Indication Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is indicated for the topical treatment of inflammatory acne vulgaris in patients 12 years and older. 1.2 Limitations of Use Clindamycin Phosphate and…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 212433
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Clindamycin Phosphate And Benzoyl Peroxide Clindamycin Phosphate And Benzoyl Peroxideclindamycin phosphate and benzoyl peroxide | Clindamycin phosphate 10 mg/g; Benzoyl peroxide 50 mg/g | GelTopical | Bryant Ranch Prepack | 71335-2878 |
| Clindamycin Phosphate And Benzoyl Peroxide Clindamycin Phosphate And Benzoyl Peroxideclindamycin phosphate and benzoyl peroxide | Clindamycin phosphate 10 mg/g; Benzoyl peroxide 50 mg/g | GelTopical | Northstar Rx LLC | 72603-322 |
| Clindamycin Phosphate And Benzoyl Peroxide Clindamycin Phosphate And Benzoyl Peroxideclindamycin phosphate and benzoyl peroxide | Clindamycin phosphate 10 mg/g; Benzoyl peroxide 50 mg/g | GelTopical | Bryant Ranch Prepack | 72162-2299 |