Prescription drug · ANDA
Clindamycin Phosphate and Benzoyl Peroxide (Clindamycin phosphate, benzoyl peroxide) NDC 63629-8635
Benzoyl peroxide 25 mg/g; Clindamycin phosphate 10 mg/g · Gel · Topical · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8635-1 | 6362986350163629863501 | 1 BOTTLE, PUMP in 1 CARTON (63629-8635-1) / 50 g in 1 BOTTLE, PUMPMarketed from Sep 12, 2019 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Generic name (nonproprietary)
- clindamycin phosphate, benzoyl peroxide
- Active ingredients
- Benzoyl peroxide — 25 mg/gClindamycin phosphate — 10 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205397
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
- Identifiers
- Product ID 63629-8635_00b68cb4-a998-8fe9-e063-6294a90abd17SPL ID 00b68cb4-a998-8fe9-e063-6294a90abd17SPL set ID ac7f5c47-a06a-495f-a914-13c930106c8dUNII W9WZN9A0GM, EH6D7113I8
- 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
N463629863501followed by a unit qualifier and the quantityPackage 63629-8635-01. 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)
Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% is indicated for the topical treatment of acne vulgaris in patients 12 years or older. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% is a combination of clindamycin phosphate (a lincosamide antibacterial) and benzoyl peroxide indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
Excerpt only. Read the full label for complete information.
About NDC 63629-8635
- What is NDC 63629-8635?
- 63629-8635 is the product NDC for Clindamycin Phosphate and Benzoyl Peroxide, Benzoyl peroxide 25 mg/g; Clindamycin phosphate 10 mg/g gel, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Clindamycin Phosphate and Benzoyl Peroxide (Clindamycin Phosphate, Benzoyl Peroxide).
- What is the active ingredient?
- Benzoyl peroxide, Clindamycin phosphate.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 63629. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Clindamycin Phosphate and Benzoyl Peroxide?
- 16 other product NDCs are listed under this name. See all Clindamycin Phosphate and Benzoyl Peroxide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Clindamycin Phosphate and Benzoyl Peroxide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Clindamycin Phosphate and Benzoyl Peroxide | Clindamycin phosphate 10 mg/g; Benzoyl peroxide 37.5 mg/g | GelTopical | Mayne Pharma | 68308-127 | 68308-0127-50 |
| Clindamycin Phosphate And Benzoyl Peroxide | Clindamycin phosphate 10 mg/g; Benzoyl peroxide 25 mg/g | GelTopical | Encube Ethicals, Inc. | 21922-074 | 21922-0074-40 |
| Clindamycin Phosphate and Benzoyl Peroxide | Clindamycin phosphate 10 mg/g; Benzoyl peroxide 37.5 mg/g | GelTopical | Padagis Israel Pharmaceuticals Ltd | 45802-383 | 45802-0383-01 |
| Clindamycin Phosphate and Benzoyl Peroxide | Clindamycin phosphate 10 mg/g; Benzoyl peroxide 37.5 mg/g | GelTopical | Bryant Ranch Prepack | 72162-2419 | 72162-2419-02 |
| Clindamycin Phosphate and Benzoyl Peroxide | Clindamycin phosphate 10 mg/g; Benzoyl peroxide 37.5 mg/g | GelTopical | Oceanside Pharmaceuticals | 68682-133 | 68682-0133-50 |
| Clindamycin Phosphate and Benzoyl Peroxideclindamycin phosphate, benzoyl peroxide | Benzoyl peroxide 25 mg/g; Clindamycin phosphate 10 mg/g | GelTopical | Padagis Israel Pharmaceuticals Ltd | 45802-597 | 45802-0597-01 |
| Clindamycin Phosphate and Benzoyl Peroxideclindamycin phosphate, benzoyl peroxide | Benzoyl peroxide 25 mg/g; Clindamycin phosphate 10 mg/g | GelTopical | Bryant Ranch Prepack | 72162-2077 | 72162-2077-01 |
| Clindamycin Phosphate and Benzoyl Peroxide | Clindamycin phosphate 10 mg/g; Benzoyl peroxide 25 mg/g | GelTopical | Sun Pharmaceutical Industries, Inc. | 51672-1367 | 51672-1367-03 |
| Clindamycin Phosphate and Benzoyl Peroxide | Clindamycin phosphate 10 mg/g; Benzoyl peroxide 50 mg/g | GelTopical | Zydus Pharmaceuticals USA Inc. | 70710-1445 | 70710-1445-04 |
| Clindamycin Phosphate and Benzoyl Peroxide | Clindamycin phosphate 10 mg/g; Benzoyl peroxide 50 mg/g | GelTopical | Zydus Lifesciences Limited | 70771-1450 | 70771-1450-04 |
Other NDCs under ANDA 205397
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 Peroxideclindamycin phosphate, benzoyl peroxide | Benzoyl peroxide 25 mg/g; Clindamycin phosphate 10 mg/g | GelTopical | Padagis Israel Pharmaceuticals Ltd | 45802-597 |
| Clindamycin Phosphate and Benzoyl Peroxideclindamycin phosphate, benzoyl peroxide | Benzoyl peroxide 25 mg/g; Clindamycin phosphate 10 mg/g | GelTopical | Bryant Ranch Prepack | 72162-2077 |