Prescription drug · ANDA
Clindamycin Phosphate and Benzoyl Peroxide NDC 70710-1445
Clindamycin phosphate 10 mg/g; Benzoyl peroxide 50 mg/g · Gel · Topical · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70710-1445-4 | 7071014450470710144504 | 1 TUBE in 1 CARTON (70710-1445-4) / 45 g in 1 TUBEMarketed from Mar 7, 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 and benzoyl peroxide
- Active ingredients
- Clindamycin phosphate — 10 mg/gBenzoyl peroxide — 50 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Zydus Pharmaceuticals USA Inc.NDC labeler code 70710
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210794
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
- Identifiers
- Product ID 70710-1445_96b1eb6c-b99b-4509-a8eb-424123aead6aSPL ID 96b1eb6c-b99b-4509-a8eb-424123aead6aSPL set ID 83d52507-99a1-4461-b067-5ec01dc6c5d3RxCUI 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
N470710144504followed by a unit qualifier and the quantityPackage 70710-1445-04. 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 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 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 benzoyl peroxide …
Excerpt only. Read the full label for complete information.
About NDC 70710-1445
- What is NDC 70710-1445?
- 70710-1445 is the product NDC for Clindamycin Phosphate and Benzoyl Peroxide, Clindamycin phosphate 10 mg/g; Benzoyl peroxide 50 mg/g gel, listed with the FDA by Zydus Pharmaceuticals USA Inc.. 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.
- What is the active ingredient?
- Clindamycin phosphate, Benzoyl peroxide.
- Who is the labeler?
- Zydus Pharmaceuticals USA Inc., NDC labeler code 70710. 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 | 63629-8635 | 63629-8635-01 |
| 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 Lifesciences Limited | 70771-1450 | 70771-1450-04 |
Other NDCs under ANDA 210794
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 10 mg/g; Benzoyl peroxide 50 mg/g | GelTopical | Zydus Lifesciences Limited | 70771-1450 |