Prescription drug · ANDA
Clindamycin Phosphate and Benzoyl Peroxide NDC 0378-8688
Kit · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-8688-35 | 0037886883500378868835 | 1 KIT in 1 CARTON (0378-8688-35) * 5 g in 1 BOTTLE, PLASTIC * 20 g in 1 JARMarketed from Sep 19, 2014 |
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)
- Clindamycin Phosphate and Benzoyl Peroxide
- Generic name (nonproprietary)
- clindamycin phosphate and benzoyl peroxide
- Dosage form
- Kit
- Labeler
- Mylan Pharmaceuticals Inc.NDC labeler code 0378
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065443
- Marketing start
- Listing expires
- Identifiers
- Product ID 0378-8688_7ab087d0-276c-4b45-9685-9e6dc5ea1920SPL ID 7ab087d0-276c-4b45-9685-9e6dc5ea1920SPL set ID 96b3e35a-e174-49cd-8695-acd7d23e7710RxCUI 308689, 358917
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N400378868835followed by a unit qualifier and the quantityPackage 00378-8688-35. 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)
INDICATIONS AND USAGE Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% is indicated for the topical treatment of acne vulgaris.
Excerpt only. Read the full label for complete information.
About NDC 0378-8688
- What is NDC 0378-8688?
- 0378-8688 is the product NDC for Clindamycin Phosphate and Benzoyl Peroxide kit, listed with the FDA by Mylan Pharmaceuticals 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.
- Who is the labeler?
- Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 Pharmaceuticals USA Inc. | 70710-1445 | 70710-1445-04 |