Clindamycin Phosphate and Benzoyl Peroxide
- Product NDC
- 51672-1367
- 11-digit product format
- 516721367
- Labeler code
- 51672
- Product ID
- 51672-1367_390b7e1e-a389-c3e6-e063-6394a90aa3aa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clindamycin Phosphate and Benzoyl Peroxide
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA206575
- Marketing category
- ANDA
- Marketing start
- 2019-08-19
- Substance
- BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
- Active strength
- 25; 10 mg/g; mg/g
- Pharmacologic classes
- Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Clindamycin Phosphate and Benzoyl Peroxide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BENZOYL PEROXIDE | 25 mg/g |
| CLINDAMYCIN PHOSPHATE | 10 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | W9WZN9A0GM, EH6D7113I8 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51672-1367-3 | Clindamycin Phosphate and Benzoyl Peroxide | 50 g in 1 BOTTLE, PUMP | GEL | 50 | | 5 |
| 51672-1367-3 | Clindamycin Phosphate and Benzoyl Peroxide | 1 in 1 CARTON | GEL | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51672-1367 | CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE GEL [TARO PHARMACEUTICALS U.S.A., INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20201015_0a98fc1e-be75-4c22-a7a7-2e4f033b3701.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51672-1367-3 | 51672136703 | 1 BOTTLE, PUMP in 1 CARTON (51672-1367-3) / 50 g in 1 BOTTLE, PUMP | 2019-08-19 | 0000-00-00 | No | No | Current |