Clindamycin Phosphate and Benzoyl Peroxide
- Product NDC
- 51672-1403
- 11-digit product format
- 516721403
- Labeler code
- 51672
- Product ID
- 51672-1403_390cc1f4-9d3b-90f1-e063-6294a90ad136
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clindamycin Phosphate and Benzoyl Peroxide
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA208683
- Marketing category
- ANDA
- Marketing start
- 2018-06-05
- Substance
- BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
- Active strength
- 50; 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 | 50 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 |
|---|
| 51672-1403-4 | Clindamycin Phosphate and Benzoyl Peroxide | 50 g in 1 BOTTLE, PUMP | GEL | 50 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51672-1403 | CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE GEL [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20230202_449884c1-cf3b-4e2c-b8a0-82442ea8523a.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51672-1403-4 | 51672140304 | 50 g in 1 BOTTLE, PUMP (51672-1403-4) | 50 g | 2018-06-05 | 0000-00-00 | No | No | Current |