Clindamycin Phosphate 1.2% and Tretinoin 0.025%
- Product NDC
- 68682-300
- 11-digit product format
- 686820300
- Labeler code
- 68682
- Product ID
- 68682-300_282973c6-50ee-441b-ab65-52bb582bf30c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- clindamycin phosphate and tretinoin
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Oceanside Pharmaceuticals
- Application
- NDA050802
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2020-08-04
- Substance
- CLINDAMYCIN PHOSPHATE; TRETINOIN
- Active strength
- 12; .25 mg/g; mg/g
- Pharmacologic classes
- Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]
- 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 1.2% and Tretinoin 0.025%
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CLINDAMYCIN PHOSPHATE | 12 mg/g |
| TRETINOIN | .25 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | EH6D7113I8, 5688UTC01R |
| Rxcui | 882548 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68682-300-30 | Clindamycin Phosphate 1.2% and Tretinoin 0.025% | 1 in 1 CARTON | GEL | 1 | | 2 |
| 68682-300-30 | Clindamycin Phosphate 1.2% and Tretinoin 0.025% | 30 g in 1 TUBE | GEL | 30 | | 2 |
| 68682-300-60 | Clindamycin Phosphate 1.2% and Tretinoin 0.025% | 1 in 1 CARTON | GEL | 1 | | 2 |
| 68682-300-60 | Clindamycin Phosphate 1.2% and Tretinoin 0.025% | 60 g in 1 TUBE | GEL | 60 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68682-300 | CLINDAMYCIN PHOSPHATE 1.2% AND TRETINOIN 0.025% (CLINDAMYCIN PHOSPHATE AND TRETINOIN) GEL [OCEANSIDE PHARMACEUTICALS] | 1 | Current NDC, Legacy NDC, 4 package rows | 20200804_63b2e85d-8fe5-4f18-9e85-8492c49a7520.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68682-300-30 | 68682030030 | 1 TUBE in 1 CARTON (68682-300-30) / 30 g in 1 TUBE | 1 tube | 2020-08-04 | 0000-00-00 | No | No | Current |
| 68682-300-60 | 68682030060 | 1 TUBE in 1 CARTON (68682-300-60) / 60 g in 1 TUBE | 1 tube | 2020-08-04 | 0000-00-00 | No | No | Current |