Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025%
- Product NDC
- 21922-050
- 11-digit product format
- 219220050
- Labeler code
- 21922
- Product ID
- 21922-050_854a8cf5-cfcf-4189-af34-e111363266a1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025%
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Encube Ethicals, Inc.
- Application
- ANDA216943
- Marketing category
- ANDA
- Marketing start
- 2023-09-04
- Substance
- CLINDAMYCIN PHOSPHATE; TRETINOIN
- Active strength
- 10; .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 and Tretinoin Gel 1.2%/0.025%
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CLINDAMYCIN PHOSPHATE | 10 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 |
|---|
| 21922-050-05 | Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025% | 30 g in 1 TUBE | GEL | 30 | | 3 |
| 21922-050-05 | Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025% | 1 in 1 CARTON | GEL | 1 | | 3 |
| 21922-050-07 | Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025% | 1 in 1 CARTON | GEL | 1 | | 3 |
| 21922-050-07 | Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025% | 60 g in 1 TUBE | GEL | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21922-050 | CLINDAMYCIN PHOSPHATE AND TRETINOIN GEL 1.2%/0.025% GEL [ENCUBE ETHICALS PRIVATE LIMITED] | 2 | Current NDC, 4 package rows | 20231229_1f772408-52a3-45b2-b053-8fc78948983c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 21922-050-05 | 21922005005 | 1 TUBE in 1 CARTON (21922-050-05) / 30 g in 1 TUBE | 1 tube | 2023-09-04 | No | No | Current |
| 21922-050-07 | 21922005007 | 1 TUBE in 1 CARTON (21922-050-07) / 60 g in 1 TUBE | 1 tube | 2023-09-04 | No | No | Current |