XACIATO
- Product NDC
- 78206-189
- 11-digit product format
- 782060189
- Labeler code
- 78206
- Product ID
- 78206-189_1319a6c2-eed2-49b6-9ec8-85d44fae9b91
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- clindamycin phosphate
- Dosage form
- GEL
- Route
- VAGINAL
- Labeler
- Organon LLC
- Application
- NDA215650
- Marketing category
- NDA
- Marketing start
- 2023-10-13
- Substance
- CLINDAMYCIN PHOSPHATE
- Active strength
- 100 mg/5g
- Pharmacologic classes
- Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- XACIATO
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CLINDAMYCIN PHOSPHATE | 100 mg/5g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | EH6D7113I8 |
| Rxcui | 2587810, 2587815 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 78206-189-01 | XACIATO | 8 g in 1 TUBE | GEL | 8 | | 13 |
| 78206-189-01 | XACIATO | 1 in 1 CARTON | GEL | 1 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 78206-189 | XACIATO (CLINDAMYCIN PHOSPHATE) GEL [ORGANON LLC] | 11 | Current NDC, 2 package rows | 20240217_0423007f-28fa-4159-bf58-9174626d2347.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 |
|---|
| 78206-189-01 | 78206018901 | 1 TUBE in 1 CARTON (78206-189-01) / 8 g in 1 TUBE | 1 tube | 2023-10-13 | No | No | Current |