Clindamycin Palmitate Hydrochloride
- Product NDC
- 65162-468
- 11-digit product format
- 651620468
- Labeler code
- 65162
- Product ID
- 65162-468_4480ac35-28fd-48fc-b0eb-52349d30ad8e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clindamycin Palmitate Hydrochloride
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA203513
- Marketing category
- ANDA
- Marketing start
- 2013-09-02
- Substance
- CLINDAMYCIN PALMITATE HYDROCHLORIDE
- Active strength
- 75 mg/5mL
- 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 Palmitate Hydrochloride
- Brand name suffix
- (Pediatric)
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CLINDAMYCIN PALMITATE HYDROCHLORIDE | 75 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VN9A8JM7M7 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65162-468-19 | Clindamycin Palmitate Hydrochloride(Pediatric) | 100 mL in 1 BOTTLE | POWDER, FOR SOLUTION | 100 | | 17 |
| 65162-468-19 | Clindamycin Palmitate Hydrochloride(Pediatric) | 1 in 1 CARTON | POWDER, FOR SOLUTION | 1 | | 17 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CLINDAMYCIN PALMITATE HYDROCHLORIDE | ACTIVE INGREDIENT | VN9A8JM7M7 | CLINDAMYCIN PALMITATE HYDROCHLORIDE POWDER, FOR SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 5 | |
| CLINDAMYCIN | ACTIVE MOIETY | 3U02EL437C | CLINDAMYCIN PALMITATE HYDROCHLORIDE POWDER, FOR SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 5 | |
| CHERRY | INACTIVE INGREDIENT | BUC5I9595W | CLINDAMYCIN PALMITATE HYDROCHLORIDE POWDER, FOR SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 5 | |
| ETHYLPARABEN | INACTIVE INGREDIENT | 14255EXE39 | CLINDAMYCIN PALMITATE HYDROCHLORIDE POWDER, FOR SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 5 | |
| MALTODEXTRIN | INACTIVE INGREDIENT | 7CVR7L4A2D | CLINDAMYCIN PALMITATE HYDROCHLORIDE POWDER, FOR SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 5 | |
| POLOXAMER 188 | INACTIVE INGREDIENT | LQA7B6G8JG | CLINDAMYCIN PALMITATE HYDROCHLORIDE POWDER, FOR SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 5 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | CLINDAMYCIN PALMITATE HYDROCHLORIDE POWDER, FOR SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-468 | CLINDAMYCIN PALMITATE HYDROCHLORIDE (PEDIATRIC) (CLINDAMYCIN PALMITATE HYDROCHLORIDE) POWDER, FOR SOLUTION [AMNEAL PHARMACEUTICALS LLC] | 17 | Current NDC, Legacy NDC, 2 package rows | 20241027_a85e28ea-03be-471f-ad7f-f5c55c67ac97.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 |
|---|
| 65162-468-19 | 65162046819 | 1 BOTTLE in 1 CARTON (65162-468-19) / 100 mL in 1 BOTTLE | 1 bottle | 2013-09-02 | 0000-00-00 | No | No | Current |