Clindamycin Palmitate Hydrochloride (Pediatric)
- Product NDC
- 16714-483
- 11-digit product format
- 167140483
- Labeler code
- 16714
- Product ID
- 16714-483_366c8a71-1c5c-47e8-989d-d04503c65f4b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clindamycin Palmitate Hydrochloride (Pediatric)
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- NorthStar Rx LLC
- Application
- ANDA202409
- Marketing category
- ANDA
- Marketing start
- 2013-04-30
- 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 (Pediatric)
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CLINDAMYCIN PALMITATE HYDROCHLORIDE | 75 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VN9A8JM7M7 |
| Rxcui | 562266 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16714-483-01 | Clindamycin Palmitate Hydrochloride (Pediatric) | 100 mL in 1 BOTTLE | SOLUTION | 100 | | 12 |
| 16714-483-01 | Clindamycin Palmitate Hydrochloride (Pediatric) | 1 in 1 CARTON | SOLUTION | 1 | | 12 |
| 16714-483-02 | Clindamycin Palmitate Hydrochloride (Pediatric) | 1 in 1 CARTON | SOLUTION | 1 | | 12 |
| 16714-483-02 | Clindamycin Palmitate Hydrochloride (Pediatric) | 100 mL in 1 BOTTLE, PLASTIC | SOLUTION | 100 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16714-483 | CLINDAMYCIN PALMITATE HYDROCHLORIDE (PEDIATRIC) SOLUTION [NORTHSTAR RX LLC] | 12 | Current NDC, Legacy NDC, 4 package rows | 20240723_b35e3714-44d1-4e6a-a124-555ad259fec1.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 |
|---|
| 16714-483-01 | 16714048301 | 1 BOTTLE in 1 CARTON (16714-483-01) / 100 mL in 1 BOTTLE | 1 bottle | 2013-04-30 | 2026-12-31 | No | No | Current |
| 16714-483-02 | 16714048302 | 1 BOTTLE, PLASTIC in 1 CARTON (16714-483-02) / 100 mL in 1 BOTTLE, PLASTIC | | 2022-11-14 | | No | No | Historical |