Clindamycin Palmitate Hydrochloride

Product NDC
53746-468
11-digit product format
537460468
Labeler code
53746
Product ID
53746-468_b9016023-7843-48e3-8ff6-2e5a70aa5daf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin Palmitate Hydrochloride
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA203513
Marketing category
ANDA
Marketing start
2024-04-01
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
VN9A8JM7M7CLINDAMYCIN PALMITATE HYDROCHLORIDE25507-04-4CLINDAMYCIN PALMITATE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53746-468-19537460468191 BOTTLE in 1 CARTON (53746-468-19) / 100 mL in 1 BOTTLE1 bottle2024-04-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Clindamycin Palmitate Hydrochloride for Oral Solution, USPAmneal Pharmaceuticals of New York LLC | Amneal Pharmaceuticals Private Limited2024-04-01HUMAN PRESCRIPTION DRUG LABEL2