clindamycin palmitate hydrochloride (pediatric)

Generic: clindamycin palmitate hydrochloride

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clindamycin palmitate hydrochloride (pediatric)
Generic Name clindamycin palmitate hydrochloride
Labeler amneal pharmaceuticals of new york llc
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

clindamycin palmitate hydrochloride 75 mg/5mL

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 53746-468
Product ID 53746-468_b9016023-7843-48e3-8ff6-2e5a70aa5daf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203513
Listing Expiration 2026-12-31
Marketing Start 2024-04-01

Pharmacologic Class

Classes
decreased sebaceous gland activity [pe] lincosamide antibacterial [epc] lincosamides [cs] neuromuscular blockade [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53746468
Hyphenated Format 53746-468

Supplemental Identifiers

RxCUI
562266
UNII
VN9A8JM7M7

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name clindamycin palmitate hydrochloride (pediatric) (source: ndc)
Generic Name clindamycin palmitate hydrochloride (source: ndc)
Application Number ANDA203513 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (53746-468-19) / 100 mL in 1 BOTTLE
source: ndc

Packages (1)

53746-468-19 1 BOTTLE in 1 CARTON (53746-468-19) / 100 mL in 1 BOTTLE

Ingredients (1)

clindamycin palmitate hydrochloride (75 mg/5mL)

Linked Drug Pages (1)

Clindamycin Palmitate Hydrochloride (Pediatric) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b9016023-7843-48e3-8ff6-2e5a70aa5daf", "openfda": {"unii": ["VN9A8JM7M7"], "rxcui": ["562266"], "spl_set_id": ["faf67eb8-1fd7-4b2c-a55b-24ba664c0dce"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (53746-468-19)  / 100 mL in 1 BOTTLE", "package_ndc": "53746-468-19", "marketing_start_date": "20240401"}], "brand_name": "Clindamycin Palmitate Hydrochloride (Pediatric)", "product_id": "53746-468_b9016023-7843-48e3-8ff6-2e5a70aa5daf", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Lincosamide Antibacterial [EPC]", "Lincosamides [CS]", "Neuromuscular Blockade [PE]"], "product_ndc": "53746-468", "generic_name": "Clindamycin Palmitate Hydrochloride", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clindamycin Palmitate Hydrochloride", "brand_name_suffix": "(Pediatric)", "active_ingredients": [{"name": "CLINDAMYCIN PALMITATE HYDROCHLORIDE", "strength": "75 mg/5mL"}], "application_number": "ANDA203513", "marketing_category": "ANDA", "marketing_start_date": "20240401", "listing_expiration_date": "20261231"}