clindamycin palmitate hydrochloride (pediatric) (65162-468)

Drug Facts

Product Profile

Brand Name clindamycin palmitate hydrochloride (pediatric)

Generic Name clindamycin palmitate hydrochloride

Labeler amneal pharmaceuticals llc

Dosage Form POWDER, FOR SOLUTION

Routes

ORAL

Active Ingredients

clindamycin palmitate hydrochloride 75 mg/5mL

Manufacturer

Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-468

Product ID 65162-468_4480ac35-28fd-48fc-b0eb-52349d30ad8e

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA203513

Listing Expiration 2026-12-31

Marketing Start 2013-09-02

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 65162468

Hyphenated Format 65162-468

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 (65162-468-19) / 100 mL in 1 BOTTLE

source: ndc

Packages (1)

65162-468-19 1 BOTTLE in 1 CARTON (65162-468-19) / 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": "4480ac35-28fd-48fc-b0eb-52349d30ad8e", "openfda": {"unii": ["VN9A8JM7M7"], "rxcui": ["562266"], "spl_set_id": ["a85e28ea-03be-471f-ad7f-f5c55c67ac97"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (65162-468-19)  / 100 mL in 1 BOTTLE", "package_ndc": "65162-468-19", "marketing_start_date": "20130902"}], "brand_name": "Clindamycin Palmitate Hydrochloride (Pediatric)", "product_id": "65162-468_4480ac35-28fd-48fc-b0eb-52349d30ad8e", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Lincosamide Antibacterial [EPC]", "Lincosamides [CS]", "Neuromuscular Blockade [PE]"], "product_ndc": "65162-468", "generic_name": "Clindamycin Palmitate Hydrochloride", "labeler_name": "Amneal Pharmaceuticals 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": "20130902", "listing_expiration_date": "20261231"}