clindamycin palmitate hydrochloride (pediatric) (64980-511)

Drug Facts

Product Profile

Brand Name clindamycin palmitate hydrochloride (pediatric)

Generic Name clindamycin palmitate hydrochloride

Labeler rising pharma holdings, inc.

Dosage Form GRANULE, FOR SOLUTION

Routes

ORAL

Active Ingredients

clindamycin palmitate hydrochloride 75 mg/5mL

Manufacturer

Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 64980-511

Product ID 64980-511_dbaca08e-0bce-412b-b46f-2a92bc597d8e

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA201821

Listing Expiration 2026-12-31

Marketing Start 2012-09-11

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 64980511

Hyphenated Format 64980-511

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 ANDA201821 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

75 mg/5mL

source: ndc

Packaging

100 mL in 1 BOTTLE (64980-511-10)

source: ndc

Packages (1)

64980-511-10 100 mL in 1 BOTTLE (64980-511-10)

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": "dbaca08e-0bce-412b-b46f-2a92bc597d8e", "openfda": {"unii": ["VN9A8JM7M7"], "rxcui": ["562266"], "spl_set_id": ["0800afad-e4cd-4f70-aaa1-a14547be4729"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 BOTTLE (64980-511-10)", "package_ndc": "64980-511-10", "marketing_start_date": "20190612"}], "brand_name": "CLINDAMYCIN PALMITATE HYDROCHLORIDE (Pediatric)", "product_id": "64980-511_dbaca08e-0bce-412b-b46f-2a92bc597d8e", "dosage_form": "GRANULE, FOR SOLUTION", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Lincosamide Antibacterial [EPC]", "Lincosamides [CS]", "Neuromuscular Blockade [PE]"], "product_ndc": "64980-511", "generic_name": "CLINDAMYCIN PALMITATE HYDROCHLORIDE", "labeler_name": "Rising Pharma Holdings, Inc.", "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": "ANDA201821", "marketing_category": "ANDA", "marketing_start_date": "20120911", "listing_expiration_date": "20261231"}