clindamycin palmitate hydrochloride (pediatric)

Generic: clindamycin palmitate hydrochloride (pediatric)

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clindamycin palmitate hydrochloride (pediatric)
Generic Name clindamycin palmitate hydrochloride (pediatric)
Labeler northstar rx llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

clindamycin palmitate hydrochloride 75 mg/5mL

Manufacturer
NorthStar Rx LLC

Identifiers & Regulatory

Product NDC 16714-483
Product ID 16714-483_366c8a71-1c5c-47e8-989d-d04503c65f4b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202409
Listing Expiration 2026-12-31
Marketing Start 2013-04-30

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 16714483
Hyphenated Format 16714-483

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 (pediatric) (source: ndc)
Application Number ANDA202409 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (16714-483-01) / 100 mL in 1 BOTTLE
  • 1 BOTTLE, PLASTIC in 1 CARTON (16714-483-02) / 100 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (2)

16714-483-01 1 BOTTLE in 1 CARTON (16714-483-01) / 100 mL in 1 BOTTLE 16714-483-02 1 BOTTLE, PLASTIC in 1 CARTON (16714-483-02) / 100 mL in 1 BOTTLE, PLASTIC

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": "366c8a71-1c5c-47e8-989d-d04503c65f4b", "openfda": {"unii": ["VN9A8JM7M7"], "rxcui": ["562266"], "spl_set_id": ["b35e3714-44d1-4e6a-a124-555ad259fec1"], "manufacturer_name": ["NorthStar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (16714-483-01)  / 100 mL in 1 BOTTLE", "package_ndc": "16714-483-01", "marketing_end_date": "20261231", "marketing_start_date": "20130430"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (16714-483-02)  / 100 mL in 1 BOTTLE, PLASTIC", "package_ndc": "16714-483-02", "marketing_start_date": "20221114"}], "brand_name": "Clindamycin Palmitate Hydrochloride (Pediatric)", "product_id": "16714-483_366c8a71-1c5c-47e8-989d-d04503c65f4b", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Lincosamide Antibacterial [EPC]", "Lincosamides [CS]", "Neuromuscular Blockade [PE]"], "product_ndc": "16714-483", "generic_name": "Clindamycin Palmitate Hydrochloride (Pediatric)", "labeler_name": "NorthStar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clindamycin Palmitate Hydrochloride (Pediatric)", "active_ingredients": [{"name": "CLINDAMYCIN PALMITATE HYDROCHLORIDE", "strength": "75 mg/5mL"}], "application_number": "ANDA202409", "marketing_category": "ANDA", "marketing_start_date": "20130430", "listing_expiration_date": "20261231"}