clindesse

Generic: clindamycin phosphate

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name clindesse
Generic Name clindamycin phosphate
Labeler padagis israel pharmaceuticals ltd
Dosage Form CREAM
Routes
VAGINAL
Active Ingredients

clindamycin phosphate 100 mg/5g

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-042
Product ID 45802-042_ab0a6fe2-5ee0-408c-9e1d-30ce29344d16
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050793
Listing Expiration 2027-12-31
Marketing Start 2015-07-03

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 45802042
Hyphenated Format 45802-042

Supplemental Identifiers

RxCUI
309337 602427
UNII
EH6D7113I8

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 clindesse (source: ndc)
Generic Name clindamycin phosphate (source: ndc)
Application Number NDA050793 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5g
source: ndc
Packaging
  • 1 APPLICATOR in 1 CARTON (45802-042-01) / 5 g in 1 APPLICATOR
  • 1 APPLICATOR in 1 CARTON (45802-042-02) / 5 g in 1 APPLICATOR
source: ndc

Packages (2)

45802-042-01 1 APPLICATOR in 1 CARTON (45802-042-01) / 5 g in 1 APPLICATOR 45802-042-02 1 APPLICATOR in 1 CARTON (45802-042-02) / 5 g in 1 APPLICATOR

Ingredients (1)

clindamycin phosphate (100 mg/5g)

Linked Drug Pages (1)

Clindesse ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "ab0a6fe2-5ee0-408c-9e1d-30ce29344d16", "openfda": {"unii": ["EH6D7113I8"], "rxcui": ["309337", "602427"], "spl_set_id": ["fe8bb204-f173-44fe-803b-b08f2ec5aa31"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 APPLICATOR in 1 CARTON (45802-042-01)  / 5 g in 1 APPLICATOR", "package_ndc": "45802-042-01", "marketing_start_date": "20150703"}, {"sample": true, "description": "1 APPLICATOR in 1 CARTON (45802-042-02)  / 5 g in 1 APPLICATOR", "package_ndc": "45802-042-02", "marketing_start_date": "20150703"}], "brand_name": "Clindesse", "product_id": "45802-042_ab0a6fe2-5ee0-408c-9e1d-30ce29344d16", "dosage_form": "CREAM", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Lincosamide Antibacterial [EPC]", "Lincosamides [CS]", "Neuromuscular Blockade [PE]"], "product_ndc": "45802-042", "generic_name": "clindamycin phosphate", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clindesse", "active_ingredients": [{"name": "CLINDAMYCIN PHOSPHATE", "strength": "100 mg/5g"}], "application_number": "NDA050793", "marketing_category": "NDA", "marketing_start_date": "20150703", "listing_expiration_date": "20271231"}