FDA.reportPublic FDA data

Clindamycin Phosphate

Product NDC
45802-263
11-digit product format
458020263
Labeler code
45802
Product ID
45802-263_5256413f-c2fa-4f07-8b0a-dc6d1de9539c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin Phosphate
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA065049
Marketing category
ANDA
Marketing start
2006-05-31
Substance
CLINDAMYCIN PHOSPHATE
Active strength
10 mg/mL
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clindamycin Phosphate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLINDAMYCIN PHOSPHATE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEH6D7113I8
Rxcui309333

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
1426d8f8-b7d5-4053-8554-613df00c0d86Product name220250616
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d8f81258-db12-0761-46cc-8ff6e62e9302Product name420240422
b7b2fa42-1c77-d724-81f0-87da60a77e79Product name320240320
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
b27c7c65-51f2-a62f-e0e6-a26b3a0f8eb0Product name320230425
e3af9708-3004-7392-4046-5311eaa8bab5Product name320221128
ffb4bacf-f636-0f7d-0b0d-7a4b151243e3Product name920220928
b72227d6-0388-43bd-995b-b762d2754cd5Product name120220706
a92d22e0-3af4-f301-bc88-27ff030b0070Product name220220316
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
5ce6ce33-4f2b-3ce0-757d-e520013280cfProduct name520180719
b92a26f1-6926-4817-be73-e26ab4c2146fProduct name120170602
028d6c95-5012-6976-2075-dee0ae6fefe2Product name120140508
468b2c08-8adb-8d0f-8257-c6515a061424Product name120140508
8959fb29-d86f-c521-666a-b4cb22233594Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-263-37Clindamycin Phosphate1 mL in 1 APPLICATORSOLUTION115
45802-263-37Clindamycin Phosphate60 in 1 JARSOLUTION6015
45802-263-93Clindamycin Phosphate1 mL in 1 APPLICATORSOLUTION115
45802-263-93Clindamycin Phosphate69 in 1 JARSOLUTION6915

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-263-37EA - Each45802-2638f989471-8d32-488c-a6ad-046ffd2f941e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Clindamycin PhosphateACTIVE INGREDIENTEH6D7113I8CLINDAMYCIN PHOSPHATE SOLUTION [PERRIGO NEW YORK INC]4
ClindamycinACTIVE MOIETY3U02EL437CCLINDAMYCIN PHOSPHATE SOLUTION [PERRIGO NEW YORK INC]4
Isopropyl AlcoholINACTIVE INGREDIENTND2M416302CLINDAMYCIN PHOSPHATE SOLUTION [PERRIGO NEW YORK INC]4
Propylene glycolINACTIVE INGREDIENT6DC9Q167V3CLINDAMYCIN PHOSPHATE SOLUTION [PERRIGO NEW YORK INC]4
Sodium HydroxideINACTIVE INGREDIENT55X04QC32ICLINDAMYCIN PHOSPHATE SOLUTION [PERRIGO NEW YORK INC]4
WaterINACTIVE INGREDIENT059QF0KO0RCLINDAMYCIN PHOSPHATE SOLUTION [PERRIGO NEW YORK INC]4
CLINDAMYCIN PHOSPHATEACTIVE INGREDIENTEH6D7113I8CLINDAMYCIN PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
CLINDAMYCINACTIVE MOIETY3U02EL437CCLINDAMYCIN PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302CLINDAMYCIN PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CLINDAMYCIN PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICLINDAMYCIN PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RCLINDAMYCIN PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-263CLINDAMYCIN PHOSPHATE SOLUTION [PADAGIS ISRAEL PHARMACEUTICALS LTD]13Current NDC, Legacy NDC, 4 package rows20230523_e492d645-7d2e-4f8a-a43a-9999456e9f72.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309333clindamycin phosphate 1 % Topical SolutionPSNe492d645-7d2e-4f8a-a43a-9999456e9f7215
309333clindamycin 10 MG/ML Topical SolutionSCDe492d645-7d2e-4f8a-a43a-9999456e9f7215
309333clindamycin (as clindamycin phosphate) 1 % Topical SolutionSYe492d645-7d2e-4f8a-a43a-9999456e9f7215
309333clindamycin 1 % Topical SolutionSYe492d645-7d2e-4f8a-a43a-9999456e9f7215
309333clindamycin phosphate 1 % Topical SolutionPSN9cf27a58-6c5f-4a02-88cc-b5ce3ecd87519
309333clindamycin 10 MG/ML Topical SolutionSCD9cf27a58-6c5f-4a02-88cc-b5ce3ecd87519
309333clindamycin (as clindamycin phosphate) 1 % Topical SolutionSY9cf27a58-6c5f-4a02-88cc-b5ce3ecd87519
309333clindamycin 1 % Topical SolutionSY9cf27a58-6c5f-4a02-88cc-b5ce3ecd87519
309333clindamycin phosphate 1 % Topical SolutionPSN13b6d419-83f8-4997-97bd-3c88855c684e2
309333clindamycin 10 MG/ML Topical SolutionSCD13b6d419-83f8-4997-97bd-3c88855c684e2
309333clindamycin (as clindamycin phosphate) 1 % Topical SolutionSY13b6d419-83f8-4997-97bd-3c88855c684e2
309333clindamycin 1 % Topical SolutionSY13b6d419-83f8-4997-97bd-3c88855c684e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-263-374580202633760 APPLICATOR in 1 JAR (45802-263-37) / 1 mL in 1 APPLICATOR60 applicator2006-05-310000-00-00NoNoCurrent
45802-263-93458020263931 mL in 1 APPLICATOR1 mlHistorical