FDA.reportPublic FDA data

Clindamycin Phosphate

Product NDC
45802-562
11-digit product format
458020562
Labeler code
45802
Product ID
45802-562_269f799d-6d9e-4643-87f7-97c30425e876
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin Phosphate
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA064050
Marketing category
ANDA
Marketing start
2013-09-17
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
45802-562-01Clindamycin Phosphate30 mL in 1 BOTTLE, WITH APPLICATORSOLUTION3014
45802-562-01Clindamycin Phosphate1 in 1 CARTONSOLUTION114
45802-562-02Clindamycin Phosphate60 mL in 1 BOTTLE, WITH APPLICATORSOLUTION6014
45802-562-02Clindamycin Phosphate1 in 1 CARTONSOLUTION114
45802-562-30Clindamycin Phosphate30 mL in 1 BOTTLE, WITH APPLICATORSOLUTION3014
45802-562-60Clindamycin Phosphate60 mL in 1 BOTTLE, WITH APPLICATORSOLUTION6014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-562-01ML - Milliliter45802-562bd91b985-f7d0-4de8-9f26-f281456450f112013-10-17
45802-562-02ML - Milliliter45802-562902a4427-5e14-468f-9401-5ea07b77e7af12013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLINDAMYCIN PHOSPHATEACTIVE INGREDIENTEH6D7113I8CLINDAMYCIN PHOSPHATE SOLUTION [PERRIGO NEW YORK INC]2
CLINDAMYCINACTIVE MOIETY3U02EL437CCLINDAMYCIN PHOSPHATE SOLUTION [PERRIGO NEW YORK INC]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302CLINDAMYCIN PHOSPHATE SOLUTION [PERRIGO NEW YORK INC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CLINDAMYCIN PHOSPHATE SOLUTION [PERRIGO NEW YORK INC]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICLINDAMYCIN PHOSPHATE SOLUTION [PERRIGO NEW YORK INC]2
WATERINACTIVE INGREDIENT059QF0KO0RCLINDAMYCIN PHOSPHATE SOLUTION [PERRIGO NEW YORK INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-562CLINDAMYCIN PHOSPHATE SOLUTION [PADAGIS ISRAEL PHARMACEUTICALS LTD]12Current NDC, Legacy NDC, 6 package rows20220623_461ab478-3cf6-4e9b-ba7d-0331b379cacf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309333clindamycin phosphate 1 % Topical SolutionPSNc22fb382-afbc-4b2d-bdce-e97e21bddb23111
309333clindamycin phosphate 1 % Topical SolutionPSN27747e01-85eb-44de-a4a6-711a7799218a111
309333clindamycin 10 MG/ML Topical SolutionSCD27747e01-85eb-44de-a4a6-711a7799218a111
309333clindamycin 10 MG/ML Topical SolutionSCDc22fb382-afbc-4b2d-bdce-e97e21bddb23111
309333clindamycin (as clindamycin phosphate) 1 % Topical SolutionSY27747e01-85eb-44de-a4a6-711a7799218a111
309333clindamycin (as clindamycin phosphate) 1 % Topical SolutionSYc22fb382-afbc-4b2d-bdce-e97e21bddb23111
309333clindamycin 1 % Topical SolutionSYc22fb382-afbc-4b2d-bdce-e97e21bddb23111
309333clindamycin 1 % Topical SolutionSY27747e01-85eb-44de-a4a6-711a7799218a111
309333clindamycin phosphate 1 % Topical SolutionPSN34f7a271-c012-6463-e063-6394a90ad1ea101
309333clindamycin 10 MG/ML Topical SolutionSCD34f7a271-c012-6463-e063-6394a90ad1ea101
309333clindamycin (as clindamycin phosphate) 1 % Topical SolutionSY34f7a271-c012-6463-e063-6394a90ad1ea101
309333clindamycin 1 % Topical SolutionSY34f7a271-c012-6463-e063-6394a90ad1ea101
309333clindamycin phosphate 1 % Topical SolutionPSN25706fd8-d5e2-488b-9888-ee76d2686e19100
309333clindamycin phosphate 1 % Topical SolutionPSN576fbdf8-b44d-49bf-a569-601861cc402d100
309333clindamycin 10 MG/ML Topical SolutionSCD25706fd8-d5e2-488b-9888-ee76d2686e19100
309333clindamycin 10 MG/ML Topical SolutionSCD576fbdf8-b44d-49bf-a569-601861cc402d100
309333clindamycin (as clindamycin phosphate) 1 % Topical SolutionSY25706fd8-d5e2-488b-9888-ee76d2686e19100
309333clindamycin (as clindamycin phosphate) 1 % Topical SolutionSY576fbdf8-b44d-49bf-a569-601861cc402d100
309333clindamycin 1 % Topical SolutionSY25706fd8-d5e2-488b-9888-ee76d2686e19100
309333clindamycin 1 % Topical SolutionSY576fbdf8-b44d-49bf-a569-601861cc402d100
309333clindamycin phosphate 1 % Topical SolutionPSNba3f54e5-1ff5-4ffd-8ed2-f15439f423e915
309333clindamycin 10 MG/ML Topical SolutionSCDba3f54e5-1ff5-4ffd-8ed2-f15439f423e915
309333clindamycin (as clindamycin phosphate) 1 % Topical SolutionSYba3f54e5-1ff5-4ffd-8ed2-f15439f423e915
309333clindamycin 1 % Topical SolutionSYba3f54e5-1ff5-4ffd-8ed2-f15439f423e915
309333clindamycin phosphate 1 % Topical SolutionPSN461ab478-3cf6-4e9b-ba7d-0331b379cacf14
309333clindamycin 10 MG/ML Topical SolutionSCD461ab478-3cf6-4e9b-ba7d-0331b379cacf14
309333clindamycin (as clindamycin phosphate) 1 % Topical SolutionSY461ab478-3cf6-4e9b-ba7d-0331b379cacf14
309333clindamycin 1 % Topical SolutionSY461ab478-3cf6-4e9b-ba7d-0331b379cacf14
309333clindamycin phosphate 1 % Topical SolutionPSNeb1c0b65-391b-493e-864b-ac231da1e3f75
309333clindamycin 10 MG/ML Topical SolutionSCDeb1c0b65-391b-493e-864b-ac231da1e3f75
309333clindamycin (as clindamycin phosphate) 1 % Topical SolutionSYeb1c0b65-391b-493e-864b-ac231da1e3f75
309333clindamycin 1 % Topical SolutionSYeb1c0b65-391b-493e-864b-ac231da1e3f75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-562-01458020562011 BOTTLE, WITH APPLICATOR in 1 CARTON (45802-562-01) / 30 mL in 1 BOTTLE, WITH APPLICATOR2013-09-170000-00-00NoNoCurrent
45802-562-02458020562021 BOTTLE, WITH APPLICATOR in 1 CARTON (45802-562-02) / 60 mL in 1 BOTTLE, WITH APPLICATOR2013-09-170000-00-00NoNoCurrent
45802-562-304580205623030 mL in 1 BOTTLE, WITH APPLICATOR (45802-562-30) 30 ml2026-04-28NoNoHistorical
45802-562-604580205626060 mL in 1 BOTTLE, WITH APPLICATOR (45802-562-60) 60 ml2026-04-28NoNoHistorical