FDA.reportPublic FDA data

Clindamycin Phosphate

Product NDC
45802-660
11-digit product format
458020660
Labeler code
45802
Product ID
45802-660_5c4e6dd8-1cba-471e-ae54-220717472f41
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clindamycin phosphate
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA090785
Marketing category
ANDA
Marketing start
2010-03-31
Substance
CLINDAMYCIN PHOSPHATE
Active strength
10 mg/g
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clindamycin Phosphate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLINDAMYCIN PHOSPHATE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEH6D7113I8
Rxcui477451

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
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
45802-660-32Clindamycin Phosphate1 in 1 CARTONAEROSOL, FOAM112
45802-660-32Clindamycin Phosphate50 g in 1 CANAEROSOL, FOAM5012
45802-660-33Clindamycin Phosphate100 g in 1 CANAEROSOL, FOAM10012
45802-660-33Clindamycin Phosphate1 in 1 CARTONAEROSOL, FOAM112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-660-32GM - Gram45802-660f14bf9a6-7d1f-4a17-bcba-ec6ca2f8591c12012-07-24
45802-660-33GM - Gram45802-66007e2ca88-83ee-4d43-bcbb-9611d88b9ba912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLINDAMYCIN PHOSPHATEACTIVE INGREDIENTEH6D7113I8CLINDAMYCIN PHOSPHATE AEROSOL, FOAM [PERRIGO NEW YORK INC]8
CLINDAMYCINACTIVE MOIETY3U02EL437CCLINDAMYCIN PHOSPHATE AEROSOL, FOAM [PERRIGO NEW YORK INC]8
ALCOHOLINACTIVE INGREDIENT3K9958V90MCLINDAMYCIN PHOSPHATE AEROSOL, FOAM [PERRIGO NEW YORK INC]8
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNCLINDAMYCIN PHOSPHATE AEROSOL, FOAM [PERRIGO NEW YORK INC]8
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MCLINDAMYCIN PHOSPHATE AEROSOL, FOAM [PERRIGO NEW YORK INC]8
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CLINDAMYCIN PHOSPHATE AEROSOL, FOAM [PERRIGO NEW YORK INC]8
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YCLINDAMYCIN PHOSPHATE AEROSOL, FOAM [PERRIGO NEW YORK INC]8
WATERINACTIVE INGREDIENT059QF0KO0RCLINDAMYCIN PHOSPHATE AEROSOL, FOAM [PERRIGO NEW YORK INC]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-660CLINDAMYCIN PHOSPHATE AEROSOL, FOAM [PADAGIS ISRAEL PHARMACEUTICALS LTD]12Current NDC, Legacy NDC, 4 package rows20220414_2e6f96d0-d928-4775-a7db-3e998fce675b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477451clindamycin phosphate 1 % Topical FoamPSNa95020e2-9318-4a6b-8931-95771946638d103
477451clindamycin phosphate 1 % Topical FoamPSNe8086cf9-aa52-4aa5-815b-c76e8f145e0b103
477451clindamycin 10 MG/ML Topical FoamSCDa95020e2-9318-4a6b-8931-95771946638d103
477451clindamycin 10 MG/ML Topical FoamSCDe8086cf9-aa52-4aa5-815b-c76e8f145e0b103
477451clindamycin (as clindamycin phosphate) 1 % Topical FoamSYa95020e2-9318-4a6b-8931-95771946638d103
477451clindamycin (as clindamycin phosphate) 1 % Topical FoamSYe8086cf9-aa52-4aa5-815b-c76e8f145e0b103
477451clindamycin 1 % Topical FoamSYa95020e2-9318-4a6b-8931-95771946638d103
477451clindamycin 1 % Topical FoamSYe8086cf9-aa52-4aa5-815b-c76e8f145e0b103
477451clindamycin phosphate 1 % Topical FoamPSN2e6f96d0-d928-4775-a7db-3e998fce675b12
477451clindamycin 10 MG/ML Topical FoamSCD2e6f96d0-d928-4775-a7db-3e998fce675b12
477451clindamycin (as clindamycin phosphate) 1 % Topical FoamSY2e6f96d0-d928-4775-a7db-3e998fce675b12
477451clindamycin 1 % Topical FoamSY2e6f96d0-d928-4775-a7db-3e998fce675b12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-660-32458020660321 CAN in 1 CARTON (45802-660-32) / 50 g in 1 CAN1 can2010-03-310000-00-00NoNoCurrent
45802-660-33458020660331 CAN in 1 CARTON (45802-660-33) / 100 g in 1 CAN1 can2010-03-310000-00-00NoNoCurrent