FDA.reportPublic FDA data

clindamycin and benzoyl peroxide

Product NDC
45802-510
11-digit product format
458020510
Labeler code
45802
Product ID
45802-510_84f65326-838e-412d-a5b4-44a28cea1415
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clindamycin and benzoyl peroxide
Dosage form
KIT
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA202440
Marketing category
ANDA
Marketing start
2021-03-08
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
clindamycin and benzoyl peroxide
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui358917

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
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
e3af9708-3004-7392-4046-5311eaa8bab5Product name320221128
ffb4bacf-f636-0f7d-0b0d-7a4b151243e3Product name920220928
b72227d6-0388-43bd-995b-b762d2754cd5Product name120220706
a92d22e0-3af4-f301-bc88-27ff030b0070Product name220220316
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
5ce6ce33-4f2b-3ce0-757d-e520013280cfProduct name520180719
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
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
45802-510-03clindamycin and benzoyl peroxide1 in 1 CARTONKIT14
45802-738-03clindamycin and benzoyl peroxide0.4 g in 1 VIALPOWDER, FOR SOLUTION0.4 g10 mg in 1g4
45802-998-03clindamycin and benzoyl peroxide27.6 g in 1 BOTTLE, PUMPGEL27.6 g50 mg in 1g4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-510-03GM - Gram45802-510496b0945-e7a0-458b-bc39-f6248cf1a07012021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-510CLINDAMYCIN AND BENZOYL PEROXIDE KIT [PADAGIS ISRAEL PHARMACEUTICALS LTD]4Current NDC, Legacy NDC, 3 package rows20231011_6bf0f3e5-6ad7-4791-9483-0977b18ad77f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
358917clindamycin phosphate 1 % / benzoyl peroxide 5 % Topical GelPSN6bf0f3e5-6ad7-4791-9483-0977b18ad77f4
358917benzoyl peroxide 0.05 MG/MG / clindamycin 0.01 MG/MG Topical GelSCD6bf0f3e5-6ad7-4791-9483-0977b18ad77f4
358917benzoyl peroxide 5 % / clindamycin 1 % (as clindamycin phosphate 1.2 % ) Topical GelSY6bf0f3e5-6ad7-4791-9483-0977b18ad77f4
358917benzoyl peroxide 5 % / clindamycin 1 % Topical GelSY6bf0f3e5-6ad7-4791-9483-0977b18ad77f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-510-03458020510031 KIT in 1 CARTON (45802-510-03) * .4 g in 1 VIAL (45802-738-03) * 27.6 g in 1 BOTTLE, PUMP (45802-998-03) 1 kit2021-03-080000-00-00NoNoCurrent
45802-738-03458020738030.4 g in 1 VIAL0.4 gHistorical
45802-998-034580209980327.6 g in 1 BOTTLE, PUMP27.6 gHistorical