FDA.reportPublic FDA data

CLINDAMYCIN AND BENZOYL PEROXIDE

Product NDC
45802-507
11-digit product format
458020507
Labeler code
45802
Product ID
45802-507_3d75ed15-f8a8-4317-b949-992be4c2a7bd
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
2015-09-22
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
Rxcui308694, 358917

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
45802-507-02CLINDAMYCIN AND BENZOYL PEROXIDE1 in 1 CARTONKIT15
45802-507-04clindamycin and benzoyl peroxide1 in 1 CARTONKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-507CLINDAMYCIN AND BENZOYL PEROXIDE KIT [PADAGIS ISRAEL PHARMACEUTICALS LTD]5Current NDC, Legacy NDC, 1 package rows20231011_9cba4e83-64b0-43b6-a337-cd0fd4744d31.zip
45802-507CLINDAMYCIN AND BENZOYL PEROXIDE KIT [PADAGIS ISRAEL PHARMACEUTICALS LTD]3Current NDC, Legacy NDC, 1 package rows20231011_1144d82f-085c-45a4-b32d-9b24c495d154.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308694benzoyl peroxide 5 % Topical GelPSN30d311b4-9058-4ebf-898e-17ba66294500100
358917clindamycin phosphate 1 % / benzoyl peroxide 5 % Topical GelPSN30d311b4-9058-4ebf-898e-17ba66294500100
358917benzoyl peroxide 0.05 MG/MG / clindamycin 0.01 MG/MG Topical GelSCD30d311b4-9058-4ebf-898e-17ba66294500100
308694benzoyl peroxide 0.05 MG/MG Topical GelSCD30d311b4-9058-4ebf-898e-17ba66294500100
358917benzoyl peroxide 5 % / clindamycin 1 % (as clindamycin phosphate 1.2 % ) Topical GelSY30d311b4-9058-4ebf-898e-17ba66294500100
358917benzoyl peroxide 5 % / clindamycin 1 % Topical GelSY30d311b4-9058-4ebf-898e-17ba66294500100
308694benzoyl peroxide 5 % Topical GelSY30d311b4-9058-4ebf-898e-17ba66294500100
308694benzoyl peroxide 5 % Topical GelPSN9cba4e83-64b0-43b6-a337-cd0fd4744d315
358917clindamycin phosphate 1 % / benzoyl peroxide 5 % Topical GelPSN9cba4e83-64b0-43b6-a337-cd0fd4744d315
358917benzoyl peroxide 0.05 MG/MG / clindamycin 0.01 MG/MG Topical GelSCD9cba4e83-64b0-43b6-a337-cd0fd4744d315
308694benzoyl peroxide 0.05 MG/MG Topical GelSCD9cba4e83-64b0-43b6-a337-cd0fd4744d315
358917benzoyl peroxide 5 % / clindamycin 1 % (as clindamycin phosphate 1.2 % ) Topical GelSY9cba4e83-64b0-43b6-a337-cd0fd4744d315
358917benzoyl peroxide 5 % / clindamycin 1 % Topical GelSY9cba4e83-64b0-43b6-a337-cd0fd4744d315
308694benzoyl peroxide 5 % Topical GelSY9cba4e83-64b0-43b6-a337-cd0fd4744d315
308694benzoyl peroxide 5 % Topical GelPSN1144d82f-085c-45a4-b32d-9b24c495d1543
358917clindamycin phosphate 1 % / benzoyl peroxide 5 % Topical GelPSN1144d82f-085c-45a4-b32d-9b24c495d1543
309333clindamycin phosphate 1 % Topical SolutionPSN1144d82f-085c-45a4-b32d-9b24c495d1543
358917benzoyl peroxide 0.05 MG/MG / clindamycin 0.01 MG/MG Topical GelSCD1144d82f-085c-45a4-b32d-9b24c495d1543
308694benzoyl peroxide 0.05 MG/MG Topical GelSCD1144d82f-085c-45a4-b32d-9b24c495d1543
309333clindamycin 10 MG/ML Topical SolutionSCD1144d82f-085c-45a4-b32d-9b24c495d1543
358917benzoyl peroxide 5 % / clindamycin 1 % (as clindamycin phosphate 1.2 % ) Topical GelSY1144d82f-085c-45a4-b32d-9b24c495d1543
358917benzoyl peroxide 5 % / clindamycin 1 % Topical GelSY1144d82f-085c-45a4-b32d-9b24c495d1543
308694benzoyl peroxide 5 % Topical GelSY1144d82f-085c-45a4-b32d-9b24c495d1543
309333clindamycin (as clindamycin phosphate) 1 % Topical SolutionSY1144d82f-085c-45a4-b32d-9b24c495d1543
309333clindamycin 1 % Topical SolutionSY1144d82f-085c-45a4-b32d-9b24c495d1543

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-507-01458020507011 KIT in 1 CARTON (45802-507-01) * .3 g in 1 VIAL * 19.7 g in 1 JAR1 kit2015-09-220000-00-00NoNoCurrent
45802-507-02458020507021 KIT in 1 CARTON (45802-507-02) * .6 g in 1 VIAL * 39.4 g in 1 JAR1 kit2015-09-220000-00-00NoNoCurrent
45802-507-03458020507031 KIT in 1 CARTON (45802-507-03) * .4 g in 1 VIAL * 27.6 g in 1 BOTTLE, PUMP1 kit2016-05-050000-00-00NoNoCurrent
45802-507-04458020507041 KIT in 1 CARTON (45802-507-04) * .6 g in 1 VIAL * 39.4 g in 1 BOTTLE, PUMP1 kit2016-04-260000-00-00NoNoCurrent