FDA.reportPublic FDA data

Clindamycin phosphate and benzoyl peroxide

Product NDC
0591-3916
11-digit product format
005913916
Labeler code
0591
Product ID
0591-3916_c2dcadb5-8ef3-4c6a-af4f-bf201184a6d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin phosphate and benzoyl peroxide
Dosage form
GEL
Route
TOPICAL
Labeler
Actavis Pharma, Inc.
Application
ANDA205128
Marketing category
ANDA
Marketing start
2019-02-19
Marketing end
2026-06-30
Substance
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
Active strength
25; 10 mg/g; mg/g
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clindamycin phosphate and benzoyl peroxide

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOYL PEROXIDE25 mg/g
CLINDAMYCIN PHOSPHATE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW9WZN9A0GM, EH6D7113I8
Rxcui885131

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
0591-3916-68Clindamycin phosphate and benzoyl peroxide50 g in 1 BOTTLE, PUMPGEL5010
0591-3916-68Clindamycin phosphate and benzoyl peroxide1 in 1 CARTONGEL110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-3916-68GM - Gram0591-3916bdb70023-c33f-407e-aac2-beb9dd99db0b12019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-3916CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE GEL [ACTAVIS PHARMA, INC.]9Current NDC, Legacy NDC, 2 package rows20240827_87622142-000b-460b-977e-92d6735f5337.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
885131clindamycin phosphate 1.2 % / benzoyl peroxide 2.5 % Topical GelPSN87622142-000b-460b-977e-92d6735f533710
885131benzoyl peroxide 0.025 MG/MG / clindamycin phosphate 0.012 MG/MG Topical GelSCD87622142-000b-460b-977e-92d6735f533710
885131benzoyl peroxide 2.5 % / clindamycin phosphate 1.2 % Topical GelSY87622142-000b-460b-977e-92d6735f533710

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0591-3916-68005913916681 BOTTLE, PUMP in 1 CARTON (0591-3916-68) / 50 g in 1 BOTTLE, PUMP2019-02-192026-06-30NoNoCurrent