FDA.reportPublic FDA data

Clindamycin Phosphate

Product NDC
80005-131
11-digit product format
800050131
Labeler code
80005
Product ID
80005-131_afc7cc5c-76c8-4807-82c2-765f51bdacd3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin Phosphate Topical
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Carnegie Pharmaceuticals, LLC
Application
ANDA219612
Marketing category
ANDA
Marketing start
2025-06-16
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
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
80005-131-09Clindamycin Phosphate1 mL in 1 APPLICATORSOLUTION13
80005-131-09Clindamycin Phosphate60 in 1 JARSOLUTION603
80005-131-38Clindamycin Phosphate69 in 1 JARSOLUTION693
80005-131-38Clindamycin Phosphate1 mL in 1 APPLICATORSOLUTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80005-131-09EA - Each80005-131b9844ca4-3f37-4c3e-b941-7d7b99778d1712025-07-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309333clindamycin phosphate 1 % Topical SolutionPSNc8fe61f1-f3c5-4452-9980-a727461b98443
309333clindamycin 10 MG/ML Topical SolutionSCDc8fe61f1-f3c5-4452-9980-a727461b98443
309333clindamycin (as clindamycin phosphate) 1 % Topical SolutionSYc8fe61f1-f3c5-4452-9980-a727461b98443
309333clindamycin 1 % Topical SolutionSYc8fe61f1-f3c5-4452-9980-a727461b98443

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80005-131-098000501310960 APPLICATOR in 1 JAR (80005-131-09) / 1 mL in 1 APPLICATOR60 applicator2025-06-16NoNoCurrent
80005-131-388000501313869 APPLICATOR in 1 JAR (80005-131-38) / 1 mL in 1 APPLICATOR69 applicator2025-12-15NoNoCurrent