FDA.reportPublic FDA data

Clindacin P

Product NDC
43538-170
11-digit product format
435380170
Labeler code
43538
Product ID
43538-170_46465f9a-1b07-4044-9598-55a211b95297
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clindamycin phosphate
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Medimetriks Pharmaceuticals, Inc.
Application
ANDA065049
Marketing category
ANDA
Marketing start
2011-02-20
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clindacin P
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLINDAMYCIN PHOSPHATE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEH6D7113I8

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
43538-170-69Clindacin P1 mL in 1 APPLICATORSOLUTION15
43538-170-69Clindacin P69 in 1 JARSOLUTION695

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43538-170-69EA - Each43538-1709c483554-e1c1-4b98-9d8e-94930e621e2712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
clindamycin phosphateACTIVE INGREDIENTEH6D7113I8CLINDACIN P (CLINDAMYCIN PHOSPHATE) SWAB CLINDACIN PAC (CLINDAMYCIN PHOSPHATE) SWAB [MEDIMETRIKS PHARMACEUTICALS, INC.]1
clindamycinACTIVE MOIETY3U02EL437CCLINDACIN P (CLINDAMYCIN PHOSPHATE) SWAB CLINDACIN PAC (CLINDAMYCIN PHOSPHATE) SWAB [MEDIMETRIKS PHARMACEUTICALS, INC.]1
isopropyl alcoholINACTIVE INGREDIENTND2M416302CLINDACIN P (CLINDAMYCIN PHOSPHATE) SWAB CLINDACIN PAC (CLINDAMYCIN PHOSPHATE) SWAB [MEDIMETRIKS PHARMACEUTICALS, INC.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CLINDACIN P (CLINDAMYCIN PHOSPHATE) SWAB CLINDACIN PAC (CLINDAMYCIN PHOSPHATE) SWAB [MEDIMETRIKS PHARMACEUTICALS, INC.]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32ICLINDACIN P (CLINDAMYCIN PHOSPHATE) SWAB CLINDACIN PAC (CLINDAMYCIN PHOSPHATE) SWAB [MEDIMETRIKS PHARMACEUTICALS, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RCLINDACIN P (CLINDAMYCIN PHOSPHATE) SWAB CLINDACIN PAC (CLINDAMYCIN PHOSPHATE) SWAB [MEDIMETRIKS PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43538-170CLINDACIN P (CLINDAMYCIN PHOSPHATE) SOLUTION CLINDACIN PAC (CLINDAMYCIN PHOSPHATE) SWAB [MEDIMETRIKS PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 2 package rows20231116_288371ef-96b6-4ce3-9be1-1d9d309b400c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1091339Clindacin Pledget 1 % Medicated PadPSN288371ef-96b6-4ce3-9be1-1d9d309b400c5
797274clindamycin 1 % Medicated PadPSN288371ef-96b6-4ce3-9be1-1d9d309b400c5
309333clindamycin phosphate 1 % Topical SolutionPSN288371ef-96b6-4ce3-9be1-1d9d309b400c5
1091339clindamycin 10 MG/ML Medicated Pad [Clindacin]SBD288371ef-96b6-4ce3-9be1-1d9d309b400c5
797274clindamycin 10 MG/ML Medicated PadSCD288371ef-96b6-4ce3-9be1-1d9d309b400c5
309333clindamycin 10 MG/ML Topical SolutionSCD288371ef-96b6-4ce3-9be1-1d9d309b400c5
1091339Clindacin 10 MG/ML Medicated PadSY288371ef-96b6-4ce3-9be1-1d9d309b400c5
1091339Clindacin ETZ (as clindamycin phosphate) 1 % Medicated PadSY288371ef-96b6-4ce3-9be1-1d9d309b400c5
1091339Clindacin P (as clindamycin phosphate) 1 % Medicated PadSY288371ef-96b6-4ce3-9be1-1d9d309b400c5
1091339Clindacin P 1 % Topical SwabSY288371ef-96b6-4ce3-9be1-1d9d309b400c5
309333clindamycin (as clindamycin phosphate) 1 % Topical SolutionSY288371ef-96b6-4ce3-9be1-1d9d309b400c5
797274clindamycin (as clindamycin phosphate) 10 MG/ML Medicated PadSY288371ef-96b6-4ce3-9be1-1d9d309b400c5
797274clindamycin 1 % Medicated PadSY288371ef-96b6-4ce3-9be1-1d9d309b400c5
309333clindamycin 1 % Topical SolutionSY288371ef-96b6-4ce3-9be1-1d9d309b400c5
797274clindamycin 1 % Topical SwabSY288371ef-96b6-4ce3-9be1-1d9d309b400c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43538-170-694353801706969 APPLICATOR in 1 JAR (43538-170-69) / 1 mL in 1 APPLICATOR69 applicator2022-11-140000-00-00NoNoCurrent