FDA.reportPublic FDA data

Clindamycin Phosphate

Product NDC
68462-605
11-digit product format
684620605
Labeler code
68462
Product ID
68462-605_65e63c9a-9be2-43c3-bbab-4b03df80e3a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin Phosphate
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
GLENMARK PHARMACEUTICALS INC., USA
Application
ANDA210778
Marketing category
ANDA
Marketing start
2024-01-23
Substance
CLINDAMYCIN PHOSPHATE
Active strength
10 mg/g
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/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEH6D7113I8
Rxcui477451

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
68462-605-27Clindamycin Phosphate50 g in 1 CANAEROSOL, FOAM502
68462-605-27Clindamycin Phosphate1 in 1 CARTONAEROSOL, FOAM12
68462-605-94Clindamycin Phosphate1 in 1 CARTONAEROSOL, FOAM12
68462-605-94Clindamycin Phosphate100 g in 1 CANAEROSOL, FOAM1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-605-27GM - Gram68462-605ef3676c1-23d9-48ed-bf35-d523f77474af12025-03-04
68462-605-94GM - Gram68462-605859c3609-902f-4d59-b633-7705cac448bc12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-605CLINDAMYCIN PHOSPHATE AEROSOL, FOAM [GLENMARK PHARMACEUTICALS INC., USA]1Current NDC, 4 package rows20240208_d0ec3e88-40d9-4919-afc3-cf2e7e863376.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477451clindamycin phosphate 1 % Topical FoamPSNd0ec3e88-40d9-4919-afc3-cf2e7e8633762
477451clindamycin 10 MG/ML Topical FoamSCDd0ec3e88-40d9-4919-afc3-cf2e7e8633762
477451clindamycin (as clindamycin phosphate) 1 % Topical FoamSYd0ec3e88-40d9-4919-afc3-cf2e7e8633762
477451clindamycin 1 % Topical FoamSYd0ec3e88-40d9-4919-afc3-cf2e7e8633762

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68462-605-27684620605271 CAN in 1 CARTON (68462-605-27) / 50 g in 1 CAN1 can2024-01-23NoNoHistorical
68462-605-94684620605941 CAN in 1 CARTON (68462-605-94) / 100 g in 1 CAN1 can2024-01-23NoNoHistorical