FDA.reportPublic FDA data

Clindamycin Phosphate

Product NDC
69238-2031
11-digit product format
692382031
Labeler code
69238
Product ID
69238-2031_e3ac80f9-e1cc-4e37-bc97-f3ee4cd928e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin Phosphate
Dosage form
GEL
Route
TOPICAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA214668
Marketing category
ANDA
Marketing start
2022-08-08
Substance
CLINDAMYCIN PHOSPHATE
Active strength
1 g/100mL
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
Clindamycin Phosphate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLINDAMYCIN PHOSPHATE1 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEH6D7113I8
Rxcui309332

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
69238-2031-7Clindamycin Phosphate75 mL in 1 BOTTLEGEL758
69238-2031-7Clindamycin Phosphate1 in 1 CARTONGEL18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-2031-7ML - Milliliter69238-2031227b0b55-1e09-4fab-bd45-f320179579d012022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-2031CLINDAMYCIN PHOSPHATE GEL [AMNEAL PHARMACEUTICALS NY LLC]8Current NDC, Legacy NDC, 2 package rows20240606_ea1d4a37-7da2-4228-8451-6367e1a62554.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309332clindamycin phosphate 1 % Once-Daily Topical GelPSNea1d4a37-7da2-4228-8451-6367e1a625548
309332Once-Daily clindamycin 0.01 MG/MG Topical GelSCDea1d4a37-7da2-4228-8451-6367e1a625548
309332clindamycin (as clindamycin phosphate) 1 % Once-Daily Topical GelSYea1d4a37-7da2-4228-8451-6367e1a625548
309332clindamycin 1 % Once-Daily Topical GelSYea1d4a37-7da2-4228-8451-6367e1a625548

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-2031-7692382031071 BOTTLE in 1 CARTON (69238-2031-7) / 75 mL in 1 BOTTLE1 bottle2022-08-080000-00-00NoNoCurrent