FDA.reportPublic FDA data

Clindamycin Palmitate Hydrochloride

Product NDC
53746-468
11-digit product format
537460468
Labeler code
53746
Product ID
53746-468_b9016023-7843-48e3-8ff6-2e5a70aa5daf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin Palmitate Hydrochloride
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA203513
Marketing category
ANDA
Marketing start
2024-04-01
Substance
CLINDAMYCIN PALMITATE HYDROCHLORIDE
Active strength
75 mg/5mL
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 Palmitate Hydrochloride
Brand name suffix
(Pediatric)
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLINDAMYCIN PALMITATE HYDROCHLORIDE75 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVN9A8JM7M7

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
53746-468-19Clindamycin Palmitate Hydrochloride(Pediatric)1 in 1 CARTONPOWDER, FOR SOLUTION12
53746-468-19Clindamycin Palmitate Hydrochloride(Pediatric)100 mL in 1 BOTTLEPOWDER, FOR SOLUTION1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53746-468-19ML - Milliliter53746-468511add72-b225-414e-89ea-04c1e15ece7b12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53746-468CLINDAMYCIN PALMITATE HYDROCHLORIDE (PEDIATRIC) (CLINDAMYCIN PALMITATE HYDROCHLORIDE) POWDER, FOR SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]2Current NDC, 2 package rows20240427_faf67eb8-1fd7-4b2c-a55b-24ba664c0dce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562266clindamycin palmitate HCl 75 MG in 5 mL Oral SolutionPSNfaf67eb8-1fd7-4b2c-a55b-24ba664c0dce2
562266clindamycin 15 MG/ML Oral SolutionSCDfaf67eb8-1fd7-4b2c-a55b-24ba664c0dce2
562266clindamycin (as clindamycin palmitate HCl) 15 MG/ML Oral SolutionSYfaf67eb8-1fd7-4b2c-a55b-24ba664c0dce2
562266clindamycin 75 MG per 5 ML Powder for Oral SolutionSYfaf67eb8-1fd7-4b2c-a55b-24ba664c0dce2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53746-468-19537460468191 BOTTLE in 1 CARTON (53746-468-19) / 100 mL in 1 BOTTLE1 bottle2024-04-01NoNoCurrent