Clindamycin Palmitate Hydrochloride (Pediatric)

Product NDC
65862-596
11-digit product format
658620596
Labeler code
65862
Product ID
65862-596_78e0ae1e-9c06-4831-b962-e1aa65546110
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin Palmitate Hydrochloride (Pediatric)
Dosage form
SOLUTION
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA202409
Marketing category
ANDA
Marketing start
2013-04-30
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 (Pediatric)
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVN9A8JM7M7
Rxcui562266

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
65862-596-01Clindamycin Palmitate Hydrochloride (Pediatric)1 in 1 CARTONSOLUTION113
65862-596-01Clindamycin Palmitate Hydrochloride (Pediatric)100 mL in 1 BOTTLESOLUTION10013
65862-596-02Clindamycin Palmitate Hydrochloride (Pediatric)100 mL in 1 BOTTLE, PLASTICSOLUTION10013
65862-596-02Clindamycin Palmitate Hydrochloride (Pediatric)1 in 1 CARTONSOLUTION113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-596-01ML - Milliliter65862-596a81a561d-38d3-4021-b660-f387ea1c592912013-09-04
65862-596-02ML - Milliliter65862-5962f8772dc-beb8-47f2-88fd-64c4f5c4f50e12023-10-16

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-596CLINDAMYCIN PALMITATE HYDROCHLORIDE (PEDIATRIC) SOLUTION [AUROBINDO PHARMA LIMITED]13Current NDC, Legacy NDC, 4 package rows20240110_0bfe1e25-f0a1-4e11-9827-82912557c46b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562266clindamycin palmitate HCl 75 MG in 5 mL Oral SolutionPSN0bfe1e25-f0a1-4e11-9827-82912557c46b13
562266clindamycin 15 MG/ML Oral SolutionSCD0bfe1e25-f0a1-4e11-9827-82912557c46b13
562266clindamycin (as clindamycin palmitate HCl) 15 MG/ML Oral SolutionSY0bfe1e25-f0a1-4e11-9827-82912557c46b13
562266clindamycin 75 MG per 5 ML Powder for Oral SolutionSY0bfe1e25-f0a1-4e11-9827-82912557c46b13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-596-01658620596011 BOTTLE in 1 CARTON (65862-596-01) / 100 mL in 1 BOTTLE1 bottle2013-04-300000-00-00NoNoCurrent
65862-596-02658620596021 BOTTLE, PLASTIC in 1 CARTON (65862-596-02) / 100 mL in 1 BOTTLE, PLASTIC2022-11-14NoNoHistorical