FDA.reportPublic FDA data

CLINDAMYCIN PALMITATE HYDROCHLORIDE

Product NDC
64980-511
11-digit product format
649800511
Labeler code
64980
Product ID
64980-511_dbaca08e-0bce-412b-b46f-2a92bc597d8e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLINDAMYCIN PALMITATE HYDROCHLORIDE
Dosage form
GRANULE, FOR SOLUTION
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA201821
Marketing category
ANDA
Marketing start
2012-09-11
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
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
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
64980-511-10CLINDAMYCIN PALMITATE HYDROCHLORIDE(Pediatric)100 mL in 1 BOTTLEGRANULE, FOR SOLUTION1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-511-10ML - Milliliter64980-51132aa78ef-ff44-4b59-9e97-74684dc049a212013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLINDAMYCIN PALMITATE HYDROCHLORIDEACTIVE INGREDIENTVN9A8JM7M7CLINDAMYCIN PALMITATE HYDROCHLORIDE (PEDIATRIC) (CLINDAMYCIN PALMITATE HYDROCHLORIDE) GRANULE, FOR SOLUTION [RISING PHARMACEUTICALS, INC.]1
CLINDAMYCINACTIVE MOIETY3U02EL437CCLINDAMYCIN PALMITATE HYDROCHLORIDE (PEDIATRIC) (CLINDAMYCIN PALMITATE HYDROCHLORIDE) GRANULE, FOR SOLUTION [RISING PHARMACEUTICALS, INC.]1
ETHYLPARABEN, SODIUM SALTINACTIVE INGREDIENTZ0D00IVA10CLINDAMYCIN PALMITATE HYDROCHLORIDE (PEDIATRIC) (CLINDAMYCIN PALMITATE HYDROCHLORIDE) GRANULE, FOR SOLUTION [RISING PHARMACEUTICALS, INC.]1
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGCLINDAMYCIN PALMITATE HYDROCHLORIDE (PEDIATRIC) (CLINDAMYCIN PALMITATE HYDROCHLORIDE) GRANULE, FOR SOLUTION [RISING PHARMACEUTICALS, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554CLINDAMYCIN PALMITATE HYDROCHLORIDE (PEDIATRIC) (CLINDAMYCIN PALMITATE HYDROCHLORIDE) GRANULE, FOR SOLUTION [RISING PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-511CLINDAMYCIN PALMITATE HYDROCHLORIDE (PEDIATRIC) (CLINDAMYCIN PALMITATE HYDROCHLORIDE) GRANULE, FOR SOLUTION [RISING PHARMA HOLDINGS, INC.]7Current NDC, Legacy NDC, 1 package rows20250426_0800afad-e4cd-4f70-aaa1-a14547be4729.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562266clindamycin palmitate HCl 75 MG in 5 mL Oral SolutionPSN3afe52c2-b65b-40fe-b2fa-da39f1bcf529107
562266clindamycin 15 MG/ML Oral SolutionSCD3afe52c2-b65b-40fe-b2fa-da39f1bcf529107
562266clindamycin (as clindamycin palmitate HCl) 15 MG/ML Oral SolutionSY3afe52c2-b65b-40fe-b2fa-da39f1bcf529107
562266clindamycin 75 MG per 5 ML Powder for Oral SolutionSY3afe52c2-b65b-40fe-b2fa-da39f1bcf529107
562266clindamycin palmitate HCl 75 MG in 5 mL Oral SolutionPSN28ba03fd-0f9c-49c6-9bfb-cda5417801c6101
562266clindamycin 15 MG/ML Oral SolutionSCD28ba03fd-0f9c-49c6-9bfb-cda5417801c6101
562266clindamycin (as clindamycin palmitate HCl) 15 MG/ML Oral SolutionSY28ba03fd-0f9c-49c6-9bfb-cda5417801c6101
562266clindamycin 75 MG per 5 ML Powder for Oral SolutionSY28ba03fd-0f9c-49c6-9bfb-cda5417801c6101
562266clindamycin palmitate HCl 75 MG in 5 mL Oral SolutionPSN0800afad-e4cd-4f70-aaa1-a14547be47297
562266clindamycin 15 MG/ML Oral SolutionSCD0800afad-e4cd-4f70-aaa1-a14547be47297
562266clindamycin (as clindamycin palmitate HCl) 15 MG/ML Oral SolutionSY0800afad-e4cd-4f70-aaa1-a14547be47297
562266clindamycin 75 MG per 5 ML Powder for Oral SolutionSY0800afad-e4cd-4f70-aaa1-a14547be47297

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64980-511-1064980051110100 mL in 1 BOTTLE (64980-511-10) 100 ml2019-06-120000-00-00NoNoCurrent