Clindamycin Hydrochloride

Product NDC
63739-059
11-digit product format
637390059
Labeler code
63739
Product ID
63739-059_b95a76ad-9b51-692a-e053-2995a90abd1a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
McKesson Corporation dba Sky Packaging
Application
ANDA063083
Marketing category
ANDA
Marketing start
2007-08-06
Marketing end
0000-00-00
Substance
CLINDAMYCIN HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63739-059-10Clindamycin Hydrochloride100 in 1 BLISTER PACKCAPSULE1003
63739-059-10Clindamycin Hydrochloride10 in 1 BOX, UNIT-DOSECAPSULE103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-059-10EA - Each63739-0592e38f267-c2d8-40b9-8d3b-081bd789c49612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Clindamycin HydrochlorideACTIVE INGREDIENTT20OQ1YN1WCLINDAMYCIN HYDROCHLORIDE CAPSULE [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]1
ClindamycinACTIVE MOIETY3U02EL437CCLINDAMYCIN HYDROCHLORIDE CAPSULE [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCLINDAMYCIN HYDROCHLORIDE CAPSULE [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHCLINDAMYCIN HYDROCHLORIDE CAPSULE [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCLINDAMYCIN HYDROCHLORIDE CAPSULE [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACLINDAMYCIN HYDROCHLORIDE CAPSULE [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCLINDAMYCIN HYDROCHLORIDE CAPSULE [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CLINDAMYCIN HYDROCHLORIDE CAPSULE [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]1
gelatinINACTIVE INGREDIENT2G86QN327LCLINDAMYCIN HYDROCHLORIDE CAPSULE [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]1
magnesium stearateINACTIVE INGREDIENT70097M6I30CLINDAMYCIN HYDROCHLORIDE CAPSULE [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4CLINDAMYCIN HYDROCHLORIDE CAPSULE [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JCLINDAMYCIN HYDROCHLORIDE CAPSULE [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLINDAMYCIN HYDROCHLORIDE CAPSULE [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]1
talcINACTIVE INGREDIENT7SEV7J4R1UCLINDAMYCIN HYDROCHLORIDE CAPSULE [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCLINDAMYCIN HYDROCHLORIDE CAPSULE [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63739-059CLINDAMYCIN HYDROCHLORIDE CAPSULE [MCKESSON CORPORATION DBA SKY PACKAGING]3Legacy NDC, 2 package rows20210121_363d5e7d-2734-4a26-8b7c-a75a707dbaae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197518clindamycin HCl 150 MG Oral CapsulePSN363d5e7d-2734-4a26-8b7c-a75a707dbaae3
197518clindamycin 150 MG Oral CapsuleSCD363d5e7d-2734-4a26-8b7c-a75a707dbaae3
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSY363d5e7d-2734-4a26-8b7c-a75a707dbaae3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63739-059-106373900591010 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-059-10) > 100 CAPSULE in 1 BLISTER PACK10 blister pack2007-08-062021-08-31NoNoCurrent