FDA.reportPublic FDA data

Clindamycin Hydrochloride

Product NDC
67046-084
11-digit product format
670460084
Labeler code
67046
Product ID
67046-084_49a643c3-14ef-4bfd-bb66-be05e1696c7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA063083
Marketing category
ANDA
Marketing start
2010-08-09
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
E
Listing certified through
2017-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67046-084-102019-10-21C16284748780-1956f9ecf-d9f2-621f-e053-dbdaa90a74adClindamycin Hydrochloride Capsules USP
67046-084-202019-10-21C16284748780-1956f9ecf-d9f2-621f-e053-dbdaa90a74adClindamycin Hydrochloride Capsules USP
67046-084-212019-10-21C16284748780-1956f9ecf-d9f2-621f-e053-dbdaa90a74adClindamycin Hydrochloride Capsules USP
67046-084-282019-10-21C16284748780-1956f9ecf-d9f2-621f-e053-dbdaa90a74adClindamycin Hydrochloride Capsules USP
67046-084-302019-10-21C16284748780-1956f9ecf-d9f2-621f-e053-dbdaa90a74adClindamycin Hydrochloride Capsules USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-084-10Clindamycin Hydrochloride10 in 1 BLISTER PACKCAPSULE101
67046-084-20Clindamycin Hydrochloride20 in 1 BLISTER PACKCAPSULE201
67046-084-21Clindamycin Hydrochloride21 in 1 BLISTER PACKCAPSULE211
67046-084-28Clindamycin Hydrochloride28 in 1 BLISTER PACKCAPSULE281
67046-084-30Clindamycin Hydrochloride30 in 1 BLISTER PACKCAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-084CLINDAMYCIN HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 5 package rows20100810_49a643c3-14ef-4bfd-bb66-be05e1696c7e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197518clindamycin HCl 150 MG Oral CapsulePSN49a643c3-14ef-4bfd-bb66-be05e1696c7e1
197518clindamycin 150 MG Oral CapsuleSCD49a643c3-14ef-4bfd-bb66-be05e1696c7e1
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSY49a643c3-14ef-4bfd-bb66-be05e1696c7e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67046-084-106704600841010 in 1 BLISTER PACKHistorical
67046-084-206704600842020 in 1 BLISTER PACKHistorical
67046-084-216704600842121 in 1 BLISTER PACKHistorical
67046-084-286704600842828 in 1 BLISTER PACKHistorical
67046-084-306704600843030 in 1 BLISTER PACKHistorical