FDA.reportPublic FDA data

Clindamycin hydrochloride

Product NDC
67046-083
11-digit product format
670460083
Labeler code
67046
Product ID
67046-083_599eccbe-804c-827d-e053-2991aa0a001a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA065061
Marketing category
ANDA
Marketing start
2017-09-20
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
2020-12-31
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
67046-083-072022-01-28C16284748780-1d6a99b39-82a5-a426-e053-dadaa90af4c2CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP 083 Rx only
67046-083-142022-01-28C16284748780-1d6a99b39-82a5-a426-e053-dadaa90af4c2CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP 083 Rx only
67046-083-152022-01-28C16284748780-1d6a99b39-82a5-a426-e053-dadaa90af4c2CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP 083 Rx only
67046-083-202022-01-28C16284748780-1d6a99b39-82a5-a426-e053-dadaa90af4c2CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP 083 Rx only
67046-083-212022-01-28C16284748780-1d6a99b39-82a5-a426-e053-dadaa90af4c2CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP 083 Rx only
67046-083-282022-01-28C16284748780-1d6a99b39-82a5-a426-e053-dadaa90af4c2CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP 083 Rx only
67046-083-302022-01-28C16284748780-1d6a99b39-82a5-a426-e053-dadaa90af4c2CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP 083 Rx only
67046-083-602022-01-28C16284748780-1d6a99b39-82a5-a426-e053-dadaa90af4c2CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP 083 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-083-07Clindamycin hydrochloride7 in 1 BLISTER PACKCAPSULE71
67046-083-14Clindamycin hydrochloride14 in 1 BLISTER PACKCAPSULE141
67046-083-15Clindamycin hydrochloride15 in 1 BLISTER PACKCAPSULE151
67046-083-20Clindamycin hydrochloride20 in 1 BLISTER PACKCAPSULE201
67046-083-21Clindamycin hydrochloride21 in 1 BLISTER PACKCAPSULE211
67046-083-28Clindamycin hydrochloride28 in 1 BLISTER PACKCAPSULE281
67046-083-30Clindamycin hydrochloride30 in 1 BLISTER PACKCAPSULE301
67046-083-60Clindamycin hydrochloride60 in 1 BLISTER PACKCAPSULE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-083CLINDAMYCIN HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 8 package rows20170920_599eccbe-804b-827d-e053-2991aa0a001a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197518clindamycin HCl 150 MG Oral CapsulePSN599eccbe-804b-827d-e053-2991aa0a001a1
197518clindamycin 150 MG Oral CapsuleSCD599eccbe-804b-827d-e053-2991aa0a001a1
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSY599eccbe-804b-827d-e053-2991aa0a001a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67046-083-07670460083077 CAPSULE in 1 BLISTER PACK (67046-083-07) 7 capsule2017-09-200000-00-00NoNoCurrent
67046-083-146704600831414 CAPSULE in 1 BLISTER PACK (67046-083-14) 14 capsule2017-09-200000-00-00NoNoCurrent
67046-083-156704600831515 CAPSULE in 1 BLISTER PACK (67046-083-15) 15 capsule2017-09-200000-00-00NoNoCurrent
67046-083-206704600832020 CAPSULE in 1 BLISTER PACK (67046-083-20) 20 capsule2017-09-200000-00-00NoNoCurrent
67046-083-216704600832121 CAPSULE in 1 BLISTER PACK (67046-083-21) 21 capsule2017-09-200000-00-00NoNoCurrent
67046-083-286704600832828 CAPSULE in 1 BLISTER PACK (67046-083-28) 28 capsule2017-09-200000-00-00NoNoCurrent
67046-083-306704600833030 CAPSULE in 1 BLISTER PACK (67046-083-30) 30 capsule2017-09-200000-00-00NoNoCurrent
67046-083-606704600836060 CAPSULE in 1 BLISTER PACK (67046-083-60) 60 capsule2017-09-200000-00-00NoNoCurrent