FDA.reportPublic FDA data

Clindamycin Hydrochloride

Product NDC
53002-2320
11-digit product format
530022320
Labeler code
53002
Product ID
53002-2320_fc0a09af-9867-40ec-b20f-434fb7c49ec8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA063083
Marketing category
ANDA
Marketing start
1991-07-31
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
2021-12-31
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
53002-2320-02023-01-30C16284748780-1f386c649-b9c7-0266-e053-dadaa90a7c1aClindamycin Hydrochloride Capsules, USP
53002-2320-12023-01-30C16284748780-1f386c649-b9c7-0266-e053-dadaa90a7c1aClindamycin Hydrochloride Capsules, USP
53002-2320-22023-01-30C16284748780-1f386c649-b9c7-0266-e053-dadaa90a7c1aClindamycin Hydrochloride Capsules, USP
53002-2320-32023-01-30C16284748780-1f386c649-b9c7-0266-e053-dadaa90a7c1aClindamycin Hydrochloride Capsules, USP
53002-2320-42023-01-30C16284748780-1f386c649-b9c7-0266-e053-dadaa90a7c1aClindamycin Hydrochloride Capsules, USP
53002-2320-52023-01-30C16284748780-1f386c649-b9c7-0266-e053-dadaa90a7c1aClindamycin Hydrochloride Capsules, USP
53002-2320-62023-01-30C16284748780-1f386c649-b9c7-0266-e053-dadaa90a7c1aClindamycin Hydrochloride Capsules, USP
53002-2320-82023-01-30C16284748780-1f386c649-b9c7-0266-e053-dadaa90a7c1aClindamycin Hydrochloride Capsules, USP
53002-2320-92023-01-30C16284748780-1f386c649-b9c7-0266-e053-dadaa90a7c1aClindamycin Hydrochloride Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-2320-0Clindamycin Hydrochloride60 in 1 BOTTLECAPSULE604
53002-2320-1Clindamycin Hydrochloride8 in 1 BOTTLECAPSULE84
53002-2320-2Clindamycin Hydrochloride20 in 1 BOTTLECAPSULE204
53002-2320-3Clindamycin Hydrochloride21 in 1 BOTTLECAPSULE214
53002-2320-4Clindamycin Hydrochloride28 in 1 BOTTLECAPSULE284
53002-2320-5Clindamycin Hydrochloride30 in 1 BOTTLECAPSULE304
53002-2320-6Clindamycin Hydrochloride40 in 1 BOTTLECAPSULE404
53002-2320-8Clindamycin Hydrochloride42 in 1 BOTTLECAPSULE424
53002-2320-9Clindamycin Hydrochloride56 in 1 BOTTLECAPSULE564

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-2320CLINDAMYCIN HYDROCHLORIDE CAPSULE [RPK PHARMACEUTICALS, INC.]4Legacy NDC, 9 package rows20201225_4703aa24-edc1-4d63-85e5-0ce85df45172.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197518clindamycin HCl 150 MG Oral CapsulePSN4703aa24-edc1-4d63-85e5-0ce85df451724
197518clindamycin 150 MG Oral CapsuleSCD4703aa24-edc1-4d63-85e5-0ce85df451724
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSY4703aa24-edc1-4d63-85e5-0ce85df451724

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-2320-05300223200060 CAPSULE in 1 BOTTLE (53002-2320-0) 60 capsule2019-01-010000-00-00NoNoCurrent
53002-2320-1530022320018 CAPSULE in 1 BOTTLE (53002-2320-1) 8 capsule2019-01-010000-00-00NoNoCurrent
53002-2320-25300223200220 CAPSULE in 1 BOTTLE (53002-2320-2) 20 capsule2019-01-010000-00-00NoNoCurrent
53002-2320-35300223200321 CAPSULE in 1 BOTTLE (53002-2320-3) 21 capsule2019-01-010000-00-00NoNoCurrent
53002-2320-45300223200428 CAPSULE in 1 BOTTLE (53002-2320-4) 28 capsule2019-01-010000-00-00NoNoCurrent
53002-2320-55300223200530 CAPSULE in 1 BOTTLE (53002-2320-5) 30 capsule2019-01-010000-00-00NoNoCurrent
53002-2320-65300223200640 CAPSULE in 1 BOTTLE (53002-2320-6) 40 capsule2019-01-010000-00-00NoNoCurrent
53002-2320-85300223200842 CAPSULE in 1 BOTTLE (53002-2320-8) 42 capsule2019-01-010000-00-00NoNoCurrent
53002-2320-95300223200956 CAPSULE in 1 BOTTLE (53002-2320-9) 56 capsule2019-01-010000-00-00NoNoCurrent