FDA.reportPublic FDA data

CLINDAMYCIN HYDROCHLORIDE

Product NDC
53002-0622
11-digit product format
530020622
Labeler code
53002
Product ID
53002-0622_1e064952-90e5-40c6-8a74-f0ebbc3be4e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA207402
Marketing category
ANDA
Marketing start
2019-01-07
Marketing end
0000-00-00
Substance
CLINDAMYCIN HYDROCHLORIDE
Active strength
300 mg/1
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
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
53002-0622-12025-01-30C16284748780-12cef2736-66b8-d83d-e063-dadaa90ab31fClindamycin Hydrochloride Capsules, USP
53002-0622-22025-01-30C16284748780-12cef2736-66b8-d83d-e063-dadaa90ab31fClindamycin Hydrochloride Capsules, USP
53002-0622-32025-01-30C16284748780-12cef2736-66b8-d83d-e063-dadaa90ab31fClindamycin Hydrochloride Capsules, USP
53002-0622-42025-01-30C16284748780-12cef2736-66b8-d83d-e063-dadaa90ab31fClindamycin Hydrochloride Capsules, USP
53002-0622-52025-01-30C16284748780-12cef2736-66b8-d83d-e063-dadaa90ab31fClindamycin Hydrochloride Capsules, USP
53002-0622-62025-01-30C16284748780-12cef2736-66b8-d83d-e063-dadaa90ab31fClindamycin Hydrochloride Capsules, USP
53002-0622-92025-01-30C16284748780-12cef2736-66b8-d83d-e063-dadaa90ab31fClindamycin Hydrochloride Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-0622-1CLINDAMYCIN HYDROCHLORIDE10 in 1 BOTTLECAPSULE101
53002-0622-2CLINDAMYCIN HYDROCHLORIDE15 in 1 BOTTLECAPSULE151
53002-0622-3CLINDAMYCIN HYDROCHLORIDE20 in 1 BOTTLECAPSULE201
53002-0622-4CLINDAMYCIN HYDROCHLORIDE28 in 1 BOTTLECAPSULE281
53002-0622-5CLINDAMYCIN HYDROCHLORIDE30 in 1 BOTTLECAPSULE301
53002-0622-6CLINDAMYCIN HYDROCHLORIDE40 in 1 BOTTLECAPSULE401
53002-0622-9CLINDAMYCIN HYDROCHLORIDE56 in 1 BOTTLECAPSULE561

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-0622CLINDAMYCIN HYDROCHLORIDE CAPSULE [RPK PHARMACEUTICALS, INC.]1Legacy NDC, 7 package rows20220331_88e5aedb-4d84-4fda-9bc1-05f0ed12279d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284215clindamycin HCl 300 MG Oral CapsulePSN88e5aedb-4d84-4fda-9bc1-05f0ed12279d1
284215clindamycin 300 MG Oral CapsuleSCD88e5aedb-4d84-4fda-9bc1-05f0ed12279d1
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSY88e5aedb-4d84-4fda-9bc1-05f0ed12279d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-0622-15300206220110 CAPSULE in 1 BOTTLE (53002-0622-1) 10 capsule2021-01-010000-00-00NoNoCurrent
53002-0622-25300206220215 CAPSULE in 1 BOTTLE (53002-0622-2) 15 capsule2021-01-010000-00-00NoNoCurrent
53002-0622-35300206220320 CAPSULE in 1 BOTTLE (53002-0622-3) 20 capsule2021-01-010000-00-00NoNoCurrent
53002-0622-45300206220428 CAPSULE in 1 BOTTLE (53002-0622-4) 28 capsule2021-01-010000-00-00NoNoCurrent
53002-0622-55300206220530 CAPSULE in 1 BOTTLE (53002-0622-5) 30 capsule2021-01-010000-00-00NoNoCurrent
53002-0622-65300206220640 CAPSULE in 1 BOTTLE (53002-0622-6) 40 capsule2021-01-010000-00-00NoNoCurrent
53002-0622-95300206220956 CAPSULE in 1 BOTTLE (53002-0622-9) 56 capsule2021-01-010000-00-00NoNoCurrent