FDA.reportPublic FDA data

Clindamycin Hydrochloride

Product NDC
67296-1760
11-digit product format
672961760
Labeler code
67296
Product ID
67296-1760_d61cbf5f-aaf8-19ff-e053-2995a90a2c00
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA065243
Marketing category
ANDA
Marketing start
2020-01-01
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], 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
67296-1760-32024-01-30C16284748780-11030e365-25de-111a-e063-dadaa90a10e2Clindamycin 150mg
67296-1760-42024-01-30C16284748780-11030e365-25de-111a-e063-dadaa90a10e2Clindamycin 150mg
67296-1760-62024-01-30C16284748780-11030e365-25de-111a-e063-dadaa90a10e2Clindamycin 150mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1760-3Clindamycin Hydrochloride30 in 1 BOTTLECAPSULE302
67296-1760-4Clindamycin Hydrochloride40 in 1 BOTTLECAPSULE402
67296-1760-6Clindamycin Hydrochloride60 in 1 BOTTLECAPSULE602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1760CLINDAMYCIN HYDROCHLORIDE CAPSULE [REDPHARM DRUG, INC.]2Legacy NDC, 3 package rows20220123_a341a3c8-9ed6-52e9-e053-2995a90a300f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197518clindamycin HCl 150 MG Oral CapsulePSNa341a3c8-9ed6-52e9-e053-2995a90a300f2
197518clindamycin 150 MG Oral CapsuleSCDa341a3c8-9ed6-52e9-e053-2995a90a300f2
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSYa341a3c8-9ed6-52e9-e053-2995a90a300f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1760-36729617600330 CAPSULE in 1 BOTTLE (67296-1760-3) 30 capsule2020-01-010000-00-00NoNoCurrent
67296-1760-46729617600440 CAPSULE in 1 BOTTLE (67296-1760-4) 40 capsule2020-01-010000-00-00NoNoCurrent
67296-1760-66729617600660 CAPSULE in 1 BOTTLE (67296-1760-6) 60 capsule2020-01-010000-00-00NoNoCurrent