FDA.reportPublic FDA data

Clindamycin Hydrochloride

Product NDC
0591-5708
11-digit product format
005915708
Labeler code
0591
Product ID
0591-5708_2311b1c3-53ad-485b-a5e6-ac08c57ce92e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA063083
Marketing category
ANDA
Marketing start
1991-07-31
Marketing end
2022-05-31
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
0000-00-00
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197518clindamycin HCl 150 MG Oral CapsulePSN7e91d826-7c57-4644-b1a6-48924b3efe9618
284215clindamycin HCl 300 MG Oral CapsulePSN7e91d826-7c57-4644-b1a6-48924b3efe9618
197518clindamycin 150 MG Oral CapsuleSCD7e91d826-7c57-4644-b1a6-48924b3efe9618
284215clindamycin 300 MG Oral CapsuleSCD7e91d826-7c57-4644-b1a6-48924b3efe9618
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSY7e91d826-7c57-4644-b1a6-48924b3efe9618
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSY7e91d826-7c57-4644-b1a6-48924b3efe9618
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
197518clindamycin HCl 150 MG Oral CapsulePSN363d5e7d-2734-4a26-8b7c-a75a707dbaae3
197518clindamycin 150 MG Oral CapsuleSCD363d5e7d-2734-4a26-8b7c-a75a707dbaae3
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSY363d5e7d-2734-4a26-8b7c-a75a707dbaae3
197518clindamycin HCl 150 MG Oral CapsulePSN685230d0-5596-5867-e053-2991aa0a23662
197518clindamycin HCl 150 MG Oral CapsulePSN3fc64a22-9db7-2117-e054-00144ff88e882
197518clindamycin 150 MG Oral CapsuleSCD685230d0-5596-5867-e053-2991aa0a23662
197518clindamycin 150 MG Oral CapsuleSCD3fc64a22-9db7-2117-e054-00144ff88e882
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSY685230d0-5596-5867-e053-2991aa0a23662
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSY3fc64a22-9db7-2117-e054-00144ff88e882
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-5708-0100591570801100 CAPSULE in 1 BOTTLE, PLASTIC (0591-5708-01) 100 capsule1991-07-312022-05-31NoNoCurrent