FDA.reportPublic FDA data

CLINDAMYCIN HYDROCHLORIDE

Product NDC
76420-615
11-digit product format
764200615
Labeler code
76420
Product ID
76420-615_054ad3e6-3c9c-e6d2-e063-6294a90ab46f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA207402
Marketing category
ANDA
Marketing start
2019-01-07
Substance
CLINDAMYCIN HYDROCHLORIDE
Active strength
75 mg/1
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CLINDAMYCIN HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLINDAMYCIN HYDROCHLORIDE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiT20OQ1YN1W
Rxcui197518, 284215, 309329

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-615-01CLINDAMYCIN HYDROCHLORIDE100 in 1 BOTTLECAPSULE1001
76420-615-12CLINDAMYCIN HYDROCHLORIDE12 in 1 BOTTLECAPSULE121
76420-615-20CLINDAMYCIN HYDROCHLORIDE20 in 1 BOTTLECAPSULE201
76420-615-21CLINDAMYCIN HYDROCHLORIDE21 in 1 BOTTLECAPSULE211
76420-615-30CLINDAMYCIN HYDROCHLORIDE30 in 1 BOTTLECAPSULE301
76420-615-60CLINDAMYCIN HYDROCHLORIDE60 in 1 BOTTLECAPSULE601
76420-615-90CLINDAMYCIN HYDROCHLORIDE90 in 1 BOTTLECAPSULE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-615CLINDAMYCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE) CAPSULE [ASCLEMED USA, INC.]1Current NDC, 7 package rows20230915_7d3e6ec5-93e9-4ce0-8276-b19aa97eb772.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197518clindamycin HCl 150 MG Oral CapsulePSN7d3e6ec5-93e9-4ce0-8276-b19aa97eb7721
284215clindamycin HCl 300 MG Oral CapsulePSN7d3e6ec5-93e9-4ce0-8276-b19aa97eb7721
309329clindamycin HCl 75 MG Oral CapsulePSN7d3e6ec5-93e9-4ce0-8276-b19aa97eb7721
197518clindamycin 150 MG Oral CapsuleSCD7d3e6ec5-93e9-4ce0-8276-b19aa97eb7721
284215clindamycin 300 MG Oral CapsuleSCD7d3e6ec5-93e9-4ce0-8276-b19aa97eb7721
309329clindamycin 75 MG Oral CapsuleSCD7d3e6ec5-93e9-4ce0-8276-b19aa97eb7721
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSY7d3e6ec5-93e9-4ce0-8276-b19aa97eb7721
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSY7d3e6ec5-93e9-4ce0-8276-b19aa97eb7721
309329clindamycin (as clindamycin hydrochloride) 75 MG Oral CapsuleSY7d3e6ec5-93e9-4ce0-8276-b19aa97eb7721

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-615-0176420061501100 CAPSULE in 1 BOTTLE (76420-615-01) 100 capsule2023-09-14NoNoCurrent
76420-615-127642006151212 CAPSULE in 1 BOTTLE (76420-615-12) 12 capsule2023-09-14NoNoCurrent
76420-615-207642006152020 CAPSULE in 1 BOTTLE (76420-615-20) 20 capsule2023-09-14NoNoCurrent
76420-615-217642006152121 CAPSULE in 1 BOTTLE (76420-615-21) 21 capsule2023-09-14NoNoCurrent
76420-615-307642006153030 CAPSULE in 1 BOTTLE (76420-615-30) 30 capsule2023-09-14NoNoCurrent
76420-615-607642006156060 CAPSULE in 1 BOTTLE (76420-615-60) 60 capsule2023-09-14NoNoCurrent
76420-615-907642006159090 CAPSULE in 1 BOTTLE (76420-615-90) 90 capsule2023-09-14NoNoCurrent