Clindamycin Hydrochloride

Product NDC
65862-185
11-digit product format
658620185
Labeler code
65862
Product ID
65862-185_97a9034b-2c9f-48a0-95a0-62e60c49329c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA065442
Marketing category
ANDA
Marketing start
2009-08-26
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clindamycin Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLINDAMYCIN HYDROCHLORIDE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiT20OQ1YN1W
Rxcui197518, 284215

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
65862-185-01Clindamycin Hydrochloride100 in 1 BOTTLECAPSULE10022
65862-185-05Clindamycin Hydrochloride500 in 1 BOTTLECAPSULE50022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-185-01EA - Each65862-18549862960-e331-4baa-8bae-c4882f2ec3c912012-07-24
65862-185-05EA - Each65862-185aca80404-6b6a-49a8-b0d6-f28de0a1b8e512012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-185CLINDAMYCIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]20Current NDC, Legacy NDC, 2 package rows20240913_2367340c-d297-4a3f-8253-6d27a0ed39cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197518clindamycin HCl 150 MG Oral CapsulePSN2367340c-d297-4a3f-8253-6d27a0ed39cb22
284215clindamycin HCl 300 MG Oral CapsulePSN2367340c-d297-4a3f-8253-6d27a0ed39cb22
197518clindamycin 150 MG Oral CapsuleSCD2367340c-d297-4a3f-8253-6d27a0ed39cb22
284215clindamycin 300 MG Oral CapsuleSCD2367340c-d297-4a3f-8253-6d27a0ed39cb22
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSY2367340c-d297-4a3f-8253-6d27a0ed39cb22
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSY2367340c-d297-4a3f-8253-6d27a0ed39cb22
197518clindamycin HCl 150 MG Oral CapsulePSN8af1493c-1f22-4629-a432-f8b0578189e19
197518clindamycin 150 MG Oral CapsuleSCD8af1493c-1f22-4629-a432-f8b0578189e19
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSY8af1493c-1f22-4629-a432-f8b0578189e19
197518clindamycin HCl 150 MG Oral CapsulePSN50d70f26-662a-1ea2-e054-00144ff88e883
197518clindamycin 150 MG Oral CapsuleSCD50d70f26-662a-1ea2-e054-00144ff88e883
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSY50d70f26-662a-1ea2-e054-00144ff88e883

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-185-0165862018501100 CAPSULE in 1 BOTTLE (65862-185-01) 100 capsule2009-08-260000-00-00NoNoCurrent
65862-185-0565862018505500 CAPSULE in 1 BOTTLE (65862-185-05) 500 capsule2009-08-260000-00-00NoNoCurrent
65862-185-22658620185222000 CAPSULE in 1 BAG (65862-185-22)2000 capsule26-AUG-09Current
65862-185-406586201854040000 CAPSULE in 1 BAG (65862-185-40)40000 capsule27-FEB-25Current