FDA.reportPublic FDA data

Clindamycin Hydrochloride

Product NDC
65862-186
11-digit product format
658620186
Labeler code
65862
Product ID
65862-186_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
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
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 HYDROCHLORIDE300 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
65862-186-01Clindamycin Hydrochloride100 in 1 BOTTLECAPSULE10022
65862-186-05Clindamycin Hydrochloride500 in 1 BOTTLECAPSULE50022
65862-186-16Clindamycin Hydrochloride16 in 1 BOTTLECAPSULE1622

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-186-01EA - Each65862-186190e0f2b-0860-4832-a239-e03c64a877a112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLINDAMYCIN HYDROCHLORIDEACTIVE INGREDIENTT20OQ1YN1WCLINDAMYCIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]7
CLINDAMYCINACTIVE MOIETY3U02EL437CCLINDAMYCIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCLINDAMYCIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]7
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCLINDAMYCIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CLINDAMYCIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]7
GELATININACTIVE INGREDIENT2G86QN327LCLINDAMYCIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLINDAMYCIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLINDAMYCIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]7
SHELLACINACTIVE INGREDIENT46N107B71OCLINDAMYCIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]7
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCLINDAMYCIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLINDAMYCIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]7
TALCINACTIVE INGREDIENT7SEV7J4R1UCLINDAMYCIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLINDAMYCIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]7
CLINDAMYCIN HYDROCHLORIDEACTIVE INGREDIENTT20OQ1YN1WCLINDAMYCIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
CLINDAMYCINACTIVE MOIETY3U02EL437CCLINDAMYCIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCLINDAMYCIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CLINDAMYCIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
GELATININACTIVE INGREDIENT2G86QN327LCLINDAMYCIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLINDAMYCIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLINDAMYCIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
SHELLACINACTIVE INGREDIENT46N107B71OCLINDAMYCIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCLINDAMYCIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLINDAMYCIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCLINDAMYCIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLINDAMYCIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-186CLINDAMYCIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]20Current NDC, Legacy NDC, 3 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
284215clindamycin HCl 300 MG Oral CapsulePSN9fe68a5a-487b-4119-9ee7-603948d732e410
284215clindamycin 300 MG Oral CapsuleSCD9fe68a5a-487b-4119-9ee7-603948d732e410
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSY9fe68a5a-487b-4119-9ee7-603948d732e410
284215clindamycin HCl 300 MG Oral CapsulePSN2393251d-33b9-4274-9d04-27ec9968eaa18
284215clindamycin 300 MG Oral CapsuleSCD2393251d-33b9-4274-9d04-27ec9968eaa18
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSY2393251d-33b9-4274-9d04-27ec9968eaa18
284215clindamycin HCl 300 MG Oral CapsulePSNc46cac0a-0c36-02fa-e053-2995a90a772b7
284215clindamycin 300 MG Oral CapsuleSCDc46cac0a-0c36-02fa-e053-2995a90a772b7
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSYc46cac0a-0c36-02fa-e053-2995a90a772b7
284215clindamycin HCl 300 MG Oral CapsulePSNd6e1a5f2-9dcb-49fb-a5b0-d7d543520ac36
284215clindamycin 300 MG Oral CapsuleSCDd6e1a5f2-9dcb-49fb-a5b0-d7d543520ac36
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSYd6e1a5f2-9dcb-49fb-a5b0-d7d543520ac36
284215clindamycin HCl 300 MG Oral CapsulePSNf2f08e98-f6c5-7c2d-e053-2995a90abe1e4
284215clindamycin 300 MG Oral CapsuleSCDf2f08e98-f6c5-7c2d-e053-2995a90abe1e4
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSYf2f08e98-f6c5-7c2d-e053-2995a90abe1e4
284215clindamycin HCl 300 MG Oral CapsulePSNd53a66bf-fdbd-4a12-8d8c-4e3ab94e9ef53
284215clindamycin HCl 300 MG Oral CapsulePSN0a0fbeae-2bc2-2402-e063-6394a90a97a03
284215clindamycin 300 MG Oral CapsuleSCD0a0fbeae-2bc2-2402-e063-6394a90a97a03
284215clindamycin 300 MG Oral CapsuleSCDd53a66bf-fdbd-4a12-8d8c-4e3ab94e9ef53
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSYd53a66bf-fdbd-4a12-8d8c-4e3ab94e9ef53
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSY0a0fbeae-2bc2-2402-e063-6394a90a97a03
284215clindamycin HCl 300 MG Oral CapsulePSN11aa9f41-9ebf-460c-925d-debea47e24502
284215clindamycin 300 MG Oral CapsuleSCD11aa9f41-9ebf-460c-925d-debea47e24502
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSY11aa9f41-9ebf-460c-925d-debea47e24502
284215clindamycin HCl 300 MG Oral CapsulePSN427a0138-c2dd-cf0b-e063-6394a90af4071
284215clindamycin 300 MG Oral CapsuleSCD427a0138-c2dd-cf0b-e063-6394a90af4071
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSY427a0138-c2dd-cf0b-e063-6394a90af4071

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-186-0165862018601100 CAPSULE in 1 BOTTLE (65862-186-01) 100 capsule2009-08-260000-00-00NoNoCurrent
65862-186-0565862018605500 CAPSULE in 1 BOTTLE (65862-186-05) 500 capsule2009-08-260000-00-00NoNoCurrent
65862-186-15658620186151500 CAPSULE in 1 BAG (65862-186-15)1500 capsule26-AUG-09Current
65862-186-166586201861616 CAPSULE in 1 BOTTLE (65862-186-16) 16 capsule2009-08-260000-00-00NoNoCurrent
65862-186-626586201866230000 CAPSULE in 1 BAG (65862-186-62)30000 capsule27-FEB-25Current