FDA.reportPublic FDA data

Clindamycin Hydrochloride

Product NDC
68788-8558
11-digit product format
687888558
Labeler code
68788
Product ID
68788-8558_b6d64357-e0fc-48fc-9cf3-2a7cd550d333
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA216957
Marketing category
ANDA
Marketing start
2023-12-21
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

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
68788-8558-0Clindamycin Hydrochloride12 in 1 BOTTLECAPSULE123
68788-8558-1Clindamycin Hydrochloride14 in 1 BOTTLECAPSULE143
68788-8558-2Clindamycin Hydrochloride20 in 1 BOTTLECAPSULE203
68788-8558-3Clindamycin Hydrochloride30 in 1 BOTTLECAPSULE303
68788-8558-5Clindamycin Hydrochloride56 in 1 BOTTLECAPSULE563
68788-8558-6Clindamycin Hydrochloride60 in 1 BOTTLECAPSULE603
68788-8558-7Clindamycin Hydrochloride21 in 1 BOTTLECAPSULE213
68788-8558-8Clindamycin Hydrochloride28 in 1 BOTTLECAPSULE283

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8558CLINDAMYCIN HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 8 package rows20250305_51dfa3fa-6f6a-4904-a8d3-b5938cf9c852.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197518clindamycin HCl 150 MG Oral CapsulePSN51dfa3fa-6f6a-4904-a8d3-b5938cf9c8523
197518clindamycin 150 MG Oral CapsuleSCD51dfa3fa-6f6a-4904-a8d3-b5938cf9c8523
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSY51dfa3fa-6f6a-4904-a8d3-b5938cf9c8523

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8558-06878885580012 CAPSULE in 1 BOTTLE (68788-8558-0) 12 capsule2025-03-03NoNoCurrent
68788-8558-16878885580114 CAPSULE in 1 BOTTLE (68788-8558-1) 14 capsule2025-03-03NoNoCurrent
68788-8558-26878885580220 CAPSULE in 1 BOTTLE (68788-8558-2) 20 capsule2025-03-03NoNoCurrent
68788-8558-36878885580330 CAPSULE in 1 BOTTLE (68788-8558-3) 30 capsule2025-03-03NoNoCurrent
68788-8558-56878885580556 CAPSULE in 1 BOTTLE (68788-8558-5) 56 capsule2023-12-21NoNoCurrent
68788-8558-66878885580660 CAPSULE in 1 BOTTLE (68788-8558-6) 60 capsule2025-03-03NoNoCurrent
68788-8558-76878885580721 CAPSULE in 1 BOTTLE (68788-8558-7) 21 capsule2025-03-03NoNoCurrent
68788-8558-86878885580828 CAPSULE in 1 BOTTLE (68788-8558-8) 28 capsule2025-03-03NoNoCurrent