FDA.reportPublic FDA data

CLINDAMYCIN HYDROCHLORIDE

Product NDC
68071-5189
11-digit product format
680715189
Labeler code
68071
Product ID
68071-5189_1b56d0c0-b8b2-3250-e063-6394a90ae67b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA207402
Marketing category
ANDA
Marketing start
2019-01-07
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
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 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-5189-32022-02-07C16284748780-1d6a99b39-533d-a426-e053-dadaa90af4c2Clindamycin Hydrochloride Capsules, USP
68071-5189-32022-01-28C16284748780-1d6a99b39-533d-a426-e053-dadaa90af4c2Clindamycin Hydrochloride Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-5189-1CLINDAMYCIN HYDROCHLORIDE21 in 1 BOTTLECAPSULE216
68071-5189-3CLINDAMYCIN HYDROCHLORIDE30 in 1 BOTTLECAPSULE306
68071-5189-4CLINDAMYCIN HYDROCHLORIDE40 in 1 BOTTLECAPSULE406
68071-5189-8CLINDAMYCIN HYDROCHLORIDE28 in 1 BOTTLECAPSULE286

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5189CLINDAMYCIN HYDROCHLORIDE CAPSULE [NUCARE PHARMACEUTICALS,INC.]6Current NDC, Legacy NDC, 4 package rows20240622_9fe44bdd-eb59-4b55-e053-2995a90a3183.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197518clindamycin HCl 150 MG Oral CapsulePSN9fe44bdd-eb59-4b55-e053-2995a90a31836
197518clindamycin 150 MG Oral CapsuleSCD9fe44bdd-eb59-4b55-e053-2995a90a31836
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSY9fe44bdd-eb59-4b55-e053-2995a90a31836

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-5189-16807151890121 CAPSULE in 1 BOTTLE (68071-5189-1) 21 capsule2020-03-020000-00-00NoNoCurrent
68071-5189-36807151890330 CAPSULE in 1 BOTTLE (68071-5189-3) 30 capsule2020-03-020000-00-00NoNoCurrent
68071-5189-46807151890440 CAPSULE in 1 BOTTLE (68071-5189-4) 40 capsule2020-03-020000-00-00NoNoCurrent
68071-5189-86807151890828 CAPSULE in 1 BOTTLE (68071-5189-8) 28 capsule2020-03-020000-00-00NoNoCurrent