Clindamycin Hydrochloride

Product NDC
68071-3582
11-digit product format
680713582
Labeler code
68071
Product ID
68071-3582_33a14d92-da84-996c-e063-6394a90ae3b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA216957
Marketing category
ANDA
Marketing start
2023-03-10
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
T20OQ1YN1WCLINDAMYCIN HYDROCHLORIDE21462-39-5CLINDAMYCIN HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3582-16807135820121 CAPSULE in 1 BOTTLE (68071-3582-1) 21 capsule2025-04-25NoNoHistorical
68071-3582-36807135820330 CAPSULE in 1 BOTTLE (68071-3582-3) 30 capsule2024-03-04NoNoHistorical
68071-3582-46807135820414 CAPSULE in 1 BOTTLE (68071-3582-4) 14 capsule2025-01-28NoNoHistorical
68071-3582-66807135820660 CAPSULE in 1 BOTTLE (68071-3582-6) 60 capsule2024-11-08NoNoHistorical
68071-3582-76807135820740 CAPSULE in 1 BOTTLE (68071-3582-7) 40 capsule2025-02-13NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Clindamycin Hydrochloride Capsules, USPNuCare Pharmaceuticals,Inc.2025-04-25HUMAN PRESCRIPTION DRUG LABEL5