Clindamycin Hydrochloride

Product NDC
68071-3577
11-digit product format
680713577
Labeler code
68071
Product ID
68071-3577_213b41ae-ec9b-8154-e063-6394a90a080f
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
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
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
68071-3577-16807135770114 CAPSULE in 1 BOTTLE (68071-3577-1) 14 capsule2024-02-21NoNoHistorical
68071-3577-26807135770220 CAPSULE in 1 BOTTLE (68071-3577-2) 20 capsule2024-02-21NoNoHistorical
68071-3577-36807135770330 CAPSULE in 1 BOTTLE (68071-3577-3) 30 capsule2024-02-21NoNoHistorical
68071-3577-46807135770440 CAPSULE in 1 BOTTLE (68071-3577-4) 40 capsule2024-02-21NoNoHistorical
68071-3577-76807135770721 CAPSULE in 1 BOTTLE (68071-3577-7) 21 capsule2024-09-03NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Clindamycin Hydrochloride Capsules, USPNuCare Pharmaceuticals,Inc.2024-09-03HUMAN PRESCRIPTION DRUG LABEL5