Clindamycin hydrochloride
CLINDAMYCIN HYDROCHLORIDE CAPSULES, USPRx only
Approved
Approval ID
ab528098-e7c1-4f92-acb2-b664320a95a1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 13, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Clindamycin hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-1857
Application NumberANDA065061
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clindamycin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 13, 2012
FDA Product Classification
INGREDIENTS (13)
CLINDAMYCIN HYDROCHLORIDEActive
Quantity: 150 mg in 1 1
Code: T20OQ1YN1W
Classification: ACTIM
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERRIC OXIDE BLACKInactive
Code: XM0M87F357
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
Clindamycin hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5211
Application NumberANDA065061
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clindamycin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 13, 2012
FDA Product Classification
INGREDIENTS (12)
CLINDAMYCIN HYDROCHLORIDEActive
Quantity: 300 mg in 1 1
Code: T20OQ1YN1W
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERRIC OXIDE BLACKInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT