BICILLIN CR
Bicillin C-R (penicillin G benzathine and penicillin G procaine injectable suspension) Disposable Syringe for deep IM injection only
Approved
Approval ID
b5640fc6-76d8-428d-80e6-760d769af8bb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 13, 2023
Manufacturers
FDA
Pfizer Laboratories Div Pfizer Inc
DUNS: 134489525
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
penicillin G benzathine and penicillin G procaine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60793-601
Application NumberNDA050138
Product Classification
M
Marketing Category
C73594
G
Generic Name
penicillin G benzathine and penicillin G procaine
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateSeptember 12, 2023
FDA Product Classification
INGREDIENTS (9)
PENICILLIN G BENZATHINEActive
Quantity: 600000 [iU] in 2 mL
Code: RIT82F58GK
Classification: ACTIM
PENICILLIN G PROCAINEActive
Quantity: 600000 [iU] in 2 mL
Code: 17R794ESYN
Classification: ACTIM
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
CARBOXYMETHYLCELLULOSEInactive
Code: 05JZI7B19X
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
penicillin G benzathine and penicillin G procaine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60793-600
Application NumberNDA050138
Product Classification
M
Marketing Category
C73594
G
Generic Name
penicillin G benzathine and penicillin G procaine
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateSeptember 12, 2023
FDA Product Classification
INGREDIENTS (9)
PENICILLIN G BENZATHINEActive
Quantity: 600000 [iU] in 2 mL
Code: RIT82F58GK
Classification: ACTIM
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
CARBOXYMETHYLCELLULOSEInactive
Code: 05JZI7B19X
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PENICILLIN G PROCAINEActive
Quantity: 600000 [iU] in 2 mL
Code: 17R794ESYN
Classification: ACTIM