BICILLIN L-A
Bicillin L-A (penicillin G benzathine injectable suspension) Disposable Syringe
Approved
Approval ID
012d46f1-d0a0-4676-a879-cd320297ab16
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 13, 2023
Manufacturers
FDA
Pfizer Laboratories Div Pfizer Inc
DUNS: 134489525
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
penicillin G benzathine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60793-700
Application NumberNDA050141
Product Classification
M
Marketing Category
C73594
G
Generic Name
penicillin G benzathine
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateSeptember 12, 2023
FDA Product Classification
INGREDIENTS (8)
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PENICILLIN G BENZATHINEActive
Quantity: 600000 [iU] in 1 mL
Code: RIT82F58GK
Classification: ACTIM
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
penicillin G benzathine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60793-702
Application NumberNDA050141
Product Classification
M
Marketing Category
C73594
G
Generic Name
penicillin G benzathine
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateSeptember 12, 2023
FDA Product Classification
INGREDIENTS (8)
PENICILLIN G BENZATHINEActive
Quantity: 2400000 [iU] in 4 mL
Code: RIT82F58GK
Classification: ACTIM
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
penicillin G benzathine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60793-701
Application NumberNDA050141
Product Classification
M
Marketing Category
C73594
G
Generic Name
penicillin G benzathine
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateSeptember 12, 2023
FDA Product Classification
INGREDIENTS (8)
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311
Classification: IACT
PENICILLIN G BENZATHINEActive
Quantity: 1200000 [iU] in 2 mL
Code: RIT82F58GK
Classification: ACTIM
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT