MedPath

BICILLIN L-A

Bicillin L-A (penicillin G benzathine injectable suspension) Disposable Syringe

Approved
Approval ID

a519a9bf-8fec-4fd3-b0b2-f4ae8c7f20ce

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 24, 2023

Manufacturers
FDA

A-S Medication Solutions

DUNS: 830016429

Products 2

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 Code50090-1016
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)

POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive
Code: K679OBS311
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PENICILLIN G BENZATHINEActive
Quantity: 1200000 [iU] in 2 mL
Code: RIT82F58GK
Classification: ACTIM

penicillin G benzathine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50090-1666
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)

CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive
Code: K679OBS311
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
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
PENICILLIN G BENZATHINEActive
Quantity: 600000 [iU] in 1 mL
Code: RIT82F58GK
Classification: ACTIM

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