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BICILLIN C-R 900/300

Bicillin C-R 900/300 (penicillin G benzathine and penicillin G procaine injectable suspension) 2 mL Syringe

Approved
Approval ID

ba7b9199-4710-4189-a85d-77ed75befe4d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 13, 2023

Manufacturers
FDA

Pfizer Laboratories Div Pfizer Inc

DUNS: 134489525

Products 1

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 Code60793-602
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 (2)

PENICILLIN G BENZATHINEActive
Quantity: 900000 [iU] in 2 mL
Code: RIT82F58GK
Classification: ACTIM
PENICILLIN G PROCAINEActive
Quantity: 300000 [iU] in 2 mL
Code: 17R794ESYN
Classification: ACTIM

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BICILLIN C-R 900/300 - FDA Drug Approval Details