BICILLIN CR
Bicillin C-R(penicillin G benzathine and penicillin G procaine injectable suspension) Disposable Syringe for deep IM injection only
Approved
Approval ID
4bd2cd7a-327d-48ed-9e8b-e6a03e3188d9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 30, 2013
Manufacturers
FDA
Dispensing Solutions, Inc.
DUNS: 066070785
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 Code68258-8910
Application NumberNDA050138
Product Classification
M
Marketing Category
C73594
G
Generic Name
penicillin G benzathine and penicillin G procaine
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateOctober 29, 2013
FDA Product Classification
INGREDIENTS (9)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
PENICILLIN G PROCAINEActive
Quantity: 600000 [iU] in 2 mL
Code: 17R794ESYN
Classification: ACTIM
CARBOXYMETHYLCELLULOSEInactive
Code: 05JZI7B19X
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
PENICILLIN G BENZATHINEActive
Quantity: 600000 [iU] in 2 mL
Code: RIT82F58GK
Classification: ACTIM
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 10/30/2013
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 68258-8910-02