NDC Code(s) : 60793-601-02, 60793-601-10, 60793-600-02, 60793-600-10
Packager : Pfizer Laboratories Div Pfizer Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BICILLIN CRpenicillin G benzathine and penicillin G procaine INJECTION, SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60793-601
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PENICILLIN G BENZATHINE(UNII: RIT82F58GK)
(PENICILLIN G - UNII:Q42T66VG0C) 		PENICILLIN G600000 [iU] in 2 mL
PENICILLIN G PROCAINE(UNII: 17R794ESYN)
(PENICILLIN G - UNII:Q42T66VG0C) 		PENICILLIN G600000 [iU] in 2 mL
Inactive Ingredients
Ingredient Name Strength
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
CARBOXYMETHYLCELLULOSE(UNII: 05JZI7B19X)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
SODIUM CITRATE, UNSPECIFIED FORM(UNII: 1Q73Q2JULR)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60793-601-1010 in 1 PACKAGE 18/05/1953
1NDC:60793-601-022 mL in 1 SYRINGE Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050138 05/18/1953
BICILLIN CRpenicillin G benzathine and penicillin G procaine INJECTION, SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60793-600
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PENICILLIN G BENZATHINE(UNII: RIT82F58GK)
(PENICILLIN G - UNII:Q42T66VG0C) 		PENICILLIN G600000 [iU] in 2 mL
PENICILLIN G PROCAINE(UNII: 17R794ESYN)
(PENICILLIN G - UNII:Q42T66VG0C) 		PENICILLIN G600000 [iU] in 2 mL
Inactive Ingredients
Ingredient Name Strength
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
CARBOXYMETHYLCELLULOSE(UNII: 05JZI7B19X)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
SODIUM CITRATE, UNSPECIFIED FORM(UNII: 1Q73Q2JULR)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60793-600-1010 in 1 PACKAGE 18/05/1953
1NDC:60793-600-022 mL in 1 SYRINGE Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050138 05/18/1953

LABELER - Pfizer Laboratories Div Pfizer Inc(134489525)

Establishment
Name Address ID/FEI Business Operations
King Pharmaceuticals LLC 962691478 ANALYSIS(60793-600, 60793-601), MANUFACTURE(60793-600, 60793-601), PACK(60793-600, 60793-601), LABEL(60793-600, 60793-601)

PRINCIPAL DISPLAY PANEL

NDC 60793-601-02

BICILLIN® C-R
(600,000 units penicillin G benzathine and
600,000 units penicillin G procaine injectable
suspension)
1,200,000 units per 2 mL
Not for the Treatment of Syphilis
FOR DEEP INTRAMUSCULAR INJECTION ONLY
WARNING: FATAL IF GIVEN BY OTHER ROUTES

Distributed by
Pfizer Inc
New York, NY 10017

PRINCIPAL DISPLAY PANEL - 2 mL Syringe Label - 601

PRINCIPAL DISPLAY PANEL

NDC 60793-601-10
Contains 10 of NDC 60793-601-02

Ten Syringes (2 mL size)

  •  Bicillin® C-R
    (penicillin G benzathine and penicillin G procaine
    injectable suspension)

1,200,000 units per 2 mL

FOR PEDIATRIC USE

FOR DEEP INTRAMUSCULAR INJECTION ONLY

WARNING: FATAL IF GIVEN BY OTHER ROUTES
BEFORE INJECTING, SEE PACKAGE INSERT FOR ADMINISTRATION INSTRUCTIONS.

NOT FOR THE TREATMENT OF SYPHILIS

Pfizer Injectables

Rx only

PRINCIPAL DISPLAY PANEL - 2 mL Syringe Package - 601

PRINCIPAL DISPLAY PANEL

NDC 60793-600-02

BICILLIN® C-R
(penicillin G benzathine and penicillin G
procaine injectable suspension in equal
portions)
1,200,000 units per 2 mL
Not for the Treatment of Syphilis
FOR DEEP INTRAMUSCULAR INJECTION ONLY
WARNING: FATAL IF GIVEN BY OTHER ROUTES

Distributed by
Pfizer Inc
New York, NY 10017

PRINCIPAL DISPLAY PANEL - 2 mL Syringe Label - 600

PRINCIPAL DISPLAY PANEL

NDC 60793-600-10
Contains 10 of NDC 60793-600-02

Ten Syringes (2 mL size)

Bicillin® C-R
(penicillin G benzathine and penicillin G procaine
injectable suspension)

1,200,000 units per 2 mL

FOR DEEP INTRAMUSCULAR INJECTION ONLY

WARNING: FATAL IF GIVEN BY OTHER ROUTES
BEFORE INJECTING, SEE PACKAGE INSERT FOR ADMINISTRATION INSTRUCTIONS.

NOT FOR THE TREATMENT OF SYPHILIS

Pfizer Injectables

Rx only

PRINCIPAL DISPLAY PANEL - 2 mL Syringe Package - 600