NDC Code(s) : 60793-700-01, 60793-700-10, 60793-701-02, 60793-701-10, 60793-702-04, 60793-702-10
Packager : Pfizer Laboratories Div Pfizer Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BICILLIN L-Apenicillin G benzathine INJECTION, SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60793-700
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 1 mL
Inactive Ingredients
Ingredient Name Strength
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED(UNII: K679OBS311)
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:60793-700-1010 in 1 PACKAGE 27/06/1952
1NDC:60793-700-011 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 NDA050141 06/27/1952
BICILLIN L-Apenicillin G benzathine INJECTION, SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60793-701
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 G1200000 [iU] in 2 mL
Inactive Ingredients
Ingredient Name Strength
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED(UNII: K679OBS311)
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:60793-701-1010 in 1 PACKAGE 27/06/1952
1NDC:60793-701-022 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 NDA050141 06/27/1952
BICILLIN L-Apenicillin G benzathine INJECTION, SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60793-702
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 G2400000 [iU] in 4 mL
Inactive Ingredients
Ingredient Name Strength
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED(UNII: K679OBS311)
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:60793-702-1010 in 1 PACKAGE 27/06/1952
1NDC:60793-702-044 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 NDA050141 06/27/1952

LABELER - Pfizer Laboratories Div Pfizer Inc(134489525)

Establishment
Name Address ID/FEI Business Operations
King Pharmaceuticals LLC 962691478 ANALYSIS(60793-700, 60793-701, 60793-702), MANUFACTURE(60793-700, 60793-701, 60793-702), PACK(60793-700, 60793-701, 60793-702), LABEL(60793-700, 60793-701, 60793-702)

PRINCIPAL DISPLAY PANEL

NDC 60793-700-01

BICILLIN® L-A
(penicillin G benzathine injectable suspension)
600,000 units per 1 mL

FOR DEEP INTRAMUSCULAR
INJECTION ONLY
WARNING: FATAL IF
GIVEN BY OTHER ROUTES

Distributed by
Pfizer Inc
New York, NY 10017

PRINCIPAL DISPLAY PANEL - 1 mL Syringe Label

PRINCIPAL DISPLAY PANEL

NDC 60793-700-10
Contains 10 of NDC 60793-700-01

Ten Syringes (1 mL size)

Bicillin® L-A
(penicillin G benzathine injectable suspension)

600,000 units per 1 mL

FOR PEDIATRIC USE

FOR DEEP INTRAMUSCULAR INJECTION ONLY

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

Pfizer Injectables

Rx only

PRINCIPAL DISPLAY PANEL - 1 mL Syringe Package

PRINCIPAL DISPLAY PANEL

NDC 60793-701-02

BICILLIN® L-A
(penicillin G benzathine injectable suspension)
1,200,000 units per 2 mL

  •   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

PRINCIPAL DISPLAY PANEL

NDC 60793-701-10
Contains 10 of NDC 60793-701-02

Ten Syringes (2 mL size)

Bicillin® L-A
(penicillin G benzathine 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.

Pfizer Injectables

Rx only

PRINCIPAL DISPLAY PANEL - 2 mL Syringe Package

PRINCIPAL DISPLAY PANEL

NDC 60793-702-04

BICILLIN® L-A
(penicillin G benzathine
injectable suspension)
2,400,000 units per 4 mL

FOR DEEP INTRAMUSCULAR
INJECTION ONLY

WARNING: FATAL IF
GIVEN BY OTHER ROUTES

Distributed by
Pfizer Inc
New York, NY 10017

PRINCIPAL DISPLAY PANEL - 4 mL Syringe Label

PRINCIPAL DISPLAY PANEL

NDC 60793-702-10
Contains 10 of NDC 60793-702-04

Ten Syringes (4 mL size)

Bicillin® L-A
(penicillin G benzathine injectable suspension)

2,400,000 units per 4 mL

disposable syringe

FOR DEEP INTRAMUSCULAR INJECTION ONLY

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

Pfizer Injectables

Rx only

PRINCIPAL DISPLAY PANEL - 4 mL Syringe Package