Penicillin G Injectable Solution

Brand(s)
Pfizerpen
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sandoz Inc (2015-03-10)
Oldest Current Product
2001-02-26
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\PENICILLIN G
FDAOB
INJECTION\INJECTION\PENICILLIN G POTASSIUM\rdfq
INTRAMUSCULAR, INTRAVENOUS\INJECTION\PENICILLIN G SODIUM\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\PENICILLIN G POTASSIUM
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\PENICILLIN G SODIUM
INTRAMUSCULAR\POWDER, FOR SOLUTION\PENICILLIN G POTASSIUM
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\PENICILLIN G POTASSIUM
INTRAVENOUS\POWDER, FOR SOLUTION\PENICILLIN G POTASSIUM
SPL Moiety
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\PENICILLIN G
INTRAMUSCULAR\POWDER, FOR SOLUTION\PENICILLIN G
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\PENICILLIN G
INTRAVENOUS\POWDER, FOR SOLUTION\PENICILLIN G

product(s) by strength(s)

penicillin g potassium 1000000 unt/ml injectable solution

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000490520PfizerpenANDARoerig2010-06-01PENICILLIN G POTASSIUMINTRAMUSCULARPOWDER, FOR SOLUTIONANDA060657d8aaefb6-3f7d-4bc5-b40a-1c58c3054320, ec07bcce-fc40-4a35-8c32-6577e0ac192c, efef4846-9497-41af-8dd6-518f86eca7f2
2000490530PfizerpenANDARoerig2010-06-01PENICILLIN G POTASSIUMINTRAVENOUSPOWDER, FOR SOLUTIONANDA060657d8aaefb6-3f7d-4bc5-b40a-1c58c3054320, ec07bcce-fc40-4a35-8c32-6577e0ac192c, efef4846-9497-41af-8dd6-518f86eca7f2
3007816135ANDASandoz Inc2001-08-30PENICILLIN G POTASSIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA06507991950983-4884-40d1-abd8-bcc953d61b7f
4007816136ANDASandoz Inc2001-08-30PENICILLIN G POTASSIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA06507991950983-4884-40d1-abd8-bcc953d61b7f
5445670310ANDAWg Critical Care, Llc2012-05-10PENICILLIN G POTASSIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA065149e0ced9d8-b9ea-466e-bf2c-10e9cc636f3f
6445670311ANDAWg Critical Care, Llc2012-05-10PENICILLIN G POTASSIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA065149e0ced9d8-b9ea-466e-bf2c-10e9cc636f3f
7445670312ANDAWg Critical Care, Llc2012-05-10PENICILLIN G POTASSIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA065149e0ced9d8-b9ea-466e-bf2c-10e9cc636f3f
8633230323ANDAApp Pharmaceuticals, Llc2009-09-01PENICILLIN G POTASSIUMINTRAMUSCULARPOWDER, FOR SOLUTIONANDA065448c9245222-d038-4d45-a76d-1ec4a2070444
9633230324ANDAApp Pharmaceuticals, Llc2009-09-01PENICILLIN G POTASSIUMINTRAVENOUSPOWDER, FOR SOLUTIONANDA065448c9245222-d038-4d45-a76d-1ec4a2070444

penicillin g sodium 100000 unt/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007816153ANDASandoz Inc2001-02-26PENICILLIN G SODIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA06506823b6d4a3-b273-4e10-9da9-1376933fdbdf

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA060074PENICILLIN G POTASSIUMTruePFIZER LABORATORIES DIV PFIZER INCANDA060074_003Penicillin G Injection
2ANDA060362PENICILLIN G POTASSIUMTrueAPOTHECON INC DIV BRISTOL MYERS SQUIBBANDA060362_001, ANDA060362_002, ANDA060362_003, ANDA060362_004Penicillin G Injection
3ANDA060384PENICILLIN G POTASSIUMTrueELI LILLY AND COANDA060384_001, ANDA060384_002, ANDA060384_003, ANDA060384_004, ANDA060384_005Penicillin G Injection
4ANDA060601PENICILLIN G POTASSIUMTrueELI LILLY AND COANDA060601_001Penicillin G Injection
5ANDA060657PFIZERPENPFIZER LABORATORIES DIV PFIZER INCANDA060657_001, ANDA060657_002, ANDA060657_003Penicillin G Injection
6ANDA060806PENICILLIN G POTASSIUMTrueCONSOLIDATED PHARMACEUTICAL GROUP INCANDA060806_001, ANDA060806_002, ANDA060806_003, ANDA060806_004Penicillin G Injection
7ANDA062003PENICILLIN G POTASSIUMTruePARKE DAVIS DIV WARNER LAMBERT COANDA062003_001, ANDA062003_002Penicillin G Injection
8ANDA062991PENICILLIN G POTASSIUMTrueWATSON LABORATORIES INC1988-09-13ANDA062991_001, ANDA062991_002, ANDA062991_003, ANDA062991_004Penicillin G Injection
9ANDA063014PENICILLIN G SODIUMTrueWATSON LABORATORIES INC1988-09-13ANDA063014_001
10ANDA065068PENICILLIN G SODIUMSANDOZ INC2001-02-26ANDA065068_001
11ANDA065079PENICILLIN G POTASSIUMSANDOZ INC2002-08-30ANDA065079_001, ANDA065079_002, ANDA065079_003Penicillin G Injection
12ANDA065149PENICILLIN G POTASSIUMGC HANFORD MANUFACTURING CO2009-07-23ANDA065149_001, ANDA065149_002, ANDA065149_003Penicillin G Injection
13ANDA065448PENICILLIN G POTASSIUMISTITUTO BIOCHIMICO ITALIANO SPA2009-08-18ANDA065448_001, ANDA065448_002Penicillin G Injection
14NDA050638PENICILLIN G POTASSIUM IN PLASTIC CONTAINERBAXTER HEALTHCARE CORP1990-06-25NDA050638_001, NDA050638_002, NDA050638_003Penicillin G Injection

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA060074_003discontinuedPENICILLIN G POTASSIUM (20,000,000 UNITS/VIAL)INJECTIONFalsePENICILLIN G POTASSIUM
2ANDA060362_001discontinuedPENICILLIN G POTASSIUM (1,000,000 UNITS/VIAL)INJECTIONFalsePENICILLIN G POTASSIUM
3ANDA060362_002discontinuedPENICILLIN G POTASSIUM (20,000,000 UNITS/VIAL)INJECTIONFalsePENICILLIN G POTASSIUM
4ANDA060362_003discontinuedPENICILLIN G POTASSIUM (5,000,000 UNITS/VIAL)INJECTIONFalsePENICILLIN G POTASSIUM
5ANDA060362_004discontinuedPENICILLIN G POTASSIUM (10,000,000 UNITS/VIAL)INJECTIONFalsePENICILLIN G POTASSIUM
6ANDA060384_001discontinuedPENICILLIN G POTASSIUM (5,000,000 UNITS/VIAL)INJECTIONFalsePENICILLIN G POTASSIUM
7ANDA060384_002discontinuedPENICILLIN G POTASSIUM (1,000,000 UNITS/VIAL)INJECTIONFalsePENICILLIN G POTASSIUM
8ANDA060384_003discontinuedPENICILLIN G POTASSIUM (500,000 UNITS/VIAL)INJECTIONFalsePENICILLIN G POTASSIUM
9ANDA060384_004discontinuedPENICILLIN G POTASSIUM (200,000 UNITS/VIAL)INJECTIONFalsePENICILLIN G POTASSIUM
10ANDA060384_005discontinuedPENICILLIN G POTASSIUM (20,000,000 UNITS/VIAL)INJECTIONFalsePENICILLIN G POTASSIUM
11ANDA060601_001discontinuedPENICILLIN G POTASSIUM (20,000,000 UNITS/VIAL)INJECTIONFalsePENICILLIN G POTASSIUM
12ANDA060657_001discontinuedPENICILLIN G POTASSIUM (1,000,000 UNITS/VIAL)INJECTIONFalsePFIZERPEN
13ANDA060657_002RXPENICILLIN G POTASSIUM (5,000,000 UNITS/VIAL)INJECTIONTrueAPPFIZERPEN
14ANDA060657_003RXPENICILLIN G POTASSIUM (20,000,000 UNITS/VIAL)INJECTIONTrueAPPFIZERPEN
15ANDA060806_001discontinuedPENICILLIN G POTASSIUM (500,000 UNITS/VIAL)INJECTIONFalsePENICILLIN G POTASSIUM
16ANDA060806_002discontinuedPENICILLIN G POTASSIUM (1,000,000 UNITS/VIAL)INJECTIONFalsePENICILLIN G POTASSIUM
17ANDA060806_003discontinuedPENICILLIN G POTASSIUM (5,000,000 UNITS/VIAL)INJECTIONFalsePENICILLIN G POTASSIUM
18ANDA060806_004discontinuedPENICILLIN G POTASSIUM (10,000,000 UNITS/VIAL)INJECTIONFalsePENICILLIN G POTASSIUM
19ANDA062003_001discontinuedPENICILLIN G POTASSIUM (1,000,000 UNITS/VIAL)INJECTIONFalsePENICILLIN G POTASSIUM
20ANDA062003_002discontinuedPENICILLIN G POTASSIUM (5,000,000 UNITS/VIAL)INJECTIONFalsePENICILLIN G POTASSIUM
21ANDA062991_001discontinuedPENICILLIN G POTASSIUM (1,000,000 UNITS/VIAL)INJECTIONFalse1988-09-13PENICILLIN G POTASSIUM
22ANDA062991_002discontinuedPENICILLIN G POTASSIUM (5,000,000 UNITS/VIAL)INJECTIONFalse1988-09-13PENICILLIN G POTASSIUM
23ANDA062991_003discontinuedPENICILLIN G POTASSIUM (10,000,000 UNITS/VIAL)INJECTIONFalse1988-09-13PENICILLIN G POTASSIUM
24ANDA062991_004discontinuedPENICILLIN G POTASSIUM (20,000,000 UNITS/VIAL)INJECTIONFalse1988-09-13PENICILLIN G POTASSIUM
25ANDA063014_001discontinuedPENICILLIN G SODIUM (5,000,000 UNITS/VIAL)INJECTIONFalse1988-09-13PENICILLIN G SODIUM
26ANDA065068_001RXPENICILLIN G SODIUM (5,000,000 UNITS/VIAL)INJECTIONTrue2001-02-26PENICILLIN G SODIUM
27ANDA065079_001discontinuedPENICILLIN G POTASSIUM (1,000,000 UNITS/VIAL)INJECTIONFalse2002-08-30PENICILLIN G POTASSIUM
28ANDA065079_002RXPENICILLIN G POTASSIUM (5,000,000 UNITS/VIAL)INJECTIONFalseAP2002-08-30PENICILLIN G POTASSIUM
29ANDA065079_003RXPENICILLIN G POTASSIUM (20,000,000 UNITS/VIAL)INJECTIONFalseAP2002-08-30PENICILLIN G POTASSIUM
30ANDA065149_001RXPENICILLIN G POTASSIUM (1,000,000 UNITS/VIAL)INJECTIONFalse2009-07-23PENICILLIN G POTASSIUM
31ANDA065149_002RXPENICILLIN G POTASSIUM (5,000,000 UNITS/VIAL)INJECTIONFalseAP2009-07-23PENICILLIN G POTASSIUM
32ANDA065149_003RXPENICILLIN G POTASSIUM (20,000,000 UNITS/VIAL)INJECTIONFalseAP2009-07-23PENICILLIN G POTASSIUM
33ANDA065448_001RXPENICILLIN G POTASSIUM (5,000,000 UNITS/VIAL)INJECTIONFalseAP2009-08-18PENICILLIN G POTASSIUM
34ANDA065448_002RXPENICILLIN G POTASSIUM (20,000,000 UNITS/VIAL)INJECTIONFalseAP2009-08-18PENICILLIN G POTASSIUM
35NDA050638_001RXPENICILLIN G POTASSIUM (20,000 UNITS/ML)INJECTIONTrue1990-06-25PENICILLIN G POTASSIUM IN PLASTIC CONTAINER
36NDA050638_002RXPENICILLIN G POTASSIUM (40,000 UNITS/ML)INJECTIONTrue1990-06-25PENICILLIN G POTASSIUM IN PLASTIC CONTAINER
37NDA050638_003RXPENICILLIN G POTASSIUM (60,000 UNITS/ML)INJECTIONTrue1990-06-25PENICILLIN G POTASSIUM IN PLASTIC CONTAINER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
123b6d4a3-b273-4e10-9da9-1376933fdbdf (view SPL)Penicillin G Sodium for Injection, USP 5,000,000 Units (5 million units)prescriptionHuman PrescriptionSandoz Inc2014-05-1212007816153
291950983-4884-40d1-abd8-bcc953d61b7f (view SPL)Penicillin G Potassium for Injection, USPprescriptionHuman PrescriptionSandoz Inc2015-03-1014007816135, 007816136
3c9245222-d038-4d45-a76d-1ec4a2070444 (view SPL)Penicillin G Potassium for Injection, USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2012-09-203633230323, 633230324
4d8aaefb6-3f7d-4bc5-b40a-1c58c3054320 (view SPL)Buffered PFIZERPEN (penicillin G potassium) for InjectionprescriptionHuman PrescriptionRoerigANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2014-11-219000490520, 000490530
5e0ced9d8-b9ea-466e-bf2c-10e9cc636f3f (view SPL)Penicillin G Potassium for Injection, USPprescriptionHuman PrescriptionWg Critical Care, Llc2013-01-313445670310, 445670311, 445670312
6ec07bcce-fc40-4a35-8c32-6577e0ac192c (view SPL)Buffered PFIZERPEN (penicillin G potassium) for InjectionprescriptionHuman PrescriptionRoerigANALYSIS, API MANUFACTURE, MANUFACTURE2011-04-253000490520, 000490530
7efef4846-9497-41af-8dd6-518f86eca7f2 (view SPL)Buffered PFIZERPEN (penicillin G potassium) for InjectionprescriptionHuman PrescriptionRoerigANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2015-10-067000490520, 000490530

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII