Penicillin V Oral Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Teva Pharmaceuticals Usa Inc (2014-12-03)
Oldest Current Product
1968-07-31
License(s)
ANDA
RxNORM
ORAL SOLUTION\PENICILLIN V
FDAOB
ORAL\FOR SOLUTION\PENICILLIN V POTASSIUM
SPL Active
ORAL\FOR SOLUTION\PENICILLIN V POTASSIUM
ORAL\POWDER, FOR SOLUTION\PENICILLIN V POTASSIUM
SPL Moiety
ORAL\FOR SOLUTION\PENICILLIN V
ORAL\POWDER, FOR SOLUTION\PENICILLIN V

product(s) by strength(s)

penicillin v potassium 25 mg/ml oral solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000934125ANDATeva Pharmaceuticals Usa Inc1990-09-30PENICILLIN V POTASSIUMORALPOWDER, FOR SOLUTIONANDA0604563111ca84-6f8e-45ea-91a1-9cb99c63607e
2672530202ANDADava Pharmaceuticals, Inc.2004-02-01PENICILLIN V POTASSIUMORALFOR SOLUTIONANDA062981d6417642-66c5-48b5-86bf-ffb87c4250ac

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950772ANDARebel Distributors Corp1968-07-31PENICILLIN V POTASSIUMORALPOWDER, FOR SOLUTION000934125ANDA060456d291f309-1a61-4e32-a684-5b32e7bcb518
2548684125ANDAPhysicians Total Care, Inc.1992-04-19PENICILLIN V POTASSIUMORALPOWDER, FOR SOLUTION000934125ANDA0604562bfee83c-4f38-440e-9061-58036490d009
3687889853ANDAPreferred Pharmaceuticals, Inc.2012-03-14PENICILLIN V POTASSIUMORALPOWDER, FOR SOLUTION000934125ANDA0604568c342c78-47fb-4f6b-9451-68b1f752555c

penicillin v potassium 50 mg/ml oral solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000934127ANDATeva Pharmaceuticals Usa Inc1990-09-30PENICILLIN V POTASSIUMORALPOWDER, FOR SOLUTIONANDA0604563111ca84-6f8e-45ea-91a1-9cb99c63607e
2672530203ANDADava Pharmaceuticals, Inc.2004-02-01PENICILLIN V POTASSIUMORALFOR SOLUTIONANDA062981d6417642-66c5-48b5-86bf-ffb87c4250ac

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950559ANDARebel Distributors Corp1968-07-31PENICILLIN V POTASSIUMORALPOWDER, FOR SOLUTION000934127ANDA060456d291f309-1a61-4e32-a684-5b32e7bcb518
2545692933ANDAA-S Medication Solutions Llc1990-09-30PENICILLIN V POTASSIUMORALPOWDER, FOR SOLUTION000934127ANDA060456f1070e7c-a9a0-4a08-baf6-dc1cab3648ef
3545692935ANDAA-S Medication Solutions Llc1990-09-30PENICILLIN V POTASSIUMORALPOWDER, FOR SOLUTION000934127ANDA0604563c6d4fc6-1753-4d81-8284-c9c81e7bf646
4548681780ANDAPhysicians Total Care, Inc.2003-11-10PENICILLIN V POTASSIUMORALPOWDER, FOR SOLUTION000934127ANDA0604562bfee83c-4f38-440e-9061-58036490d009
5631870533ANDAProficient Rx Lp1990-09-30PENICILLIN V POTASSIUMORALPOWDER, FOR SOLUTION000934127ANDA060456316aa904-09f1-4a8e-9adf-93cfc14f9a0a
6687889852ANDAPreferred Pharmaceuticals, Inc.2012-03-14PENICILLIN V POTASSIUMORALPOWDER, FOR SOLUTION000934127ANDA0604568c342c78-47fb-4f6b-9451-68b1f752555c

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA060004V-CILLIN KTrueELI LILLY AND COANDA060004_001, ANDA060004_002
2ANDA060007PEN-VEE KTrueWYETH AYERST LABORATORIESANDA060007_001, ANDA060007_002
3ANDA060136LEDERCILLIN VKTrueLEDERLE LABORATORIES DIV AMERICAN CYANAMID COANDA060136_001, ANDA060136_002
4ANDA060456PENICILLIN-VKTEVA PHARMACEUTICALS USA INCANDA060456_001, ANDA060456_002
5ANDA061149BETAPEN-VKTrueAPOTHECON INC DIV BRISTOL MYERS SQUIBBANDA061149_001, ANDA061149_002
6ANDA061206VEETIDS '125'TrueAPOTHECON SUB BRISTOL MYERS SQUIBB COANDA061206_001, ANDA061206_002
7ANDA061410VEETIDSTrueAPOTHECON INC DIV BRISTOL MYERS SQUIBBANDA061410_001, ANDA061410_002
8ANDA061529PENICILLIN V POTASSIUMTrueAMERICAN ANTIBIOTICS LLCANDA061529_001, ANDA061529_002
9ANDA061624PENICILLIN V POTASSIUMTrueMYLAN PHARMACEUTICALS INCANDA061624_001, ANDA061624_002
10ANDA061758PENICILLIN V POTASSIUMTruePUREPAC PHARMACEUTICAL COANDA061758_001, ANDA061758_002
11ANDA061815PFIZERPEN VKTruePFIZER LABORATORIES DIV PFIZER INCANDA061815_001, ANDA061815_002
12ANDA062002PENAPAR-VKTruePARKE DAVIS DIV WARNER LAMBERT COANDA062002_001, ANDA062002_002
13ANDA062153VEETIDS '125'TrueAPOTHECON SUB BRISTOL MYERS SQUIBB COANDA062153_001, ANDA062153_002
14ANDA062270BEEPEN-VKTrueGLAXOSMITHKLINEANDA062270_001, ANDA062270_002
15ANDA062981PENICILLIN V POTASSIUMDAVA PHARMACEUTICALS INC1989-02-10ANDA062981_001, ANDA062981_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA060004_001discontinuedPENICILLIN V POTASSIUM (EQ 125MG BASE/5ML)ORALFOR SOLUTIONFalseV-CILLIN K
2ANDA060004_002discontinuedPENICILLIN V POTASSIUM (EQ 250MG BASE/5ML)ORALFOR SOLUTIONFalseV-CILLIN K
3ANDA060007_001discontinuedPENICILLIN V POTASSIUM (EQ 125MG BASE/5ML)ORALFOR SOLUTIONFalsePEN-VEE K
4ANDA060007_002discontinuedPENICILLIN V POTASSIUM (EQ 250MG BASE/5ML)ORALFOR SOLUTIONFalsePEN-VEE K
5ANDA060136_001discontinuedPENICILLIN V POTASSIUM (EQ 125MG BASE/5ML)ORALFOR SOLUTIONFalseLEDERCILLIN VK
6ANDA060136_002discontinuedPENICILLIN V POTASSIUM (EQ 250MG BASE/5ML)ORALFOR SOLUTIONFalseLEDERCILLIN VK
7ANDA060456_001RXPENICILLIN V POTASSIUM (EQ 125MG BASE/5ML)ORALFOR SOLUTIONFalseAAPENICILLIN-VK
8ANDA060456_002RXPENICILLIN V POTASSIUM (EQ 250MG BASE/5ML)ORALFOR SOLUTIONTrueAAPENICILLIN-VK
9ANDA061149_001discontinuedPENICILLIN V POTASSIUM (EQ 125MG BASE/5ML)ORALFOR SOLUTIONFalseBETAPEN-VK
10ANDA061149_002discontinuedPENICILLIN V POTASSIUM (EQ 250MG BASE/5ML)ORALFOR SOLUTIONFalseBETAPEN-VK
11ANDA061206_001discontinuedPENICILLIN V POTASSIUM (EQ 125MG BASE/5ML)ORALFOR SOLUTIONFalseVEETIDS '125'
12ANDA061206_002discontinuedPENICILLIN V POTASSIUM (EQ 250MG BASE/5ML)ORALFOR SOLUTIONFalseVEETIDS '125'
13ANDA061410_001discontinuedPENICILLIN V POTASSIUM (EQ 125MG BASE/5ML)ORALFOR SOLUTIONFalseVEETIDS
14ANDA061410_002discontinuedPENICILLIN V POTASSIUM (EQ 250MG BASE/5ML)ORALFOR SOLUTIONFalseVEETIDS
15ANDA061529_001discontinuedPENICILLIN V POTASSIUM (EQ 125MG BASE/5ML)ORALFOR SOLUTIONFalsePENICILLIN V POTASSIUM
16ANDA061529_002discontinuedPENICILLIN V POTASSIUM (EQ 250MG BASE/5ML)ORALFOR SOLUTIONFalsePENICILLIN V POTASSIUM
17ANDA061624_001discontinuedPENICILLIN V POTASSIUM (EQ 250MG BASE/5ML)ORALFOR SOLUTIONFalsePENICILLIN V POTASSIUM
18ANDA061624_002discontinuedPENICILLIN V POTASSIUM (EQ 125MG BASE/5ML)ORALFOR SOLUTIONFalsePENICILLIN V POTASSIUM
19ANDA061758_001discontinuedPENICILLIN V POTASSIUM (EQ 125MG BASE/5ML)ORALFOR SOLUTIONFalsePENICILLIN V POTASSIUM
20ANDA061758_002discontinuedPENICILLIN V POTASSIUM (EQ 250MG BASE/5ML)ORALFOR SOLUTIONFalsePENICILLIN V POTASSIUM
21ANDA061815_001discontinuedPENICILLIN V POTASSIUM (EQ 125MG BASE/5ML)ORALFOR SOLUTIONFalsePFIZERPEN VK
22ANDA061815_002discontinuedPENICILLIN V POTASSIUM (EQ 250MG BASE/5ML)ORALFOR SOLUTIONFalsePFIZERPEN VK
23ANDA062002_001discontinuedPENICILLIN V POTASSIUM (EQ 125MG BASE/5ML)ORALFOR SOLUTIONFalsePENAPAR-VK
24ANDA062002_002discontinuedPENICILLIN V POTASSIUM (EQ 250MG BASE/5ML)ORALFOR SOLUTIONFalsePENAPAR-VK
25ANDA062153_001discontinuedPENICILLIN V POTASSIUM (EQ 125MG BASE/5ML)ORALFOR SOLUTIONFalseVEETIDS '125'
26ANDA062153_002discontinuedPENICILLIN V POTASSIUM (EQ 250MG BASE/5ML)ORALFOR SOLUTIONFalseVEETIDS '125'
27ANDA062270_001discontinuedPENICILLIN V POTASSIUM (EQ 125MG BASE/5ML)ORALFOR SOLUTIONFalseBEEPEN-VK
28ANDA062270_002discontinuedPENICILLIN V POTASSIUM (EQ 250MG BASE/5ML)ORALFOR SOLUTIONFalseBEEPEN-VK
29ANDA062981_001RXPENICILLIN V POTASSIUM (EQ 125MG BASE/5ML)ORALFOR SOLUTIONFalseAA1989-02-10PENICILLIN V POTASSIUM
30ANDA062981_002RXPENICILLIN V POTASSIUM (EQ 250MG BASE/5ML)ORALFOR SOLUTIONFalseAA1989-02-10PENICILLIN V POTASSIUM

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
12bfee83c-4f38-440e-9061-58036490d009 (view SPL)PENICILLIN V POTASSIUM TABLETS, USP / PENICILLIN V POTASSIUM FOR ORAL SOLUTION, USP1172117441254127Rx onlyprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2012-02-153548681780, 548684125
23111ca84-6f8e-45ea-91a1-9cb99c63607e (view SPL)PENICILLIN V POTASSIUM TABLETS, USP PENICILLIN V POTASSIUM FOR ORAL SOLUTION, USP 1172 1174 4125 4127prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2014-12-038000934125, 000934127, 000931172, 000931174Penicillin V Oral Tablet
3316aa904-09f1-4a8e-9adf-93cfc14f9a0a (view SPL)PENICILLIN V POTASSIUM TABLETS, USP PENICILLIN V POTASSIUM FOR ORAL SOLUTION, USP 4127prescriptionHuman PrescriptionProficient Rx LpRELABEL2015-02-011631870533
43c6d4fc6-1753-4d81-8284-c9c81e7bf646 (view SPL)PENICILLIN V POTASSIUM TABLETS, USP / PENICILLIN V POTASSIUM FOR ORAL SOLUTION, USP1172117441254127Rx onlyprescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-06-201545692935
58c342c78-47fb-4f6b-9451-68b1f752555c (view SPL)PENICILLIN V POTASSIUM TABLETS, USP / PENICILLIN V POTASSIUM FOR ORAL SOLUTION, USP1172117441254127Rx onlyprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2013-05-162687889852, 687889853
6d291f309-1a61-4e32-a684-5b32e7bcb518 (view SPL)PENICILLIN V POTASSIUM TABLETS, USP / PENICILLIN V POTASSIUM FOR ORAL SOLUTION, USPRx onlyprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-11-101216950559, 216950772
7d6417642-66c5-48b5-86bf-ffb87c4250ac (view SPL)Penicillin V Potassium Tablets, USP - 250 mg and 500 mg Penicillin V Potassium for Oral Solution, USP - 125 mg/5 mL and 250 mg/5 mL Rx OnlyprescriptionHuman PrescriptionDava Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2014-04-012672530202, 672530203, 672530200, 672530201Penicillin V Oral Tablet
8f1070e7c-a9a0-4a08-baf6-dc1cab3648ef (view SPL)PENICILLIN V POTASSIUM TABLETS, USP / PENICILLIN V POTASSIUM FOR ORAL SOLUTION, USP1172117441254127Rx onlyprescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-06-201545692933

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