Ampicillin Oral Capsule

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Dava Pharmaceuticals, Inc. (2015-08-06)
Oldest Current Product
1988-02-25
License(s)
ANDA
RxNORM
ORAL CAPSULE\AMPICILLIN
FDAOB
ORAL\CAPSULE\AMPICILLIN/AMPICILLIN TRIHYDRATE
SPL Active
ORAL\CAPSULE\AMPICILLIN TRIHYDRATE
SPL Moiety
ORAL\CAPSULE\AMPICILLIN

product(s) by strength(s)

ampicillin 250 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007812144ANDASandoz Inc1995-08-29AMPICILLIN TRIHYDRATEORALCAPSULEANDA0640820a66c5c3-63bf-46e3-835e-26b555ab6954
2672530180ANDADava Pharmaceuticals, Inc.1988-02-25AMPICILLIN TRIHYDRATEORALCAPSULEANDA0628821422ac93-067c-489b-9b95-17cd00303f4c

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1552890023ANDAPd-Rx Pharmaceuticals, Inc.1995-08-29AMPICILLIN TRIHYDRATEORALCAPSULE007812144ANDA0640820cd21d3f-773d-44f6-b923-eb225a95ee93
2604290023ANDAGolden State Medical Supply, Inc.1988-02-25AMPICILLIN TRIHYDRATEORALCAPSULE672530180ANDA06288347bb7111-ea36-442f-ae41-6e28380fc19a

ampicillin 500 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007812145ANDASandoz Inc1995-08-29AMPICILLIN TRIHYDRATEORALCAPSULEANDA0640820a66c5c3-63bf-46e3-835e-26b555ab6954
2672530181ANDADava Pharmaceuticals, Inc.1988-02-25AMPICILLIN TRIHYDRATEORALCAPSULEANDA0628821422ac93-067c-489b-9b95-17cd00303f4c

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1105440122ANDABlenheim Pharmacal, Inc.2010-03-30AMPICILLIN TRIHYDRATEORALCAPSULE672530181ANDA062882116d482a-f6e8-6130-e054-00144ff88e88
2529590389ANDAH.J. Harkins Company, Inc.1988-02-25AMPICILLIN TRIHYDRATEORALCAPSULE672530181ANDA062882e6040d92-0b8f-4808-a375-eece4aeeff18
3545692411ANDAA-S Medication Solutions Llc1988-02-25AMPICILLIN TRIHYDRATEORALCAPSULE672530181ANDA062882be35570c-239f-4320-bbcd-58971810943f
4548683113ANDAPhysicians Total Care, Inc.2011-03-22AMPICILLIN TRIHYDRATEORALCAPSULE007812145ANDA0640823b49ec7f-e511-4d98-857b-94a006027792
5552890024ANDAPd-Rx Pharmaceuticals, Inc.1988-02-25AMPICILLIN TRIHYDRATEORALCAPSULE672530181ANDA0628820d237da2-2e04-4e7e-86e1-ed1a86f7df1e
6604290024ANDAGolden State Medical Supply, Inc.1988-02-25AMPICILLIN TRIHYDRATEORALCAPSULE672530181ANDA06288247bb7111-ea36-442f-ae41-6e28380fc19a

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA060060TOTACILLINTrueGLAXOSMITHKLINEANDA060060_001, ANDA060060_002
2ANDA060624OMNIPEN (AMPICILLIN)TrueWYETH AYERST LABORATORIESANDA060624_001, ANDA060624_002
3ANDA060765AMPICILLIN TRIHYDRATETrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USAANDA060765_001, ANDA060765_002
4ANDA060908PENBRITINTrueWYETH AYERST LABORATORIESANDA060908_001, ANDA060908_002
5ANDA061387AMPICILLIN TRIHYDRATETrueVITARINE PHARMACEUTICALS INCANDA061387_001, ANDA061387_003
6ANDA061392PRINCIPENTrueBRISTOL MYERS SQUIBB COANDA061392_001, ANDA061392_002
7ANDA061502AMPICILLIN TRIHYDRATETrueTEVA PHARMACEUTICALS USA INCANDA061502_001, ANDA061502_002
8ANDA061602AMPICILLIN TRIHYDRATETrueAMERICAN ANTIBIOTICS LLCANDA061602_001, ANDA061602_002
9ANDA061755AMPICILLIN TRIHYDRATETrueMYLAN PHARMACEUTICALS INCANDA061755_001, ANDA061755_002
10ANDA061853AMPICILLIN TRIHYDRATETruePUREPAC PHARMACEUTICAL COANDA061853_001, ANDA061853_002
11ANDA062041AMCILLTruePARKE DAVIS DIV WARNER LAMBERT COANDA062041_001, ANDA062041_002
12ANDA062050PFIZERPEN-ATruePFIZER LABORATORIES DIV PFIZER INCANDA062050_001, ANDA062050_002
13ANDA062157PRINCIPEN '250'TrueAPOTHECON SUB BRISTOL MYERS SQUIBB COANDA062157_001, ANDA062157_002
14ANDA062208AMPICILLIN TRIHYDRATETrueLEDERLE LABORATORIES DIV AMERICAN CYANAMID COANDA062208_001, ANDA062208_002
15ANDA062212TOTACILLINTrueGLAXOSMITHKLINEANDA062212_001, ANDA062212_002
16ANDA062882AMPICILLIN TRIHYDRATEDAVA PHARMACEUTICALS INC1988-02-25ANDA062882_001
17ANDA062883AMPICILLIN TRIHYDRATEDAVA PHARMACEUTICALS INC1988-02-25ANDA062883_001
18ANDA062888PRINCIPENTrueAPOTHECON INC DIV BRISTOL MYERS SQUIBB1988-03-04ANDA062888_001, ANDA062888_002
19ANDA064082AMPICILLIN TRIHYDRATESANDOZ INC1995-08-29ANDA064082_001, ANDA064082_002
20NDA050056PRINCIPEN '250'TrueAPOTHECON SUB BRISTOL MYERS SQUIBB CONDA050056_001, NDA050056_002
21NDA050310POLYCILLINTrueBRISTOL LABORATORIES INC DIV BRISTOL MYERS CONDA050310_001, NDA050310_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA060060_001discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 250MG BASE)ORALCAPSULEFalseTOTACILLIN
2ANDA060060_002discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 500MG BASE)ORALCAPSULEFalseTOTACILLIN
3ANDA060624_001discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (250MG)ORALCAPSULEFalseOMNIPEN (AMPICILLIN)
4ANDA060624_002discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (500MG)ORALCAPSULEFalseOMNIPEN (AMPICILLIN)
5ANDA060765_001discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 250MG BASE)ORALCAPSULEFalseAMPICILLIN TRIHYDRATE
6ANDA060765_002discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 500MG BASE)ORALCAPSULEFalseAMPICILLIN TRIHYDRATE
7ANDA060908_001discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 250MG BASE)ORALCAPSULEFalsePENBRITIN
8ANDA060908_002discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 500MG BASE)ORALCAPSULEFalsePENBRITIN
9ANDA061387_001discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 250MG BASE)ORALCAPSULEFalseAMPICILLIN TRIHYDRATE
10ANDA061387_003discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 500MG BASE)ORALCAPSULEFalseAMPICILLIN TRIHYDRATE
11ANDA061392_001discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 250MG BASE)ORALCAPSULEFalsePRINCIPEN
12ANDA061392_002discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 500MG BASE)ORALCAPSULEFalsePRINCIPEN
13ANDA061502_001discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 250MG BASE)ORALCAPSULEFalseAMPICILLIN TRIHYDRATE
14ANDA061502_002discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 500MG BASE)ORALCAPSULEFalseAMPICILLIN TRIHYDRATE
15ANDA061602_001discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 250MG BASE)ORALCAPSULEFalseAMPICILLIN TRIHYDRATE
16ANDA061602_002discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 500MG BASE)ORALCAPSULEFalseAMPICILLIN TRIHYDRATE
17ANDA061755_001discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 250MG BASE)ORALCAPSULEFalseAMPICILLIN TRIHYDRATE
18ANDA061755_002discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 500MG BASE)ORALCAPSULEFalseAMPICILLIN TRIHYDRATE
19ANDA061853_001discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 250MG BASE)ORALCAPSULEFalseAMPICILLIN TRIHYDRATE
20ANDA061853_002discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 500MG BASE)ORALCAPSULEFalseAMPICILLIN TRIHYDRATE
21ANDA062041_001discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 250MG BASE)ORALCAPSULEFalseAMCILL
22ANDA062041_002discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 500MG BASE)ORALCAPSULEFalseAMCILL
23ANDA062050_001discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 250MG BASE)ORALCAPSULEFalsePFIZERPEN-A
24ANDA062050_002discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 500MG BASE)ORALCAPSULEFalsePFIZERPEN-A
25ANDA062157_001discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 500MG BASE)ORALCAPSULEFalsePRINCIPEN '250'
26ANDA062157_002discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 250MG BASE)ORALCAPSULEFalsePRINCIPEN '250'
27ANDA062208_001discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 250MG BASE)ORALCAPSULEFalseAMPICILLIN TRIHYDRATE
28ANDA062208_002discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 500MG BASE)ORALCAPSULEFalseAMPICILLIN TRIHYDRATE
29ANDA062212_001discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 250MG BASE)ORALCAPSULEFalseTOTACILLIN
30ANDA062212_002discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 500MG BASE)ORALCAPSULEFalseTOTACILLIN
31ANDA062882_001RXAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 500MG BASE)ORALCAPSULETrueAB1988-02-25AMPICILLIN TRIHYDRATE
32ANDA062883_001RXAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 250MG BASE)ORALCAPSULEFalseAB1988-02-25AMPICILLIN TRIHYDRATE
33ANDA062888_001discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 250MG BASE)ORALCAPSULEFalse1988-03-04PRINCIPEN
34ANDA062888_002discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 500MG BASE)ORALCAPSULEFalse1988-03-04PRINCIPEN
35ANDA064082_001RXAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 250MG BASE)ORALCAPSULEFalseAB1995-08-29AMPICILLIN TRIHYDRATE
36ANDA064082_002RXAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 500MG BASE)ORALCAPSULEFalseAB1995-08-29AMPICILLIN TRIHYDRATE
37NDA050056_001discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 250MG BASE)ORALCAPSULEFalsePRINCIPEN '250'
38NDA050056_002discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 500MG BASE)ORALCAPSULEFalsePRINCIPEN '250'
39NDA050310_001discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 250MG BASE)ORALCAPSULEFalsePOLYCILLIN
40NDA050310_002discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 500MG BASE)ORALCAPSULEFalsePOLYCILLIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
10a66c5c3-63bf-46e3-835e-26b555ab6954 (view SPL)Ampicillin Capsules, USPprescriptionHuman PrescriptionSandoz Inc2015-08-0412007812144, 007812145
20cd21d3f-773d-44f6-b923-eb225a95ee93 (view SPL)Ampicillin Capsules, USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2012-01-2411552890023
30d237da2-2e04-4e7e-86e1-ed1a86f7df1e (view SPL)AMPICILLIN CAPSULES, USP 250 mg and 500 mgAMPICILLIN FOR ORAL SUSPENSION, USP 125 mg/5 mL and 250 mg/5 mLRx OnlyprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-01-262552890024
4116d482a-f6e8-6130-e054-00144ff88e88 (view SPL)AMPICILLIN CAPSULES, USP 250 mg and 500 mg AMPICILLIN FOR ORAL SUSPENSION, USP 125 mg/5 mL and 250 mg/5 mL Rx OnlyprescriptionHuman PrescriptionBlenheim Pharmacal, Inc.relabel2015-03-161105440122
51422ac93-067c-489b-9b95-17cd00303f4c (view SPL)AMPICILLIN CAPSULES, USP 250 mg and 500 mgAMPICILLIN FOR ORAL SUSPENSION, USP 125 mg/5 mL and 250 mg/5 mLRx OnlyprescriptionHuman PrescriptionDava Pharmaceuticals, Inc.ANALYSIS, MANUFACTURE, PACK2015-08-064672530180, 672530181, 672530182, 672530183Ampicillin Oral Suspension
63b49ec7f-e511-4d98-857b-94a006027792 (view SPL)Ampicillin Capsules, USPprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-06-051548683113
747bb7111-ea36-442f-ae41-6e28380fc19a (view SPL)Ampicillin Capsules, USPprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2011-07-011604290023, 604290024
8be35570c-239f-4320-bbcd-58971810943f (view SPL)AMPICILLIN CAPSULES, USP 250 mg and 500 mgAMPICILLIN FOR ORAL SUSPENSION, USP 125 mg/5 mL and 250 mg/5 mLRx OnlyprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2013-06-201545692411
9e6040d92-0b8f-4808-a375-eece4aeeff18 (view SPL)AMPICILLIN CAPSULES, USP 500 mgRx OnlyprescriptionHuman PrescriptionH.J. Harkins Company, Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2012-08-281529590389

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