Fosinopril Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Teva Pharmaceuticals Usa Inc (2013-08-14)
Oldest Current Product
2003-12-01
License(s)
ANDA
RxNORM
ORAL TABLET\FOSINOPRIL
FDAOB
ORAL\TABLET\FOSINOPRIL SODIUM
SPL Active
ORAL\TABLET\FOSINOPRIL SODIUM
SPL Moiety
ORAL\TABLET\FOSINOPRIL
ORAL\TABLET\FOSINOPRILAT

product(s) by strength(s)

fosinopril sodium 10 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000937222ANDATeva Pharmaceuticals Usa Inc2003-12-01FOSINOPRIL SODIUMORALTABLETANDA0761393c91edcd-b11a-4289-a1c5-d5054b18f54d
2001850041ANDAEon Labs, Inc.2004-04-23FOSINOPRIL SODIUMORALTABLETANDA076483b3948f79-00bd-4119-a3ba-4414eced1534
3317220200ANDACamber Pharmaceuticals, Inc.2007-09-17FOSINOPRIL SODIUMORALTABLETANDA077222aa425a18-9d34-4b3b-9ef8-fbff79471686
4605052510ANDAApotex Corp2005-05-18FOSINOPRIL SODIUMORALTABLETANDA076906eaa753e8-9fda-af0b-9d54-bdf0d1674832
5658620471ANDAAurobindo Pharma Limited2011-03-30FOSINOPRIL SODIUMORALTABLETANDA091163aee04f17-8ee9-42f5-861f-b6ba17220ca4
6762820200ANDAExelan Pharmaceuticals Inc.2005-06-21FOSINOPRIL SODIUMORALTABLETANDA077222e2ff3171-a17a-456a-9272-ca1682b01d19

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685064ANDAPhysicians Total Care, Inc.2004-05-18FOSINOPRIL SODIUMORALTABLET000937222ANDA076139e8c794ba-8a15-4e3e-ba3b-1704887628cd
2604290234ANDAGolden State Medical Supply, Inc.2011-12-27FOSINOPRIL SODIUMORALTABLET605052510ANDA076906746e3cfb-2a58-4e4b-be14-de2bcdd32b18
3636295279ANDABryant Ranch Prepack2007-09-17FOSINOPRIL SODIUMORALTABLET317220200ANDA077222835c13d6-c3af-498d-9011-325d34006daf

fosinopril sodium 20 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000937223ANDATeva Pharmaceuticals Usa Inc2003-12-01FOSINOPRIL SODIUMORALTABLETANDA0761393c91edcd-b11a-4289-a1c5-d5054b18f54d
2001850042ANDAEon Labs, Inc.2004-04-23FOSINOPRIL SODIUMORALTABLETANDA076483b3948f79-00bd-4119-a3ba-4414eced1534
3317220201ANDACamber Pharmaceuticals, Inc.2007-09-17FOSINOPRIL SODIUMORALTABLETANDA077222aa425a18-9d34-4b3b-9ef8-fbff79471686
4605052511ANDAApotex Corp2005-05-18FOSINOPRIL SODIUMORALTABLETANDA076906eaa753e8-9fda-af0b-9d54-bdf0d1674832
5658620472ANDAAurobindo Pharma Limited2011-03-30FOSINOPRIL SODIUMORALTABLETANDA091163aee04f17-8ee9-42f5-861f-b6ba17220ca4
6762820201ANDAExelan Pharmaceuticals Inc.2005-06-21FOSINOPRIL SODIUMORALTABLETANDA077222e2ff3171-a17a-456a-9272-ca1682b01d19

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1353560961ANDALake Erie Medical Dba Quality Care Products Llc2004-04-23FOSINOPRIL SODIUMORALTABLET001850042ANDA0764836476b0c2-cbc4-45f8-9168-4f0c0267388d
2504363138ANDAUnit Dose Services2007-09-17FOSINOPRIL SODIUMORALTABLET317220201ANDA0772221cd8aac4-c59a-460d-97d7-ba3b80e0ab82
3548685055ANDAPhysicians Total Care, Inc.2004-04-27FOSINOPRIL SODIUMORALTABLET000937223ANDA076139e8c794ba-8a15-4e3e-ba3b-1704887628cd
4604290235ANDAGolden State Medical Supply, Inc.2011-12-27FOSINOPRIL SODIUMORALTABLET605052511ANDA076906746e3cfb-2a58-4e4b-be14-de2bcdd32b18
5607600428ANDASt Marys Medical Park Pharmacy2014-04-21FOSINOPRIL SODIUMORALTABLET317220201ANDA07722222ad0f70-9b7d-4d60-9bd3-aa4ccad24712
6675440322ANDAAphena Pharma Solutions - Tennessee, Inc.2004-04-23FOSINOPRIL SODIUMORALTABLET001850042ANDA076483e9838e99-b802-457f-aa90-cc39993d3b13
7675440431ANDAAphena Pharma Solutions - Tennessee, Inc.2005-06-21FOSINOPRIL SODIUMORALTABLET762820201ANDA0772220524fc86-caae-4d95-8a65-551ce99637e8
8682586106ANDADispensing Solutions, Inc.2004-04-23FOSINOPRIL SODIUMORALTABLET001850042ANDA076483eccfed1e-64ac-4d80-9ab3-bf985a6b8a78

fosinopril sodium 40 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000937224ANDATeva Pharmaceuticals Usa Inc2003-12-01FOSINOPRIL SODIUMORALTABLETANDA0761393c91edcd-b11a-4289-a1c5-d5054b18f54d
2001850047ANDAEon Labs, Inc.2004-04-23FOSINOPRIL SODIUMORALTABLETANDA076483b3948f79-00bd-4119-a3ba-4414eced1534
3317220202ANDACamber Pharmaceuticals, Inc.2007-09-17FOSINOPRIL SODIUMORALTABLETANDA077222aa425a18-9d34-4b3b-9ef8-fbff79471686
4605052512ANDAApotex Corp2005-05-18FOSINOPRIL SODIUMORALTABLETANDA076906eaa753e8-9fda-af0b-9d54-bdf0d1674832
5658620473ANDAAurobindo Pharma Limited2011-03-30FOSINOPRIL SODIUMORALTABLETANDA091163aee04f17-8ee9-42f5-861f-b6ba17220ca4
6762820202ANDAExelan Pharmaceuticals Inc.2005-06-21FOSINOPRIL SODIUMORALTABLETANDA077222e2ff3171-a17a-456a-9272-ca1682b01d19

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1433530870ANDAAphena Pharma Solutions - Tennessee, Llc2005-06-21FOSINOPRIL SODIUMORALTABLET762820202ANDA07722241d4f5a7-8477-4f31-834a-29457b33ee41
2504360274ANDAUnit Dose Services2007-09-17FOSINOPRIL SODIUMORALTABLET317220202ANDA0772222f122ad0-f9c2-4c90-a94b-072354b876b5
3548685182ANDAPhysicians Total Care, Inc.2004-11-18FOSINOPRIL SODIUMORALTABLET000937224ANDA076139e8c794ba-8a15-4e3e-ba3b-1704887628cd
4604290236ANDAGolden State Medical Supply, Inc.2011-12-27FOSINOPRIL SODIUMORALTABLET605052512ANDA076906746e3cfb-2a58-4e4b-be14-de2bcdd32b18
5607600429ANDASt Marys Medical Park Pharmacy2014-05-22FOSINOPRIL SODIUMORALTABLET000937224ANDA0761398d02339b-33c3-40ea-ab3b-5b659069a4ff
6675440306ANDAAphena Pharma Solutions - Tennessee, Inc.2004-04-23FOSINOPRIL SODIUMORALTABLET001850047ANDA076483e9838e99-b802-457f-aa90-cc39993d3b13

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA076139FOSINOPRIL SODIUMTEVA PHARMACEUTICALS USA INC2003-11-25ANDA076139_001, ANDA076139_002, ANDA076139_003
2ANDA076188FOSINOPRIL SODIUMTrueSANDOZ INC2004-10-08ANDA076188_001, ANDA076188_002, ANDA076188_003
3ANDA076483FOSINOPRIL SODIUMSANDOZ INC2004-04-23ANDA076483_001, ANDA076483_002, ANDA076483_003
4ANDA076580FOSINOPRIL SODIUMTrueRANBAXY LABORATORIES LTD2004-04-23ANDA076580_001, ANDA076580_002, ANDA076580_003
5ANDA076620FOSINOPRIL SODIUMACTAVIS LABORATORIES FL INC2004-10-15ANDA076620_001, ANDA076620_002, ANDA076620_003
6ANDA076906FOSINOPRIL SODIUMAPOTEX INC ETOBICOKE SITE2005-05-17ANDA076906_001, ANDA076906_002, ANDA076906_003
7ANDA076987FOSINOPRIL SODIUMTrueWATSON LABORATORIES INC2004-12-23ANDA076987_001, ANDA076987_002, ANDA076987_003
8ANDA077222FOSINOPRIL SODIUMINVAGEN PHARMACEUTICALS INC2005-04-20ANDA077222_001, ANDA077222_002, ANDA077222_003
9ANDA077531FOSINOPRIL SODIUMTrueWATSON LABORATORIES INC2006-08-31ANDA077531_001, ANDA077531_002, ANDA077531_003
10ANDA091163FOSINOPRIL SODIUMAUROBINDO PHARMA LIMITED2011-03-30ANDA091163_001, ANDA091163_002, ANDA091163_003
11NDA019915MONOPRILTrueBRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE1991-05-16NDA019915_002, NDA019915_003, NDA019915_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076139_001RXFOSINOPRIL SODIUM (10MG)ORALTABLETFalseAB2003-11-25FOSINOPRIL SODIUM
2ANDA076139_002RXFOSINOPRIL SODIUM (20MG)ORALTABLETFalseAB2003-11-25FOSINOPRIL SODIUM
3ANDA076139_003RXFOSINOPRIL SODIUM (40MG)ORALTABLETTrueAB2003-11-25FOSINOPRIL SODIUM
4ANDA076188_001discontinuedFOSINOPRIL SODIUM (10MG)ORALTABLETFalse2004-10-08FOSINOPRIL SODIUM
5ANDA076188_002discontinuedFOSINOPRIL SODIUM (20MG)ORALTABLETFalse2004-10-08FOSINOPRIL SODIUM
6ANDA076188_003discontinuedFOSINOPRIL SODIUM (40MG)ORALTABLETFalse2004-10-08FOSINOPRIL SODIUM
7ANDA076483_001RXFOSINOPRIL SODIUM (10MG)ORALTABLETFalseAB2004-04-23FOSINOPRIL SODIUM
8ANDA076483_002RXFOSINOPRIL SODIUM (20MG)ORALTABLETFalseAB2004-04-23FOSINOPRIL SODIUM
9ANDA076483_003RXFOSINOPRIL SODIUM (40MG)ORALTABLETFalseAB2004-04-23FOSINOPRIL SODIUM
10ANDA076580_001discontinuedFOSINOPRIL SODIUM (10MG)ORALTABLETFalse2004-04-23FOSINOPRIL SODIUM
11ANDA076580_002discontinuedFOSINOPRIL SODIUM (20MG)ORALTABLETFalse2004-04-23FOSINOPRIL SODIUM
12ANDA076580_003discontinuedFOSINOPRIL SODIUM (40MG)ORALTABLETFalse2004-04-23FOSINOPRIL SODIUM
13ANDA076620_001RXFOSINOPRIL SODIUM (10MG)ORALTABLETFalseAB2004-10-15FOSINOPRIL SODIUM
14ANDA076620_002RXFOSINOPRIL SODIUM (20MG)ORALTABLETFalseAB2004-10-15FOSINOPRIL SODIUM
15ANDA076620_003RXFOSINOPRIL SODIUM (40MG)ORALTABLETFalseAB2004-10-15FOSINOPRIL SODIUM
16ANDA076906_001RXFOSINOPRIL SODIUM (10MG)ORALTABLETFalseAB2005-05-17FOSINOPRIL SODIUM
17ANDA076906_002RXFOSINOPRIL SODIUM (20MG)ORALTABLETFalseAB2005-05-17FOSINOPRIL SODIUM
18ANDA076906_003RXFOSINOPRIL SODIUM (40MG)ORALTABLETFalseAB2005-05-17FOSINOPRIL SODIUM
19ANDA076987_001discontinuedFOSINOPRIL SODIUM (10MG)ORALTABLETFalse2004-12-23FOSINOPRIL SODIUM
20ANDA076987_002discontinuedFOSINOPRIL SODIUM (20MG)ORALTABLETFalse2004-12-23FOSINOPRIL SODIUM
21ANDA076987_003discontinuedFOSINOPRIL SODIUM (40MG)ORALTABLETFalse2004-12-23FOSINOPRIL SODIUM
22ANDA077222_001RXFOSINOPRIL SODIUM (10MG)ORALTABLETFalseAB2005-04-20FOSINOPRIL SODIUM
23ANDA077222_002RXFOSINOPRIL SODIUM (20MG)ORALTABLETFalseAB2005-04-20FOSINOPRIL SODIUM
24ANDA077222_003RXFOSINOPRIL SODIUM (40MG)ORALTABLETFalseAB2005-04-20FOSINOPRIL SODIUM
25ANDA077531_001discontinuedFOSINOPRIL SODIUM (10MG)ORALTABLETFalse2006-08-31FOSINOPRIL SODIUM
26ANDA077531_002discontinuedFOSINOPRIL SODIUM (20MG)ORALTABLETFalse2006-08-31FOSINOPRIL SODIUM
27ANDA077531_003discontinuedFOSINOPRIL SODIUM (40MG)ORALTABLETFalse2006-08-31FOSINOPRIL SODIUM
28ANDA091163_001RXFOSINOPRIL SODIUM (10MG)ORALTABLETFalseAB2011-03-30FOSINOPRIL SODIUM
29ANDA091163_002RXFOSINOPRIL SODIUM (20MG)ORALTABLETFalseAB2011-03-30FOSINOPRIL SODIUM
30ANDA091163_003RXFOSINOPRIL SODIUM (40MG)ORALTABLETFalseAB2011-03-30FOSINOPRIL SODIUM
31NDA019915_002discontinuedFOSINOPRIL SODIUM (10MG)ORALTABLETFalse1991-05-16MONOPRIL
32NDA019915_003discontinuedFOSINOPRIL SODIUM (20MG)ORALTABLETFalse1991-05-16MONOPRIL
33NDA019915_004discontinuedFOSINOPRIL SODIUM (40MG)ORALTABLETFalse1995-03-28MONOPRIL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10524fc86-caae-4d95-8a65-551ce99637e8 (view SPL)Rx onlyprescriptionHuman PrescriptionAphena Pharma Solutions - Tennessee, Inc.Repack2014-07-162675440431
21cd8aac4-c59a-460d-97d7-ba3b80e0ab82 (view SPL)FOSINOPRIL SODIUM TABLETS 10 mg, 20 mg and 40 mg Rx onlyprescriptionHuman PrescriptionUnit Dose ServicesREPACK2011-01-252504363138
322ad0f70-9b7d-4d60-9bd3-aa4ccad24712 (view SPL)FOSINOPRIL SODIUM TABLETSprescriptionHuman PrescriptionSt Marys Medical Park PharmacyMANUFACTURE, relabel, repack2014-04-211607600428
42f122ad0-f9c2-4c90-a94b-072354b876b5 (view SPL)FOSINOPRIL SODIUM TABLETS 10 mg, 20 mg and 40 mg Rx onlyprescriptionHuman PrescriptionUnit Dose ServicesREPACK2011-01-252504360274
53c91edcd-b11a-4289-a1c5-d5054b18f54d (view SPL)FOSINOPRIL SODIUM TABLETS USP, 10 mg, 20 mg, and 40 mg 722272237224Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2013-08-146000937222, 000937223, 000937224
641d4f5a7-8477-4f31-834a-29457b33ee41 (view SPL)Rx onlyprescriptionHuman PrescriptionAphena Pharma Solutions - Tennessee, LlcRepack2014-07-162433530870
76476b0c2-cbc4-45f8-9168-4f0c0267388d (view SPL)Fosinopril Sodium TabletsprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2013-05-231353560961
8746e3cfb-2a58-4e4b-be14-de2bcdd32b18 (view SPL)Fosinopril Sodium TabletsprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2013-01-032604290234, 604290235, 604290236
9835c13d6-c3af-498d-9011-325d34006daf (view SPL)FOSINOPRIL SODIUM TABLETS 10 mg, 20 mg and 40 mg Rx onlyprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-05-151000636295279
108d02339b-33c3-40ea-ab3b-5b659069a4ff (view SPL)FOSINOPRIL SODIUM TABLETS USP 40 mg 7224Rx onlyprescriptionHuman PrescriptionSt Marys Medical Park Pharmacymanufacture, relabel, repack2014-05-221607600429
11aa425a18-9d34-4b3b-9ef8-fbff79471686 (view SPL)FOSINOPRIL SODIUM TABLETS 10 mg, 20 mg and 40 mg Rx onlyprescriptionHuman PrescriptionCamber Pharmaceuticals, Inc.ANALYSIS, MANUFACTURE2011-01-251317220200, 317220201, 317220202
12aee04f17-8ee9-42f5-861f-b6ba17220ca4 (view SPL)Fosinopril Sodium Tablets, USPRx onlyprescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2013-11-145658620471, 658620472, 658620473
13b3948f79-00bd-4119-a3ba-4414eced1534 (view SPL)Fosinopril Sodium TabletsprescriptionHuman PrescriptionEon Labs, Inc.2013-12-0415001850041, 001850042, 001850047
14e2ff3171-a17a-456a-9272-ca1682b01d19 (view SPL)Rx onlyprescriptionHuman PrescriptionExelan Pharmaceuticals Inc.ANALYSIS, MANUFACTURE2014-04-042762820200, 762820201, 762820202
15e8c794ba-8a15-4e3e-ba3b-1704887628cd (view SPL)FOSINOPRIL SODIUM TABLETS USP, 10 mg, 20 mg, and 40 mg 722272237224Rx onlyprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2013-02-052548685055, 548685064, 548685182
16e9838e99-b802-457f-aa90-cc39993d3b13 (view SPL)Fosinopril Sodium TabletsprescriptionHuman PrescriptionAphena Pharma Solutions - Tennessee, Inc.Repack2012-07-171675440306, 675440322
17eaa753e8-9fda-af0b-9d54-bdf0d1674832 (view SPL)FOSINOPRIL Na TABLETS, USP Rx Only (Fosinopril Sodium Tablets)prescriptionHuman PrescriptionApotex Corp2013-11-212605052510, 605052511, 605052512
18eccfed1e-64ac-4d80-9ab3-bf985a6b8a78 (view SPL)Fosinopril Sodium TabletsprescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2013-07-225682586106

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