Methyldopa Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mylan Pharmaceuticals Inc. (2015-05-14)
Oldest Current Product
1984-02-20
License(s)
ANDA
RxNORM
ORAL TABLET\METHYLDOPA
FDAOB
ORAL\TABLET\METHYLDOPA
SPL Active
ORAL\TABLET, FILM COATED\METHYLDOPA
ORAL\TABLET\METHYLDOPA
SPL Moiety
ORAL\TABLET, FILM COATED\METHYLDOPA
ORAL\TABLET, FILM COATED\METHYLDOPA ANHYDROUS
ORAL\TABLET, FILM COATED\METHYLDOPA: METHYLDOPA ANHYDROUS
ORAL\TABLET\METHYLDOPA ANHYDROUS

product(s) by strength(s)

invalid application product(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1167290029ANDAAccord Healthcare Inc.2012-06-272012-06-27METHYLDOPAORALTABLET, FILM COATEDANDA07007000206aae-7db1-4ae9-8500-b03fd6788d74

methyldopa 250 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000932931ANDATeva Pharmaceuticals Usa Inc2009-02-23METHYLDOPAORALTABLET, FILM COATEDANDA070098916d802c-91b6-4015-9e57-7ebf7e9bb5ee
2003780611ANDAMylan Pharmaceuticals Inc.1985-04-18METHYLDOPAORALTABLETANDA070076bb1c7c3f-9e6f-4d0e-aea1-6974558659ef
3167290030ANDAAccord Healthcare Inc.2012-06-27METHYLDOPAORALTABLET, FILM COATEDANDA07008400206aae-7db1-4ae9-8500-b03fd6788d74

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950879ANDARebel Distributors Corp1984-02-20METHYLDOPAORALTABLET, FILM COATED001722931ANDA07009860a57abf-9487-4093-9709-40f05755e7b1
2422540351ANDARebel Distributors Corp2009-02-23METHYLDOPAORALTABLET, FILM COATED000932931ANDA070098fa1c61c2-7e24-40ff-916e-456b8725a5cd
3510790200ANDAMylan Institutional Inc.1998-09-01METHYLDOPAORALTABLET003780611ANDA070076227291e5-9baa-476a-93b8-b2142e61a4fe
4521250113ANDARemedyrepack Inc.2012-09-25METHYLDOPAORALTABLET000932931ANDA0700984eb98b20-561d-453d-8f64-88d1e60faff6
5548680050ANDAPhysicians Total Care, Inc.1995-08-29METHYLDOPAORALTABLET, FILM COATED000932931ANDA070098c8bea68b-3932-4538-b568-a296a8817291
6551545093ANDACardinal Health2011-08-23METHYLDOPAORALTABLET510790200ANDA070076d87d63fd-48f7-4130-af03-5e263c338fe4

methyldopa 500 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000932932ANDATeva Pharmaceuticals Usa Inc2009-04-28METHYLDOPAORALTABLET, FILM COATEDANDA070343916d802c-91b6-4015-9e57-7ebf7e9bb5ee
2003780421ANDAMylan Pharmaceuticals Inc.1985-04-18METHYLDOPAORALTABLETANDA070076bb1c7c3f-9e6f-4d0e-aea1-6974558659ef
3167290031ANDAAccord Healthcare Inc.2012-06-27METHYLDOPAORALTABLET, FILM COATEDANDA07008500206aae-7db1-4ae9-8500-b03fd6788d74

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950880ANDARebel Distributors Corp1984-02-20METHYLDOPAORALTABLET, FILM COATED001722932ANDA07034360a57abf-9487-4093-9709-40f05755e7b1
2510790201ANDAMylan Institutional Inc.1998-09-01METHYLDOPAORALTABLET003780421ANDA070076227291e5-9baa-476a-93b8-b2142e61a4fe
3545690510ANDAA-S Medication Solutions Llc2009-04-28METHYLDOPAORALTABLET, FILM COATED000932932ANDA070343cac2489b-7aa8-4d30-b2e4-2937a65fa7cf
4548681328ANDAPhysicians Total Care, Inc.1996-07-26METHYLDOPAORALTABLET, FILM COATED000932932ANDA070343c8bea68b-3932-4538-b568-a296a8817291

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA070060METHYLDOPATrueMUTUAL PHARMACEUTICAL CO INC1986-10-09ANDA070060_001
2ANDA070070METHYLDOPATrueACCORD HEALTHCARE INC1985-10-15ANDA070070_003
3ANDA070073METHYLDOPATrueMUTUAL PHARMACEUTICAL CO INC1986-10-09ANDA070073_001
4ANDA070074METHYLDOPATrueMUTUAL PHARMACEUTICAL CO INC1986-10-09ANDA070074_001
5ANDA070076METHYLDOPAMYLAN PHARMACEUTICALS INC1985-04-18ANDA070076_001, ANDA070076_002
6ANDA070084METHYLDOPAACCORD HEALTHCARE INC1985-10-15ANDA070084_001
7ANDA070085METHYLDOPAACCORD HEALTHCARE INC1985-10-15ANDA070085_001
8ANDA070098METHYLDOPAIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA1986-02-20ANDA070098_001
9ANDA070192METHYLDOPATrueROXANE LABORATORIES INC1986-04-25ANDA070192_001
10ANDA070193METHYLDOPATrueROXANE LABORATORIES INC1986-04-25ANDA070193_001
11ANDA070194METHYLDOPATrueROXANE LABORATORIES INC1986-04-25ANDA070194_001
12ANDA070245METHYLDOPATrueWATSON LABORATORIES INC1986-02-25ANDA070245_001
13ANDA070246METHYLDOPATrueWATSON LABORATORIES INC1986-02-25ANDA070246_001
14ANDA070247METHYLDOPATrueWATSON LABORATORIES INC1986-02-25ANDA070247_001
15ANDA070260METHYLDOPATrueWATSON LABORATORIES INC1985-06-24ANDA070260_001
16ANDA070261METHYLDOPATrueWATSON LABORATORIES INC1985-06-24ANDA070261_001
17ANDA070262METHYLDOPATrueWATSON LABORATORIES INC1985-06-24ANDA070262_001
18ANDA070331METHYLDOPATruePARKE DAVIS DIV WARNER LAMBERT CO1986-04-15ANDA070331_001
19ANDA070332METHYLDOPATruePARKE DAVIS DIV WARNER LAMBERT CO1986-04-15ANDA070332_001
20ANDA070333METHYLDOPATruePARKE DAVIS DIV WARNER LAMBERT CO1986-04-15ANDA070333_001
21ANDA070343METHYLDOPAIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA1986-02-20ANDA070343_001
22ANDA070452METHYLDOPATruePUREPAC PHARMACEUTICAL CO1986-02-07ANDA070452_001
23ANDA070535METHYLDOPATruePAR PHARMACEUTICAL INC1987-01-02ANDA070535_001
24ANDA070536METHYLDOPATruePAR PHARMACEUTICAL INC1987-01-02ANDA070536_001
25ANDA070537METHYLDOPATruePAR PHARMACEUTICAL INC1987-01-02ANDA070537_001
26ANDA070625METHYLDOPAWATSON LABORATORIES INC1986-06-06ANDA070625_001
27ANDA070669METHYLDOPATrueSUPERPHARM CORP1989-06-23ANDA070669_001
28ANDA070670METHYLDOPATrueSUPERPHARM CORP1989-06-23ANDA070670_001
29ANDA070703METHYLDOPATrueWATSON LABORATORIES INC1986-06-06ANDA070703_001
30ANDA070749METHYLDOPATruePUREPAC PHARMACEUTICAL CO1986-02-07ANDA070749_001
31ANDA070750METHYLDOPATruePUREPAC PHARMACEUTICAL CO1986-02-07ANDA070750_001
32ANDA071006METHYLDOPATrueDURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC1986-12-16ANDA071006_001
33ANDA071009METHYLDOPATrueDURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC1986-12-16ANDA071009_001
34ANDA071067METHYLDOPATrueTEVA PHARMACEUTICALS USA INC1986-12-05ANDA071067_001
35ANDA071105METHYLDOPATrueTEVA PHARMACEUTICALS USA INC1986-12-05ANDA071105_001
36ANDA071106METHYLDOPATrueTEVA PHARMACEUTICALS USA INC1986-12-05ANDA071106_001
37ANDA071700METHYLDOPATrueSANDOZ INC1988-03-02ANDA071700_001
38ANDA071751METHYLDOPATrueHALSEY DRUG CO INC1988-03-28ANDA071751_001
39ANDA071752METHYLDOPATrueHALSEY DRUG CO INC1988-03-28ANDA071752_001
40ANDA071753METHYLDOPATrueHALSEY DRUG CO INC1988-03-28ANDA071753_001
41ANDA072126METHYLDOPATruePLIVA INC1988-07-07ANDA072126_001
42ANDA072127METHYLDOPATruePLIVA INC1988-07-07ANDA072127_001
43ANDA072128METHYLDOPATruePLIVA INC1988-07-07ANDA072128_001
44NDA013400ALDOMETTrueMERCK RESEARCH LABORATORIES DIV MERCK CO INCNDA013400_001, NDA013400_002, NDA013400_003
45NDA018934METHYLDOPATrueSANDOZ INC1984-06-29NDA018934_001, NDA018934_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA070060_001discontinuedMETHYLDOPA (250MG)ORALTABLETFalse1986-10-09METHYLDOPA
2ANDA070070_003discontinuedMETHYLDOPA (125MG)ORALTABLETFalse1985-10-15METHYLDOPA
3ANDA070073_001discontinuedMETHYLDOPA (125MG)ORALTABLETFalse1986-10-09METHYLDOPA
4ANDA070074_001discontinuedMETHYLDOPA (500MG)ORALTABLETFalse1986-10-09METHYLDOPA
5ANDA070076_001RXMETHYLDOPA (500MG)ORALTABLETTrueAB1985-04-18METHYLDOPA
6ANDA070076_002RXMETHYLDOPA (250MG)ORALTABLETFalseAB1985-04-18METHYLDOPA
7ANDA070084_001RXMETHYLDOPA (250MG)ORALTABLETFalseAB1985-10-15METHYLDOPA
8ANDA070085_001RXMETHYLDOPA (500MG)ORALTABLETFalseAB1985-10-15METHYLDOPA
9ANDA070098_001RXMETHYLDOPA (250MG)ORALTABLETFalseAB1986-02-20METHYLDOPA
10ANDA070192_001discontinuedMETHYLDOPA (125MG)ORALTABLETFalse1986-04-25METHYLDOPA
11ANDA070193_001discontinuedMETHYLDOPA (250MG)ORALTABLETFalse1986-04-25METHYLDOPA
12ANDA070194_001discontinuedMETHYLDOPA (500MG)ORALTABLETFalse1986-04-25METHYLDOPA
13ANDA070245_001discontinuedMETHYLDOPA (125MG)ORALTABLETFalse1986-02-25METHYLDOPA
14ANDA070246_001discontinuedMETHYLDOPA (250MG)ORALTABLETFalse1986-02-25METHYLDOPA
15ANDA070247_001discontinuedMETHYLDOPA (500MG)ORALTABLETFalse1986-02-25METHYLDOPA
16ANDA070260_001discontinuedMETHYLDOPA (125MG)ORALTABLETFalse1985-06-24METHYLDOPA
17ANDA070261_001discontinuedMETHYLDOPA (250MG)ORALTABLETFalse1985-06-24METHYLDOPA
18ANDA070262_001discontinuedMETHYLDOPA (500MG)ORALTABLETFalse1985-06-24METHYLDOPA
19ANDA070331_001discontinuedMETHYLDOPA (125MG)ORALTABLETFalse1986-04-15METHYLDOPA
20ANDA070332_001discontinuedMETHYLDOPA (250MG)ORALTABLETFalse1986-04-15METHYLDOPA
21ANDA070333_001discontinuedMETHYLDOPA (500MG)ORALTABLETFalse1986-04-15METHYLDOPA
22ANDA070343_001RXMETHYLDOPA (500MG)ORALTABLETFalseAB1986-02-20METHYLDOPA
23ANDA070452_001discontinuedMETHYLDOPA (500MG)ORALTABLETFalse1986-02-07METHYLDOPA
24ANDA070535_001discontinuedMETHYLDOPA (125MG)ORALTABLETFalse1987-01-02METHYLDOPA
25ANDA070536_001discontinuedMETHYLDOPA (250MG)ORALTABLETFalse1987-01-02METHYLDOPA
26ANDA070537_001discontinuedMETHYLDOPA (500MG)ORALTABLETFalse1987-01-02METHYLDOPA
27ANDA070625_001RXMETHYLDOPA (500MG)ORALTABLETFalseAB1986-06-06METHYLDOPA
28ANDA070669_001discontinuedMETHYLDOPA (250MG)ORALTABLETFalse1989-06-23METHYLDOPA
29ANDA070670_001discontinuedMETHYLDOPA (500MG)ORALTABLETFalse1989-06-23METHYLDOPA
30ANDA070703_001discontinuedMETHYLDOPA (250MG)ORALTABLETFalse1986-06-06METHYLDOPA
31ANDA070749_001discontinuedMETHYLDOPA (125MG)ORALTABLETFalse1986-02-07METHYLDOPA
32ANDA070750_001discontinuedMETHYLDOPA (250MG)ORALTABLETFalse1986-02-07METHYLDOPA
33ANDA071006_001discontinuedMETHYLDOPA (250MG)ORALTABLETFalse1986-12-16METHYLDOPA
34ANDA071009_001discontinuedMETHYLDOPA (500MG)ORALTABLETFalse1986-12-16METHYLDOPA
35ANDA071067_001discontinuedMETHYLDOPA (500MG)ORALTABLETFalse1986-12-05METHYLDOPA
36ANDA071105_001discontinuedMETHYLDOPA (125MG)ORALTABLETFalse1986-12-05METHYLDOPA
37ANDA071106_001discontinuedMETHYLDOPA (250MG)ORALTABLETFalse1986-12-05METHYLDOPA
38ANDA071700_001discontinuedMETHYLDOPA (125MG)ORALTABLETFalse1988-03-02METHYLDOPA
39ANDA071751_001discontinuedMETHYLDOPA (125MG)ORALTABLETFalse1988-03-28METHYLDOPA
40ANDA071752_001discontinuedMETHYLDOPA (250MG)ORALTABLETFalse1988-03-28METHYLDOPA
41ANDA071753_001discontinuedMETHYLDOPA (500MG)ORALTABLETFalse1988-03-28METHYLDOPA
42ANDA072126_001discontinuedMETHYLDOPA (125MG)ORALTABLETFalse1988-07-07METHYLDOPA
43ANDA072127_001discontinuedMETHYLDOPA (250MG)ORALTABLETFalse1988-07-07METHYLDOPA
44ANDA072128_001discontinuedMETHYLDOPA (500MG)ORALTABLETFalse1988-07-07METHYLDOPA
45NDA013400_001discontinuedMETHYLDOPA (250MG)ORALTABLETFalseALDOMET
46NDA013400_002discontinuedMETHYLDOPA (500MG)ORALTABLETFalseALDOMET
47NDA013400_003discontinuedMETHYLDOPA (125MG)ORALTABLETFalseALDOMET
48NDA018934_001discontinuedMETHYLDOPA (250MG)ORALTABLETFalse1984-06-29METHYLDOPA
49NDA018934_002discontinuedMETHYLDOPA (500MG)ORALTABLETFalse1984-06-29METHYLDOPA

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
100206aae-7db1-4ae9-8500-b03fd6788d74 (view SPL)Methyldopa Tablets, USP Rx onlyprescriptionHuman PrescriptionAccord Healthcare Inc.manufacture2015-04-152167290029, 167290030, 167290031
2227291e5-9baa-476a-93b8-b2142e61a4fe (view SPL)prescriptionHuman PrescriptionMylan Institutional Inc.2015-04-033510790200, 510790201
34eb98b20-561d-453d-8f64-88d1e60faff6 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2012-09-251521250113
460a57abf-9487-4093-9709-40f05755e7b1 (view SPL)METHYLDOPA TABLETS USPRx onlyprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-12-292216950879, 216950880
5916d802c-91b6-4015-9e57-7ebf7e9bb5ee (view SPL)METHYLDOPA TABLETS USPprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2013-06-113000932931, 000932932
6bb1c7c3f-9e6f-4d0e-aea1-6974558659ef (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-05-148003780421, 003780611
7c8bea68b-3932-4538-b568-a296a8817291 (view SPL)METHYLDOPA TABLETS USPRx onlyprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-10-052548680050, 548681328
8cac2489b-7aa8-4d30-b2e4-2937a65fa7cf (view SPL)METHYLDOPA TABLETS USPprescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-06-171545690510
9d87d63fd-48f7-4130-af03-5e263c338fe4 (view SPL)prescriptionHuman PrescriptionCardinal HealthREPACK2013-04-182551545093
10fa1c61c2-7e24-40ff-916e-456b8725a5cd (view SPL)METHYLDOPA TABLETS USPRx onlyprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2012-12-111422540351

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