Methylergonovine Oral Tablet

Brand(s)
Methergine
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Novel Laboratories, Inc. (2011-05-03)
Oldest Current Product
1946-11-19
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\METHYLERGONOVINE
FDAOB
INJECTION\INJECTION\METHYLERGONOVINE MALEATE\rdfq
ORAL\TABLET\METHYLERGONOVINE MALEATE
SPL Active
ORAL\TABLET, COATED\METHYLERGONOVINE MALEATE
ORAL\TABLET\METHYLERGONOVINE MALEATE
SPL Moiety
ORAL\TABLET, COATED\METHYLERGONOVINE
ORAL\TABLET\METHYLERGONOVINE

product(s) by strength(s)

methylergonovine maleate 0.2 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1400320140ANDANovel Laboratories, Inc.2011-06-15METHYLERGONOVINE MALEATEORALTABLETANDA091577fa75ef56-dcf4-4c3e-bea4-161893e09685
2433860140ANDAGavis Pharmaceuticals, Llc2011-06-15METHYLERGONOVINE MALEATEORALTABLETANDA091577f617b954-71b9-4bef-aeb2-f87eb9f04ef6
3637040006ANDAPharmacist Pharmaceutical, Llc2011-08-01METHYLERGONOVINE MALEATEORALTABLETANDA09157783e4cc2a-a0df-41e4-955d-ee51f29c68cc

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001790122ANDAKaiser Foundations Hospitals2012-05-31METHYLERGONOVINE MALEATEORALTABLET433860140ANDA0915777929b3cf-2902-438a-954f-c5c950e0e402
2126340179MethergineNDAApotheca, Inc2006-12-27METHYLERGONOVINE MALEATEORALTABLET, COATED000780054NDA006035b91d1729-2e8e-4398-9a0d-02763bcfe284
3430630147MethergineNDAPd-Rx Pharmaceuticals, Inc.1946-11-19METHYLERGONOVINE MALEATEORALTABLET, COATED000780054NDA00603594c9b1cf-ae12-45f3-8fcb-708a922cbc10
4430630329ANDAPd-Rx Pharmaceuticals, Inc.2011-08-01METHYLERGONOVINE MALEATEORALTABLET637040006ANDA091577047d3ab6-1f93-4080-95c1-f938ce8d5532
5521250021ANDARemedyrepack Inc.2013-02-25METHYLERGONOVINE MALEATEORALTABLET433860140ANDA0915772233bd51-ca5a-415a-99b6-b294e55d2847
6552890708MethergineNDAPd-Rx Pharmaceuticals, Inc.1946-11-19METHYLERGONOVINE MALEATEORALTABLET, COATED000780054NDA00603553179d26-7dda-4770-a312-37e28f2dc375
7636293791MethergineNDABryant Ranch Prepack1946-11-19METHYLERGONOVINE MALEATEORALTABLET, COATED000780054NDA00603547fd2922-5b1e-4995-8324-ecd495a160e1
8663360402MethergineNDADispensing Solutions, Inc.1946-11-19METHYLERGONOVINE MALEATEORALTABLET, COATED000780054NDA006035b1552d48-86f5-4184-810a-001e57e96c02
9680840554ANDAAmerican Health Packaging2012-05-01METHYLERGONOVINE MALEATEORALTABLET433860140ANDA091577fde7483c-1c37-43f0-b905-c68fcc05a6fd

application(s)

#idtitleapplicantapprovedapproved drugin other drug docs
1ANDA040889METHYLERGONOVINE MALEATEERGOJECT LLC2010-09-13ANDA040889_001Methylergonovine Injectable Solution
2ANDA090193METHYLERGONOVINE MALEATELUITPOLD PHARMACEUTICALS INC2008-11-24ANDA090193_001Methylergonovine Injectable Solution
3ANDA091577METHYLERGONOVINE MALEATENOVEL LABORATORIES INC2011-05-02ANDA091577_001
4NDA006035METHERGINEEDISON THERAPEUTICS LLCNDA006035_003, NDA006035_004Methylergonovine Injectable Solution

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040889_001RXMETHYLERGONOVINE MALEATE (0.2MG/ML)INJECTIONFalseAP2010-09-13METHYLERGONOVINE MALEATE
2ANDA090193_001RXMETHYLERGONOVINE MALEATE (0.2MG/ML)INJECTIONFalseAP2008-11-24METHYLERGONOVINE MALEATE
3ANDA091577_001RXMETHYLERGONOVINE MALEATE (0.2MG)ORALTABLETFalseAB2011-05-02METHYLERGONOVINE MALEATE
4NDA006035_003RXMETHYLERGONOVINE MALEATE (0.2MG)ORALTABLETTrueABMETHERGINE
5NDA006035_004RXMETHYLERGONOVINE MALEATE (0.2MG/ML)INJECTIONTrueAPMETHERGINE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1047d3ab6-1f93-4080-95c1-f938ce8d5532 (view SPL)Methylergonovine Maleate Tablets, USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-05-241430630329
22233bd51-ca5a-415a-99b6-b294e55d2847 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2013-02-252521250021
347fd2922-5b1e-4995-8324-ecd495a160e1 (view SPL)MethergineprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-03-061000636293791
453179d26-7dda-4770-a312-37e28f2dc375 (view SPL)MethergineprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2009-06-187552890708
57929b3cf-2902-438a-954f-c5c950e0e402 (view SPL)METHYLERGONOVINE MALEATE TABLETS, USPprescriptionHuman PrescriptionKaiser Foundations Hospitalsrepack2012-05-311001790122
683e4cc2a-a0df-41e4-955d-ee51f29c68cc (view SPL)Methylergonovine Maleate Tablets, USPprescriptionHuman PrescriptionPharmacist Pharmaceutical, LlcMANUFACTURE2011-05-241637040006
794c9b1cf-ae12-45f3-8fcb-708a922cbc10 (view SPL)MethergineprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2009-06-185430630147
8b1552d48-86f5-4184-810a-001e57e96c02 (view SPL)MethergineprescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2011-09-221663360402
9b91d1729-2e8e-4398-9a0d-02763bcfe284 (view SPL)Methergine (methylergonovine maleate) Tablets, USP Rx onlyprescriptionHuman PrescriptionApotheca, Increlabel, repack2010-02-191126340179
10f617b954-71b9-4bef-aeb2-f87eb9f04ef6 (view SPL)Methylergonovine Maleate Tablets, USPprescriptionHuman PrescriptionGavis Pharmaceuticals, LlcANALYSIS, MANUFACTURE2013-10-182433860140
11fa75ef56-dcf4-4c3e-bea4-161893e09685 (view SPL)Methylergonovine Maleate Tablets, USPprescriptionHuman PrescriptionNovel Laboratories, Inc.API MANUFACTURE, MANUFACTURE2011-05-031400320140
12fde7483c-1c37-43f0-b905-c68fcc05a6fd (view SPL)Methylergonovine Maleate Tablets, USPprescriptionHuman PrescriptionAmerican Health PackagingREPACK2012-07-171680840554

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