Methotrexate Oral Tablet

Brand(s)
Trexall
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Dava Pharmaceuticals, Inc. (2015-07-29)
Oldest Current Product
1953-12-07
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\METHOTREXATE
FDAOB
ORAL\TABLET\METHOTREXATE SODIUM
SPL Active
ORAL\TABLET, FILM COATED\METHOTREXATE SODIUM
ORAL\TABLET\METHOTREXATE
ORAL\TABLET\METHOTREXATE SODIUM
SPL Moiety
ORAL\TABLET, FILM COATED\METHOTREXATE
ORAL\TABLET\METHOTREXATE

product(s) by strength(s)

methotrexate 10 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1512850368TrexallANDATeva Women'S Health, Inc.2001-05-03METHOTREXATE SODIUMORALTABLET, FILM COATEDANDA040385e942f8db-510f-44d6-acb5-b822196f5e8c

methotrexate 15 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1512850369TrexallANDATeva Women'S Health, Inc.2001-05-03METHOTREXATE SODIUMORALTABLET, FILM COATEDANDA040385e942f8db-510f-44d6-acb5-b822196f5e8c

methotrexate 2.5 mg oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1672530320NDADava Pharmaceuticals, Inc.1953-12-07METHOTREXATE SODIUMORALTABLETNDA0080859c4a4784-b063-4c8f-b915-aeb18cb149be
2758400111NDAGenpak Solutions Llc2012-10-01METHOTREXATE SODIUMORALTABLETNDA008085b78cd35a-31ae-4404-9b15-eaffaaba42a0

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000544550ANDARoxane Laboratories, Inc1994-08-01METHOTREXATE SODIUMORALTABLETANDA040054d71b1856-99d8-4a9e-9189-f87b6675f80a
2000548550ANDARoxane Laboratories, Inc1994-08-01METHOTREXATE SODIUMORALTABLETANDA040054d71b1856-99d8-4a9e-9189-f87b6675f80a
3003780014ANDAMylan Pharmaceuticals Inc.1992-05-18METHOTREXATEORALTABLETANDA08123570c09984-2b36-424f-8b27-3fd0cd4e833d
4005550572ANDABarr Laboratories Inc.1990-11-01METHOTREXATE SODIUMORALTABLETANDA0810999b34b1d8-d125-41a2-9f6f-3fab67b573bd

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950111ANDARebel Distributors Corp1990-10-15METHOTREXATE SODIUMORALTABLET005550572ANDA08109968623ad0-a395-4847-88d4-48413c1f4fcf
2422540110NDARebel Distributors Corp1953-12-07METHOTREXATE SODIUMORALTABLET672530320NDA00808503c66d8c-186a-4923-9a32-07ab07d472ad
3422910594ANDAAvkare, Inc.2014-11-20METHOTREXATE SODIUMORALTABLET005550572ANDA081099757d6cef-6696-7a1c-8074-01258aaa8bdd
4430630439ANDAPd-Rx Pharmaceuticals, Inc.1990-11-01METHOTREXATE SODIUMORALTABLET005550572ANDA0810997a64db41-d38e-4228-9f9a-40a9e306ef83
5493490314ANDARemedyrepack Inc.2011-06-20METHOTREXATE SODIUMORALTABLET005550572ANDA081099405d2b6c-b465-41de-ad93-1e009825cd3b
6493490406ANDARemedyrepack Inc.2011-07-21METHOTREXATE SODIUMORALTABLET005550572ANDA0810993614d085-c313-4ce8-8a70-888899b6406e
7510790670ANDAMylan Institutional Inc.1995-07-13METHOTREXATEORALTABLET003780014ANDA0812358df0780e-0fbd-4ab8-80b0-7a5eaa08ec0a
8548683826ANDAPhysicians Total Care, Inc.2007-12-05METHOTREXATE SODIUMORALTABLET005550572ANDA0810994a246ce7-c04e-4119-9201-23e5f90152a8
9552890924NDAPd-Rx Pharmaceuticals, Inc.1953-12-07METHOTREXATE SODIUMORALTABLET672530320NDA00808527dd39ca-207e-44db-8da1-a0689f0d6b6f
10617860417NDARemedyrepack Inc.2015-09-23, 2015-11-12METHOTREXATE SODIUMORALTABLET672530320NDA008085b42be739-2999-496c-bb2e-e2971735173a, e7363e0a-049b-4bf1-8317-606b134f32f7
11636291472ANDABryant Ranch Prepack1994-08-01METHOTREXATE SODIUMORALTABLET000544550ANDA040054271ff7a2-4904-a0ae-778e-0b5ec8e78d76
12663360338NDADispensing Solutions, Inc.1953-12-07METHOTREXATE SODIUMORALTABLET672530320NDA0080857b918398-c33e-44cd-8133-eeb85d36ab9e

methotrexate 5 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1512850366TrexallANDATeva Women'S Health, Inc.2001-05-03METHOTREXATE SODIUMORALTABLET, FILM COATEDANDA040385e942f8db-510f-44d6-acb5-b822196f5e8c

methotrexate 7.5 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1512850367TrexallANDATeva Women'S Health, Inc.2001-05-03METHOTREXATE SODIUMORALTABLET, FILM COATEDANDA040385e942f8db-510f-44d6-acb5-b822196f5e8c

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040054METHOTREXATE SODIUMROXANE LABORATORIES INC1994-08-01ANDA040054_001
2ANDA040233METHOTREXATE SODIUMTrueDURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC1999-06-17ANDA040233_001
3ANDA040385TREXALLBARR LABORATORIES INC2001-03-21ANDA040385_001, ANDA040385_002, ANDA040385_003, ANDA040385_004
4ANDA081099METHOTREXATE SODIUMBARR LABORATORIES INC1990-10-15ANDA081099_001
5ANDA081235METHOTREXATE SODIUMMYLAN PHARMACEUTICALS INC1992-05-15ANDA081235_001
6ANDA201749METHOTREXATE SODIUMORION CORP ORION PHARMA2015-05-21ANDA201749_001
7NDA008085METHOTREXATE SODIUMDAVA PHARMACEUTICALS INCNDA008085_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040054_001RXMETHOTREXATE SODIUM (EQ 2.5MG BASE)ORALTABLETFalseAB1994-08-01METHOTREXATE SODIUM
2ANDA040233_001discontinuedMETHOTREXATE SODIUM (EQ 2.5MG BASE)ORALTABLETFalse1999-06-17METHOTREXATE SODIUM
3ANDA040385_001RXMETHOTREXATE SODIUM (EQ 5MG BASE)ORALTABLETFalse2001-03-21TREXALL
4ANDA040385_002RXMETHOTREXATE SODIUM (EQ 7.5MG BASE)ORALTABLETFalse2001-03-21TREXALL
5ANDA040385_003RXMETHOTREXATE SODIUM (EQ 10MG BASE)ORALTABLETFalse2001-03-21TREXALL
6ANDA040385_004RXMETHOTREXATE SODIUM (EQ 15MG BASE)ORALTABLETTrue2001-03-21TREXALL
7ANDA081099_001RXMETHOTREXATE SODIUM (EQ 2.5MG BASE)ORALTABLETFalseAB1990-10-15METHOTREXATE SODIUM
8ANDA081235_001RXMETHOTREXATE SODIUM (EQ 2.5MG BASE)ORALTABLETFalseAB1992-05-15METHOTREXATE SODIUM
9ANDA201749_001RXMETHOTREXATE SODIUM (EQ 2.5MG BASE)ORALTABLETFalseAB2015-05-21METHOTREXATE SODIUM
10NDA008085_002RXMETHOTREXATE SODIUM (EQ 2.5MG BASE)ORALTABLETTrueABMETHOTREXATE SODIUM

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
103c66d8c-186a-4923-9a32-07ab07d472ad (view SPL)METHOTREXATE TABLETS, USPprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2012-01-101422540110
218705002-da4b-4562-b0d9-df3d56a16c84 (view SPL)METHOTREXATE TABLETS, USPprescriptionHuman PrescriptionMajor2009-12-092009046012
3271ff7a2-4904-a0ae-778e-0b5ec8e78d76 (view SPL)METHOTREXATE Tablets USP, 2.5 mg Rx onlyprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK1994-08-012636291472
427dd39ca-207e-44db-8da1-a0689f0d6b6f (view SPL)METHOTREXATE TABLETS, USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2009-10-231552890924
53614d085-c313-4ce8-8a70-888899b6406e (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-07-211493490406
6405d2b6c-b465-41de-ad93-1e009825cd3b (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-06-201493490314
74a246ce7-c04e-4119-9201-23e5f90152a8 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-06-304548683826
868623ad0-a395-4847-88d4-48413c1f4fcf (view SPL)Methotrexate Tablets, USPprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-12-292216950111
970c09984-2b36-424f-8b27-3fd0cd4e833d (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2013-05-076003780014
10757d6cef-6696-7a1c-8074-01258aaa8bdd (view SPL)METHOTREXATE Tablets 2.5 mg USPprescriptionHuman PrescriptionAvkare, Inc.2014-12-031422910594
117a64db41-d38e-4228-9f9a-40a9e306ef83 (view SPL)METHOTREXATE Tablets 2.5 mg USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2012-08-224430630439
127b918398-c33e-44cd-8133-eeb85d36ab9e (view SPL)METHOTREXATE TABLETS, USPprescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2013-01-142663360338
138df0780e-0fbd-4ab8-80b0-7a5eaa08ec0a (view SPL)prescriptionHuman PrescriptionMylan Institutional Inc.2013-11-015510790670
149b34b1d8-d125-41a2-9f6f-3fab67b573bd (view SPL)METHOTREXATE Tablets 2.5 mg USPprescriptionHuman PrescriptionBarr Laboratories Inc.2013-11-184005550572
159c4a4784-b063-4c8f-b915-aeb18cb149be (view SPL)METHOTREXATE TABLETS, USPprescriptionHuman PrescriptionDava Pharmaceuticals, Inc.2015-07-292672530320
16b42be739-2999-496c-bb2e-e2971735173a (view SPL)METHOTREXATE TABLETS, USPprescriptionHuman PrescriptionRemedyrepack Inc.2015-09-231617860417
17b78cd35a-31ae-4404-9b15-eaffaaba42a0 (view SPL)prescriptionHuman PrescriptionGenpak Solutions Llc2012-07-091758400111
18d71b1856-99d8-4a9e-9189-f87b6675f80a (view SPL)METHOTREXATE Tablets USP, 2.5 mgprescriptionHuman PrescriptionRoxane Laboratories, IncMANUFACTURE2015-09-158000544550, 000548550
19e7363e0a-049b-4bf1-8317-606b134f32f7 (view SPL)METHOTREXATE TABLETS, USPprescriptionHuman PrescriptionRemedyrepack Inc.2015-11-121617860417
20e942f8db-510f-44d6-acb5-b822196f5e8c (view SPL)Trexall (methotrexate tablets USP)prescriptionHuman PrescriptionTeva Women'S Health, Inc.2014-05-163512850366, 512850367, 512850368, 512850369

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