Norethindrone Oral Tablet

Brand(s)
Aygestin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Amneal Pharmaceuticals (2015-10-01)
Oldest Current Product
2001-06-29
License(s)
ANDA
RxNORM
ORAL TABLET\NORETHINDRONE
FDAOB
ORAL-28\TABLET\NORETHINDRONE\rdfq
ORAL\TABLET\NORETHINDRONE ACETATE
SPL Active
ORAL\TABLET\NORETHINDRONE
ORAL\TABLET\NORETHINDRONE ACETATE
SPL Moiety
ORAL\TABLET\NORETHINDRONE

product(s) by strength(s)

norethindrone 0.35 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1167140073ANDANorthstar Rx Llc2013-09-07NORETHINDRONEORALTABLETANDA200961fba59f9c-4fe0-4d90-9966-cf9e6f29cfe0
2167140413ANDANorthstar Rx Llc2013-09-10NORETHINDRONEORALTABLETANDA202014ac4ab968-c536-45d8-bb85-dc692afd7cee

norethindrone acetate 5 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005550211ANDABarr Laboratories Inc.2001-06-29NORETHINDRONE ACETATEORALTABLETANDA075951f73f9807-4af6-4faa-ba9a-656a47a4c5e0
2512850424AygestinANDATeva Women'S Health, Inc.2003-06-12NORETHINDRONE ACETATEORALTABLETANDA07595169f5bc4b-758d-471b-ad8d-17c94f8e0963
3651620475ANDAAmneal Pharmaceuticals2009-07-01NORETHINDRONE ACETATEORALTABLETANDA20027564cb920c-36e8-4d62-9d08-3ddf3989d313
4684620304ANDAGlenmark Generics Inc., Usa2010-07-21NORETHINDRONE ACETATEORALTABLETANDA091090d0a94321-eb60-4aa6-a429-f0156f9f8e01

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001791847ANDAKaiser Foundations Hospitals2015-02-19NORETHINDRONE ACETATEORALTABLET005550211ANDA0759514ecd9d66-9ae3-4d82-bf2d-f83c10cc5501
2422910650ANDAAvkare, Inc.2013-06-18NORETHINDRONE ACETATEORALTABLET651620475ANDA200275827c7ef1-a8b7-d0c4-b062-c5154b331a35
3502680602ANDAAvpak2014-11-17NORETHINDRONE ACETATEORALTABLET651620475ANDA200275ccef4732-5307-7d4b-aa56-04aa6f2af5f9

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA075951NORETHINDRONE ACETATEBARR LABORATORIES INC2001-05-25ANDA075951_001
2ANDA076177CAMILABARR LABORATORIES INC2002-10-21ANDA076177_001
3ANDA076225ERRINBARR LABORATORIES INC2002-10-21ANDA076225_001
4ANDA090454HEATHERGLENMARK GENERICS LTD2010-04-23ANDA090454_001
5ANDA091090NORETHINDRONE ACETATEGLENMARK GENERICS LTD INDIA2010-07-21ANDA091090_001
6ANDA091209NORETHINDRONEGLENMARK GENERICS LTD2010-07-21ANDA091209_001
7ANDA091323JENCYCLALUPIN LTD2013-03-28ANDA091323_001
8ANDA091325NORETHINDRONELUPIN LTD2011-09-19ANDA091325_001
9ANDA200275NORETHINDRONE ACETATEAMNEAL PHARMACEUTICALS2012-07-30ANDA200275_001
10ANDA200961NORETHINDRONENOVAST LABORATORIES CHINA LTD2013-09-13ANDA200961_001
11ANDA200980NORETHINDRONEJAI PHARMA LTD2013-06-12ANDA200980_001
12ANDA201483NORETHINDRONEJAI PHARMA LTD2013-06-24ANDA201483_001
13ANDA202014NORETHINDRONENOVAST LABORATORIES LTD2013-09-13ANDA202014_001
14ANDA202260NORETHINDRONEHAUPT PHARMA INC2013-08-01ANDA202260_001
15NDA012184NORLUTATETruePARKE DAVIS DIV WARNER LAMBERT CONDA012184_002
16NDA016954MICRONORJANSSEN PHARMACEUTICALS INCNDA016954_001
17NDA017060NOR-QDACTAVIS LABORATORIES UT INCNDA017060_001
18NDA018405AYGESTINDURAMED RESEARCH INC1982-04-21NDA018405_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA075951_001RXNORETHINDRONE ACETATE (5MG)ORALTABLETFalseAB2001-05-25NORETHINDRONE ACETATE
2ANDA076177_001RXNORETHINDRONE (0.35MG)TABLETFalseAB12002-10-21CAMILA
3ANDA076225_001RXNORETHINDRONE (0.35MG)TABLETFalseAB22002-10-21ERRIN
4ANDA090454_001RXNORETHINDRONE (0.35MG)TABLETFalseAB12010-04-23HEATHER
5ANDA091090_001RXNORETHINDRONE ACETATE (5MG)ORALTABLETFalseAB2010-07-21NORETHINDRONE ACETATE
6ANDA091209_001RXNORETHINDRONE (0.35MG)TABLETFalseAB22010-07-21NORETHINDRONE
7ANDA091323_001RXNORETHINDRONE (0.35MG)TABLETFalseAB22013-03-28JENCYCLA
8ANDA091325_001RXNORETHINDRONE (0.35MG)TABLETFalseAB12011-09-19NORETHINDRONE
9ANDA200275_001RXNORETHINDRONE ACETATE (5MG)ORALTABLETFalseAB2012-07-30NORETHINDRONE ACETATE
10ANDA200961_001RXNORETHINDRONE (0.35MG)TABLETFalseAB22013-09-13NORETHINDRONE
11ANDA200980_001RXNORETHINDRONE (0.35MG)TABLETFalseAB22013-06-12NORETHINDRONE
12ANDA201483_001RXNORETHINDRONE (0.35MG)TABLETFalseAB12013-06-24NORETHINDRONE
13ANDA202014_001RXNORETHINDRONE (0.35MG)TABLETFalseAB12013-09-13NORETHINDRONE
14ANDA202260_001RXNORETHINDRONE (0.35MG)TABLETFalseAB12013-08-01NORETHINDRONE
15NDA012184_002discontinuedNORETHINDRONE ACETATE (5MG)ORALTABLETFalseNORLUTATE
16NDA016954_001RXNORETHINDRONE (0.35MG)TABLETTrueAB2MICRONOR
17NDA017060_001RXNORETHINDRONE (0.35MG)TABLETTrueAB1NOR-QD
18NDA018405_001RXNORETHINDRONE ACETATE (5MG)ORALTABLETTrueAB1982-04-21AYGESTIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
14ecd9d66-9ae3-4d82-bf2d-f83c10cc5501 (view SPL)NORETHINDRONE ACETATE TABLETS USPprescriptionHuman PrescriptionKaiser Foundations Hospitalsrepack2015-02-241001791847
264cb920c-36e8-4d62-9d08-3ddf3989d313 (view SPL)Norethindrone Acetate Tablets, USPprescriptionHuman PrescriptionAmneal PharmaceuticalsANALYSIS, LABEL, MANUFACTURE, PACK2015-10-0112651620475
369f5bc4b-758d-471b-ad8d-17c94f8e0963 (view SPL)AYGESTIN (norethindrone acetate tablets, USP)prescriptionHuman PrescriptionTeva Women'S Health, Inc.2012-08-105512850424
4827c7ef1-a8b7-d0c4-b062-c5154b331a35 (view SPL)Norethindrone Acetate Tablets, USPprescriptionHuman PrescriptionAvkare, Inc.2013-06-181422910650
5ac4ab968-c536-45d8-bb85-dc692afd7cee (view SPL)Norethindrone Tablets USP, 0.35 mgprescriptionHuman PrescriptionNorthstar Rx LlcMANUFACTURE2013-09-102167140413
6ccef4732-5307-7d4b-aa56-04aa6f2af5f9 (view SPL)Norethindrone Acetate Tablets, USPprescriptionHuman PrescriptionAvpak2014-11-171502680602
7d0a94321-eb60-4aa6-a429-f0156f9f8e01 (view SPL)Norethindrone Acetate Tablets USP, 5 mgprescriptionHuman PrescriptionGlenmark Generics Inc., UsaANALYSIS, MANUFACTURE2013-09-234684620304
8f73f9807-4af6-4faa-ba9a-656a47a4c5e0 (view SPL)NORETHINDRONE ACETATE TABLETS USPprescriptionHuman PrescriptionBarr Laboratories Inc.2012-08-173005550211
9fba59f9c-4fe0-4d90-9966-cf9e6f29cfe0 (view SPL)Norethindrone Tablets, USP, 0.35 mgprescriptionHuman PrescriptionNorthstar Rx LlcMANUFACTURE2013-09-071167140073

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