Misoprostol Oral Tablet

Brand(s)
Cytotec
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Greenstone Llc (2014-07-31)
Oldest Current Product
1986-12-27
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\MISOPROSTOL
FDAOB
ORAL\TABLET\MISOPROSTOL
SPL Active
ORAL\TABLET\MISOPROSTOL
SPL Moiety
ORAL\TABLET\MISOPROSTOL

product(s) by strength(s)

misoprostol 0.1 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000251451CytotecNDAG.D. Searle Llc Division Of Pfizer Inc1986-12-27MISOPROSTOLORALTABLETNDA0192684ab12da7-5731-4e06-bf1c-bc3f2e711f12

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1400320160ANDANovel Laboratories, Inc.2012-07-25MISOPROSTOLORALTABLETANDA091667a46d05a2-5014-40ff-8f1b-9eca1b0aff3a
2433860160ANDAGavis Pharmaceuticals, Llc2012-07-25MISOPROSTOLORALTABLETANDA09166714f73ae3-7d8d-4d10-b668-8bd5adf8032c
3597625007NDA AUTHORIZED GENERICGreenstone Llc2009-12-27MISOPROSTOLORALTABLETNDA019268c4fe14fb-0a43-4c31-9cd6-29eb0d156705

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1126340980ANDAApotheca, Inc2010-02-25MISOPROSTOLORALTABLET001734430ANDA076095f15b41bd-ed36-4908-aba5-f0a019b7a26e
2332610754ANDAAidarex Pharmaceuticals Llc2012-07-25MISOPROSTOLORALTABLET433860160ANDA0916674974780a-ca09-4c1e-b593-bfe17ca08480
3529590692NDAH.J. Harkins Company, Inc.2009-12-27MISOPROSTOLORALTABLET597625007NDA019268a5e5413d-bc22-4ae1-959b-0eb0430dbd38
4548682176CytotecNDAPhysicians Total Care, Inc.1996-07-02MISOPROSTOLORALTABLET000251451NDA01926874ae4775-8190-4bab-93d0-0f209023f973
5551543624CytotecNDACardinal Health1988-12-27MISOPROSTOLORALTABLET000251451NDA01926804c42f2b-d049-4892-b003-bdf346cb4ab4
6552890248CytotecNDAPd-Rx Pharmaceuticals, Inc.1986-12-27MISOPROSTOLORALTABLET000251451NDA0192685f6565b7-3d3e-4f5b-bf92-8d9f8002a36a
7552890640NDAPd-Rx Pharmaceuticals, Inc.2009-12-27MISOPROSTOLORALTABLET597625007NDA01926883554310-3991-4a9d-92f1-d71ccfd0fb3a
8680840040ANDAAmerican Health Packaging2013-07-16MISOPROSTOLORALTABLET433860160ANDA091667f902a2a6-0420-4632-a19b-050e40db6803

misoprostol 0.2 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000251461CytotecNDAG.D. Searle Llc Division Of Pfizer Inc1986-12-27MISOPROSTOLORALTABLETNDA0192684ab12da7-5731-4e06-bf1c-bc3f2e711f12

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1400320161ANDANovel Laboratories, Inc.2012-07-25MISOPROSTOLORALTABLETANDA091667a46d05a2-5014-40ff-8f1b-9eca1b0aff3a
2433860161ANDAGavis Pharmaceuticals, Llc2012-07-25MISOPROSTOLORALTABLETANDA09166714f73ae3-7d8d-4d10-b668-8bd5adf8032c
3597625008NDA AUTHORIZED GENERICGreenstone Llc2009-12-27MISOPROSTOLORALTABLETNDA019268c4fe14fb-0a43-4c31-9cd6-29eb0d156705
4637040008ANDAPharmacist Pharmaceutical, Llc2013-04-12MISOPROSTOLORALTABLETANDA09166726aebc95-bd60-4ded-b99c-63f154c5937a

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1126340502NDAApotheca, Inc1997-09-17MISOPROSTOLORALTABLET597625008NDA019268f15b41bd-ed36-4908-aba5-f0a019b7a26e
2126340933CytotecNDAApotheca, Inc2010-01-01MISOPROSTOLORALTABLET000251461NDA01926810644068-fa47-4e3b-9e93-f57ebac3dd17
3332610076ANDAAidarex Pharmaceuticals Llc2012-07-25MISOPROSTOLORALTABLET433860161ANDA0916674974780a-ca09-4c1e-b593-bfe17ca08480
4430630418ANDAPd-Rx Pharmaceuticals, Inc.2012-07-25MISOPROSTOLORALTABLET400320161ANDA091667ec64ed83-0038-4ea1-b733-9428f0c72ed6
5433930203ANDAGenbiopro Inc2013-01-02MISOPROSTOLORALTABLET433860161ANDA0916674179736a-1cb2-4661-8c50-3d68ec7f4025
6545692765CytotecNDAA-S Medication Solutions Llc1986-12-27MISOPROSTOLORALTABLET000251461NDA019268080c268d-4abd-49a3-8b1c-79b19f08995b
7551543613CytotecNDACardinal Health1988-12-27MISOPROSTOLORALTABLET000251461NDA01926804c42f2b-d049-4892-b003-bdf346cb4ab4
8551544998ANDACardinal Health2013-07-16MISOPROSTOLORALTABLET680840041ANDA091667394cd233-a5a5-40ab-9cd1-65db1d1edf86
9581185008NDA AUTHORIZED GENERICClinical Solutions Wholesale2009-12-27MISOPROSTOLORALTABLET597625008NDA0192682c4958e3-4474-470b-89e2-b802c158054f
10636293243ANDABryant Ranch Prepack2002-07-10MISOPROSTOLORALTABLET001724431ANDA076095456e2a53-95bc-4e14-9a17-c4006439cf10
11642050161ANDAReadymeds2012-07-25MISOPROSTOLORALTABLET433860161ANDA091667476053b4-cf15-4f5b-8aad-1019c3b710da
12663360608NDA AUTHORIZED GENERICDispensing Solutions, Inc.2009-12-27MISOPROSTOLORALTABLET597625008NDA0192681f81237e-2cf7-4c85-a054-daffe5bb1c68
13680840041ANDAAmerican Health Packaging2013-07-16MISOPROSTOLORALTABLET433860161ANDA091667f902a2a6-0420-4632-a19b-050e40db6803

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA076095MISOPROSTOLIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA2002-07-10ANDA076095_001, ANDA076095_002
2ANDA091667MISOPROSTOLNOVEL LABORATORIES INC2012-07-25ANDA091667_001, ANDA091667_002
3NDA019268CYTOTECGD SEARLE LLC1988-12-27NDA019268_001, NDA019268_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076095_001RXMISOPROSTOL (0.1MG)ORALTABLETFalseAB2002-07-10MISOPROSTOL
2ANDA076095_002RXMISOPROSTOL (0.2MG)ORALTABLETFalseAB2002-07-10MISOPROSTOL
3ANDA091667_001RXMISOPROSTOL (0.1MG)ORALTABLETFalseAB2012-07-25MISOPROSTOL
4ANDA091667_002RXMISOPROSTOL (0.2MG)ORALTABLETFalseAB2012-07-25MISOPROSTOL
5NDA019268_001RXMISOPROSTOL (0.2MG)ORALTABLETTrueAB1988-12-27CYTOTEC
6NDA019268_003RXMISOPROSTOL (0.1MG)ORALTABLETFalseAB1990-09-21CYTOTEC

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
104c42f2b-d049-4892-b003-bdf346cb4ab4 (view SPL)Cytotec misoprostol tabletsprescriptionHuman PrescriptionCardinal HealthREPACK2014-04-214551543613, 551543624
2080c268d-4abd-49a3-8b1c-79b19f08995b (view SPL)Cytotec misoprostol tabletsprescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-10-261545692765
310644068-fa47-4e3b-9e93-f57ebac3dd17 (view SPL)Cytotec 200 MCG Tablets USP Tradename of Pfizer (misoprostol)prescriptionHuman PrescriptionApotheca, Inc2010-04-011126340933
414f73ae3-7d8d-4d10-b668-8bd5adf8032c (view SPL)Misoprostol Tablets GAVIS Pharmaceuticals, LLCprescriptionHuman PrescriptionGavis Pharmaceuticals, LlcANALYSIS, MANUFACTURE2012-10-232433860160, 433860161
51f81237e-2cf7-4c85-a054-daffe5bb1c68 (view SPL)Misoprostol TabletsprescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2013-07-302663360608
626aebc95-bd60-4ded-b99c-63f154c5937a (view SPL)Misoprostol TabletsprescriptionHuman PrescriptionPharmacist Pharmaceutical, LlcMANUFACTURE2014-11-173637040008
72c4958e3-4474-470b-89e2-b802c158054f (view SPL)Misoprostol TabletsprescriptionHuman PrescriptionClinical Solutions Wholesalerelabel, repack2013-05-231581185008
8394cd233-a5a5-40ab-9cd1-65db1d1edf86 (view SPL)Misoprostol Tablets 8204001/0613 Rx OnlyprescriptionHuman PrescriptionCardinal HealthREPACK2015-02-032551544998
94179736a-1cb2-4661-8c50-3d68ec7f4025 (view SPL)Misoprostol Tablets GenBioPro, Inc.prescriptionHuman PrescriptionGenbiopro Increpack2013-01-021433930203
10456e2a53-95bc-4e14-9a17-c4006439cf10 (view SPL)MISOPROSTOL TABLETSprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-07-281001636293243
11476053b4-cf15-4f5b-8aad-1019c3b710da (view SPL)Misoprostol Tablets GAVIS Pharmaceuticals, LLCprescriptionHuman PrescriptionReadymedsrepack2014-05-063642050161
124974780a-ca09-4c1e-b593-bfe17ca08480 (view SPL)Misoprostol Tablets GAVIS Pharmaceuticals, LLCprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2014-01-151332610076, 332610754
134ab12da7-5731-4e06-bf1c-bc3f2e711f12 (view SPL)Cytotec misoprostol tabletsprescriptionHuman PrescriptionG.D. Searle Llc Division Of Pfizer IncAPI MANUFACTURE, MANUFACTURE, PACK2014-07-317000251451, 000251461
145f6565b7-3d3e-4f5b-bf92-8d9f8002a36a (view SPL)Cytotec misoprostol tabletsprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-03-014552890248
1574ae4775-8190-4bab-93d0-0f209023f973 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-05-101548682176
1683554310-3991-4a9d-92f1-d71ccfd0fb3a (view SPL)Misoprostol TabletsprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2009-10-153552890640
17a46d05a2-5014-40ff-8f1b-9eca1b0aff3a (view SPL)Misoprostol Tablets Novel Laboratories, Inc.prescriptionHuman PrescriptionNovel Laboratories, Inc.ANALYSIS, MANUFACTURE2012-11-053400320160, 400320161
18a5e5413d-bc22-4ae1-959b-0eb0430dbd38 (view SPL)Misoprostol TabletsprescriptionHuman PrescriptionH.J. Harkins Company, Inc.relabel, repack2012-01-192529590692
19c4fe14fb-0a43-4c31-9cd6-29eb0d156705 (view SPL)Misoprostol TabletsprescriptionHuman PrescriptionGreenstone LlcAPI MANUFACTURE, MANUFACTURE, PACK2014-07-317597625007, 597625008
20ec64ed83-0038-4ea1-b733-9428f0c72ed6 (view SPL)Misoprostol Tablets Novel Laboratories, Inc.prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2012-11-053430630418
21f15b41bd-ed36-4908-aba5-f0a019b7a26e (view SPL)MISOPROSTOL 200MCG TABLETS USP Rx OnlyprescriptionHuman PrescriptionApotheca, Inc2010-04-152126340502, 126340980
22f902a2a6-0420-4632-a19b-050e40db6803 (view SPL)Misoprostol Tablets 8204001/0613 Rx OnlyprescriptionHuman PrescriptionAmerican Health PackagingREPACK2013-07-161680840040, 680840041

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