NDC 0591-2245

Mesalamine

Mesalamine

Mesalamine is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Mesalamine.

Product ID0591-2245_38fbd2fa-76de-4f35-92e1-71ce24d4fb94
NDC0591-2245
Product TypeHuman Prescription Drug
Proprietary NameMesalamine
Generic NameMesalamine
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2018-03-26
Marketing CategoryANDA / ANDA
Application NumberANDA203817
Labeler NameActavis Pharma, Inc.
Substance NameMESALAMINE
Active Ingredient Strength1 g/1
Pharm ClassesAminosalicylate [EPC],Aminosalicylic Acids [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0591-2245-22

120 TABLET, DELAYED RELEASE in 1 BOTTLE (0591-2245-22)
Marketing Start Date2018-03-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0591-2245-10 [00591224510]

Mesalamine TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA203817
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-26
Marketing End Date2019-08-29

NDC 0591-2245-22 [00591224522]

Mesalamine TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA203817
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-03-26

Drug Details

Pharmacological Class

  • Aminosalicylate [EPC]
  • Aminosalicylic Acids [CS]

NDC Crossover Matching brand name "Mesalamine" or generic name "Mesalamine"

NDCBrand NameGeneric Name
0093-5907MesalamineMesalamine
0093-9224mesalaminemesalamine
0378-1375Mesalaminemesalamine
0378-7401Mesalaminemesalamine Film Coated
0378-9230Mesalaminemesalamine
68382-711mesalaminemesalamine
68382-484mesalaminemesalamine
68382-435mesalaminemesalamine
68382-649mesalaminemesalamine
0591-2245MesalamineMesalamine
70771-1110mesalaminemesalamine
70771-1071mesalaminemesalamine
16714-830mesalaminemesalamine
45802-923MesalamineMesalamine
45802-929MesalamineMesalamine
45802-098MesalamineMesalamine
50090-3497mesalaminemesalamine
54092-100MesalamineMesalamine
59762-0118MesalamineMesalamine
60687-408MesalamineMesalamine
60687-397MesalamineMesalamine
60687-347mesalaminemesalamine
62559-420MesalamineMesalamine
63304-175MesalamineMesalamine
59762-0117MESALAMINEMESALAMINE
64980-282MesalamineMesalamine
0781-7088MesalamineMesalamine
42291-564MesalamineMesalamine
42291-563MesalamineMesalamine
68682-113mesalaminemesalamine
0023-5901Asacol HDmesalamine
0023-5853Delzicolmesalamine
0179-0142Lialdamesalamine
0037-0066Rowasamesalamine
0037-0022sfRowasamesalamine
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.