NDC 63304-089

Mesalamine

Mesalamine

Mesalamine is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries Inc.. The primary component is Mesalamine.

Product ID63304-089_8e84aefb-fffe-4fd4-a0ea-e2a1474829da
NDC63304-089
Product TypeHuman Prescription Drug
Proprietary NameMesalamine
Generic NameMesalamine
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2022-05-13
Marketing CategoryANDA /
Application NumberANDA214585
Labeler NameSun Pharmaceutical Industries Inc.
Substance NameMESALAMINE
Active Ingredient Strength500 mg/1
Pharm ClassesAminosalicylate [EPC], Aminosalicylic Acids [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 63304-089-13

120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-089-13)
Marketing Start Date2022-05-13
NDC Exclude FlagN
Sample Package?N

Drug Details

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
0472-1915MesalamineMesalamine
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
0430-0783ASACOL HDmesalamine
0023-5853Delzicolmesalamine
0179-0142Lialdamesalamine
0037-0066Rowasamesalamine
0037-0022sfRowasamesalamine

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