NDC 0378-1375

Mesalamine

Mesalamine

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

Product ID0378-1375_c8b93ea3-0367-4605-b87f-06c3812ff3b7
NDC0378-1375
Product TypeHuman Prescription Drug
Proprietary NameMesalamine
Generic NameMesalamine
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2019-11-26
Marketing CategoryANDA / ANDA
Application NumberANDA207271
Labeler NameMylan Pharmaceuticals Inc.
Substance NameMESALAMINE
Active Ingredient Strength0 g/1
Pharm ClassesAminosalicylate [EPC],Aminosalicylic Acids [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-1375-78

120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1375-78)
Marketing Start Date2019-11-26
NDC Exclude FlagN
Sample Package?N

Drug Details

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

NDCBrand NameGeneric Name
43353-884APRISOmesalamine
65649-103APRISOmesalamine
53808-0205Asacolmesalamine
53808-0823ASACOLmesalamine
55154-2305Asacolmesalamine
0023-5901Asacol HDmesalamine
0430-0783ASACOL HDmesalamine
58914-501CanasaMesalamine
65084-474CanasaMesalamine
0023-5853Delzicolmesalamine
50090-3002Delzicolmesalamine
68151-5652Delzicolmesalamine
0179-0142Lialdamesalamine
54092-476Lialdamesalamine
0378-7401Mesalaminemesalamine Film Coated
0378-9230Mesalaminemesalamine
0591-2245MesalamineMesalamine
16714-830mesalaminemesalamine
45802-098MesalamineMesalamine
45802-923MesalamineMesalamine
45802-929MesalamineMesalamine
50090-3497mesalaminemesalamine
54092-100MesalamineMESALAMINE
59762-0118Mesalaminemesalamine
60687-347mesalaminemesalamine
60687-397MesalamineMesalamine
60687-408MesalamineMesalamine
62559-420MesalamineMesalamine
63304-175MesalamineMesalamine
68382-435mesalaminemesalamine
68382-484mesalaminemesalamine
68382-649mesalaminemesalamine
68382-711mesalaminemesalamine
70771-1071mesalaminemesalamine
70771-1110mesalaminemesalamine
0093-5907MesalamineMesalamine
59762-0117MESALAMINEMESALAMINE
64980-282MesalamineMesalamine
42291-563MesalamineMesalamine
42291-564MesalamineMesalamine
0781-7088MesalamineMesalamine
0378-1375Mesalaminemesalamine
68682-113mesalaminemesalamine
69918-560Mesalamine RectalMesalamine
54092-189Pentasamesalamine
54092-191Pentasamesalamine
68151-4769Pentasamesalamine
69189-0189Pentasamesalamine
0037-0066Rowasamesalamine
0037-0022sfRowasamesalamine
70710-1543ZALDYONmesalamine
70771-1353ZALDYONmesalamine

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