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_881a5ca7-a32d-4473-b789-06211cf9cff7
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 Through2022-12-31

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

NDC SPL Data Element Entries

NDC 0378-1375-78 [00378137578]

Mesalamine CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207271
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-11-26

Drug Details

Active Ingredients

IngredientStrength
MESALAMINE.375 g/1

Pharmacological Class

  • Aminosalicylate [EPC]
  • Aminosalicylic Acids [CS]
  • 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
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