NDC 64980-282

Mesalamine

Mesalamine

Mesalamine is a Rectal Suppository in the Human Prescription Drug category. It is labeled and distributed by Rising Pharmaceuticals, Inc.. The primary component is Mesalamine.

Product ID64980-282_de981df1-747a-480d-a866-e72332a1544d
NDC64980-282
Product TypeHuman Prescription Drug
Proprietary NameMesalamine
Generic NameMesalamine
Dosage FormSuppository
Route of AdministrationRECTAL
Marketing Start Date2019-06-05
Marketing CategoryANDA / ANDA
Application NumberANDA207448
Labeler NameRising Pharmaceuticals, Inc.
Substance NameMESALAMINE
Active Ingredient Strength1000 mg/1
Pharm ClassesAminosalicylate [EPC],Aminosalicylic Acids [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 64980-282-03

5 PACKAGE in 1 CARTON (64980-282-03) > 6 SUPPOSITORY in 1 PACKAGE
Marketing Start Date2019-06-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64980-282-03 [64980028203]

Mesalamine SUPPOSITORY
Marketing CategoryANDA
Application NumberANDA207448
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-06-05

Drug Details

Active Ingredients

IngredientStrength
MESALAMINE1000 mg/1

OpenFDA Data

SPL SET ID:de981df1-747a-480d-a866-e72332a1544d
Manufacturer
UNII

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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