NDC 0472-1915

Mesalamine

Mesalamine

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

Product ID0472-1915_0c99f08b-7e50-4351-927f-55d68b803034
NDC0472-1915
Product TypeHuman Prescription Drug
Proprietary NameMesalamine
Generic NameMesalamine
Dosage FormSuppository
Route of AdministrationRECTAL
Marketing Start Date2021-04-23
Marketing CategoryANDA /
Application NumberANDA205654
Labeler NameActavis Pharma, Inc.
Substance NameMESALAMINE
Active Ingredient Strength1000 mg/1
Pharm ClassesAminosalicylate [EPC],Aminosalicylic Acids [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0472-1915-30

30 POUCH in 1 BOX (0472-1915-30) > 1 SUPPOSITORY in 1 POUCH (0472-1915-01)
Marketing Start Date2021-04-23
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
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.