NDC 70771-1513

Mesalamine

Mesalamine

Mesalamine is a Rectal Suppository in the Human Prescription Drug category. It is labeled and distributed by Zydus Lifesciences Limited. The primary component is Mesalamine.

Product ID70771-1513_2d9461f3-adf4-4c79-9cec-f4c224b24928
NDC70771-1513
Product TypeHuman Prescription Drug
Proprietary NameMesalamine
Generic NameMesalamine
Dosage FormSuppository
Route of AdministrationRECTAL
Marketing Start Date2020-02-14
Marketing CategoryANDA / ANDA
Application NumberANDA208953
Labeler NameZydus Lifesciences Limited
Substance NameMESALAMINE
Active Ingredient Strength1000 mg/1
Pharm ClassesAminosalicylate [EPC], Aminosalicylic Acids [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 70771-1513-7

5 BLISTER PACK in 1 POUCH (70771-1513-7) > 6 SUPPOSITORY in 1 BLISTER PACK (70771-1513-6)
Marketing Start Date2020-02-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70771-1513-6 [70771151306]

Mesalamine SUPPOSITORY
Marketing CategoryANDA
Application NumberANDA208953
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-14

NDC 70771-1513-7 [70771151307]

Mesalamine SUPPOSITORY
Marketing CategoryANDA
Application NumberANDA208953
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-14

Drug Details

Active Ingredients

IngredientStrength
MESALAMINE1000 mg/1

Pharmacological Class

  • 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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