NDC 0037-0066

Rowasa

Mesalamine

Rowasa is a Rectal Suspension in the Human Prescription Drug category. It is labeled and distributed by Meda Pharmaceuticals. The primary component is Mesalamine.

• Product ID: 0037-0066_25b355a1-136b-42d5-bc09-214387ac6784
• NDC: 0037-0066
• Product Type: Human Prescription Drug
• Proprietary Name: Rowasa
• Generic Name: Mesalamine
• Dosage Form: Suspension
• Route of Administration: RECTAL
• Marketing Start Date: 2016-03-29
• Marketing Category: NDA / NDA
• Application Number: NDA019618
• Labeler Name: Meda Pharmaceuticals
• Substance Name: MESALAMINE
• Active Ingredient Strength: 4 g/60mL
• Pharm Classes: Aminosalicylate [EPC],Aminosalicylic Acids [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0037-0066-03

28 BOTTLE, DISPENSING in 1 CARTON (0037-0066-03) > 60 mL in 1 BOTTLE, DISPENSING (0037-0066-06)

• Marketing Start Date: 2016-03-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0037-0066-05 [00037006605]

Rowasa SUSPENSION

• Marketing Category: NDA
• Application Number: NDA019618
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-03-29

NDC 0037-0066-06 [00037006606]

Rowasa SUSPENSION

• Marketing Category: NDA
• Application Number: NDA019618
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-03-29

NDC 0037-0066-03 [00037006603]

Rowasa SUSPENSION

• Marketing Category: NDA
• Application Number: NDA019618
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-03-29

Drug Details

Active Ingredients

Ingredient	Strength
MESALAMINE	4 g/60mL

OpenFDA Data

• SPL SET ID: e505ab99-1943-4216-a178-4d5dbe64e3b2
• Manufacturer:
  • Meda Pharmaceuticals
• UNII:
  • 4Q81I59GXC
• RxNorm Concept Unique ID - RxCUI:
  • 238151
  • 206798

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0037-0066	Rowasa	mesalamine
0023-5901	Asacol HD	mesalamine
0430-0783	ASACOL HD	mesalamine
0023-5853	Delzicol	mesalamine
0179-0142	Lialda	mesalamine
0093-5907	Mesalamine	Mesalamine
0093-9224	mesalamine	mesalamine
0378-1375	Mesalamine	mesalamine
0378-9230	Mesalamine	mesalamine
0472-1915	Mesalamine	Mesalamine
0037-0022	sfRowasa	mesalamine