sfrowasa sulfite-free formulation (0037-0022)

Drug Facts

Product Profile

Brand Name sfrowasa sulfite-free formulation

Generic Name mesalamine

Labeler viatris specialty llc

Dosage Form SUSPENSION

Routes

RECTAL

Active Ingredients

mesalamine 4 g/60mL

Manufacturer

Viatris Specialty LLC

Identifiers & Regulatory

Product NDC 0037-0022

Product ID 0037-0022_37493a98-a4eb-42d3-8eff-5bf90c4a7f26

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category NDA

Application Number NDA019618

Marketing Start 2016-03-24

Marketing End 2026-07-31

Pharmacologic Class

Established (EPC)

aminosalicylate [epc]

Chemical Structure

aminosalicylic acids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00370022

Hyphenated Format 0037-0022

Supplemental Identifiers

RxCUI

206798 238151

UNII

4Q81I59GXC

NUI

N0000175781 M0000971

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sfrowasa sulfite-free formulation (source: ndc)

Generic Name mesalamine (source: ndc)

Application Number NDA019618 (source: ndc)

Routes

RECTAL

source: ndc

Resolved Composition

Strengths

4 g/60mL

source: ndc

Packaging

7 BOTTLE, WITH APPLICATOR in 1 CARTON (0037-0022-07) / 60 mL in 1 BOTTLE, WITH APPLICATOR (0037-0022-60)
28 BOTTLE, WITH APPLICATOR in 1 CARTON (0037-0022-28) / 60 mL in 1 BOTTLE, WITH APPLICATOR (0037-0022-60)

source: ndc

Packages (2)

0037-0022-07 7 BOTTLE, WITH APPLICATOR in 1 CARTON (0037-0022-07) / 60 mL in 1 BOTTLE, WITH APPLICATOR (0037-0022-60) 0037-0022-28 28 BOTTLE, WITH APPLICATOR in 1 CARTON (0037-0022-28) / 60 mL in 1 BOTTLE, WITH APPLICATOR (0037-0022-60)

Ingredients (1)

mesalamine (4 g/60mL)

Linked Drug Pages (1)

sfRowasa Sulfite-Free Formulation ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["RECTAL"], "spl_id": "37493a98-a4eb-42d3-8eff-5bf90c4a7f26", "openfda": {"nui": ["N0000175781", "M0000971"], "unii": ["4Q81I59GXC"], "rxcui": ["206798", "238151"], "spl_set_id": ["aa273fdc-f7c4-4901-8f71-59ae03b8cdb1"], "pharm_class_cs": ["Aminosalicylic Acids [CS]"], "pharm_class_epc": ["Aminosalicylate [EPC]"], "manufacturer_name": ["Viatris Specialty LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "7 BOTTLE, WITH APPLICATOR in 1 CARTON (0037-0022-07)  / 60 mL in 1 BOTTLE, WITH APPLICATOR (0037-0022-60)", "package_ndc": "0037-0022-07", "marketing_end_date": "20260731", "marketing_start_date": "20160324"}, {"sample": false, "description": "28 BOTTLE, WITH APPLICATOR in 1 CARTON (0037-0022-28)  / 60 mL in 1 BOTTLE, WITH APPLICATOR (0037-0022-60)", "package_ndc": "0037-0022-28", "marketing_end_date": "20260731", "marketing_start_date": "20160524"}], "brand_name": "sfRowasa Sulfite-Free Formulation", "product_id": "0037-0022_37493a98-a4eb-42d3-8eff-5bf90c4a7f26", "dosage_form": "SUSPENSION", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "0037-0022", "generic_name": "mesalamine", "labeler_name": "Viatris Specialty LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "sfRowasa", "brand_name_suffix": "Sulfite-Free Formulation", "active_ingredients": [{"name": "MESALAMINE", "strength": "4 g/60mL"}], "application_number": "NDA019618", "marketing_category": "NDA", "marketing_end_date": "20260731", "marketing_start_date": "20160324"}