🇺🇸
United States · US · US:0037-0022_37493a98-a4eb-42d3-8eff-5bf90c4a7f26
sfRowasa
Orange BookUNIISPLATC A07EC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerViatris Specialty LLC
CountryUS (United States)
ATC codeA07EC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1100370022077 BOTTLE, WITH APPLICATOR in 1 CARTON (0037-0022-07) / 60 mL in 1 BOTTLE, WITH APPLICATOR (0037-0022-60)
- ndc11003700222828 BOTTLE, WITH APPLICATOR in 1 CARTON (0037-0022-28) / 60 mL in 1 BOTTLE, WITH APPLICATOR (0037-0022-60)
Annotations
UNII (FDA Substance ID)
4Q81I59GXC
MESALAMINE
RxCUI 52582
Orange Book
N019618
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "4Q81I59GXC",
"rxcui": "52582",
"inchikey": "KBOPZPXVLCULAV-UHFFFAOYSA-N",
"display_name": "MESALAMINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "RECTAL",
"spl_meta": {
"aa273fdc-f7c4-4901-8f71-59ae03b8cdb1": {
"match": "brand_token",
"title": "SFROWASA SULFITE-FREE FORMULATION (MESALAMINE) SUSPENSION [VIATRIS SPECIALTY LLC]",
"spl_version": "12",
"published_date": "2026-03-05"
}
},
"productid": "0037-0022_37493a98-a4eb-42d3-8eff-5bf90c4a7f26",
"productndc": "0037-0022",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "019618",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "4GM/60ML",
"product_no": "001",
"approval_date": "Dec 24, 1987"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "4GM/60ML",
"product_no": "002",
"approval_date": "Jun 20, 2008"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MESALAMINE",
"proprietary_name": "sfRowasa",
"active_ingred_unit": "g/60mL",
"application_number": "NDA019618",
"marketing_category": "NDA",
"nonproprietary_name": "mesalamine",
"start_marketing_date": "20160324",
"active_numerator_strength": "4"
}Related drugs
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