Rowasa

Orange BookUNIISPLATC A07EC02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerViatris Specialty LLC

CountryUS (United States)

ATC codeA07EC02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
0037006603
28 BOTTLE, DISPENSING in 1 CARTON (0037-0066-03) / 60 mL in 1 BOTTLE, DISPENSING (0037-0066-06)
ndc11
0037006605
7 BOTTLE, DISPENSING in 1 CARTON (0037-0066-05) / 60 mL in 1 BOTTLE, DISPENSING (0037-0066-06)

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": {
    "e505ab99-1943-4216-a178-4d5dbe64e3b2": {
      "match": "brand_token",
      "title": "ROWASA (MESALAMINE) SUSPENSION [VIATRIS SPECIALTY LLC]",
      "spl_version": "17",
      "published_date": "2026-05-15"
    }
  },
  "productid": "0037-0066_b6652e84-f693-4388-bd29-21e035ffe4a9",
  "productndc": "0037-0066",
  "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": "Rowasa",
  "active_ingred_unit": "g/60mL",
  "application_number": "NDA019618",
  "marketing_category": "NDA",
  "nonproprietary_name": "mesalamine",
  "start_marketing_date": "20160324",
  "active_numerator_strength": "4"
}

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