Details of the Drug Formulations

General Information of Drug (ID: DMOL5IU)

Drug Name

Mesalazine Drug Info

Synonyms

Apriso; Asacol; Asacolitin; Asacolon; Asalit; Ascolitin; Canasa; Claversal; Fisalamine; Fivasa; Iialda; Ipocol; Lialda; Lixacol; Mesacol; Mesalamine; Mesalazina; Mesalazinum; Mesasal; Mesavance; Mesavancol; Mezavant; Pentacol; Pentasa; Rowasa; Salofalk; Salozinal; SfRowasa; Allphar Brand of Mesalamine; Antigen Brand of Mesalamine; Asacol HD; Axcan Brand of Mesalamine; Byk Brand of Mesalamine; Celltech Brand of Mesalamine; Falk Brand of Mesalamine; Farmasa Brand of Mesalamine; Ferring Brand of Mesalamine; GlaxoSmithKline Brand of Mesalamine; Henning Berlin Brand of Mesalamine; M Aminosalicylic Acid; Merckle Brand of Mesalamine; Mesalamine Hydrochloride; Mesalamine Monosodium Salt; Mesalamine [USAN]; Mesalazina[Spanish]; Mesalazine MMX; Mesalazinum [Latin]; Meta Aminosalicylic Acid; Mezavant XL; Minosalicylic acid; Norgine Brand of Mesalamine; Novopharm Brand of Mesalamine; Provalis Brand of Mesalamine; Sanofi Synthelabo Brand of Mesalamine; Schering Plough Brand of Mesalamine; SmithKline Brand of Mesalamine; Solvay Brand of Mesalamine; Yamanouchi Brand of Mesalamine; Novo 5 ASA; Novo5 ASA; AJG-501; Apriso (TN); Asacol (TN); Canasa (TN); Hydrochloride, Mesalamine; Iialda (TN); Ipocal (TN); Lialda (TN); M-A; M-Aminosalicylic acid; MAX-002; MD-0901; Masacol (TN); Mesalamine (USP); Meta-AminosalicylicAcid; Monosodium Salt, Mesalamine; Novo-5 ASA; P-Aminosalicylsaeure; P-Aminosalicylsaeure [German]; Pentasa (TN); Procter & Gamble Brand of Mesalamine; Rowasa (TN); SPD-476; SPD-480; Salofalk (TN); Salofalk Granu-Stix; Schering-Plough Brand of Mesalamine; Z-206; Mesalazine (JAN/INN); Salicylic acid, 5-amino-(8CI); 2-Hydroxy-5-aminobenzoic acid; 3-carboxy-4-hydroxyaniline; 5 Aminosalicylate; 5 Aminosalicylic Acid; 5-AS; 5-ASA; 5-Amino-2-hydroxybenzoic acid; 5-Aminosalicylate; 5-Aminosalicylic acid; 5-amino-2-hydroxy-benzoic acid; 5-aminosalicylic acid, Mesalazine, Asacol, Pentasa, Canasa, Mesalamine

Indication

Disease Entry	ICD 11	Status	REF
Diverticulitis		Approved	[1]
Proctitis	DB33.Z	Approved	[2]
Ulcerative colitis	DD71	Approved	[3]
Ulcerative proctosigmoiditis		Approved	[4]

Therapeutic Class

Antiinflammatory Agents

Cross-matching ID

PubChem CID: 4075
ChEBI ID: CHEBI:6775
CAS Number: 89-57-6
TTD ID: D0C4YC
VARIDT ID: DR00856
INTEDE ID: DR1032
ACDINA ID: D00401

Full List of Drug Formulations Containing This Drug

Mesalamine 1200 mg tablet

Company	Formulation ID	FDA Description
Kaiser Foundation Hospitals	F13046	Stearic acid; Magnesium stearate; Ferric oxide red; Talc; Titanium dioxide; Triethyl citrate; Carboxymethylcellulose sodium; Polyethylene glycol 6000; Silicon dioxide; Carnauba wax; Methacrylic acid - methyl methacrylate copolymer (1:1); Methacrylic acid - methyl methacrylate copolymer (1:2); Sodium starch glycolate type a potato
Avera McKennan Hospital; Shire	F13048	Stearic acid; Magnesium stearate; Ferric oxide red; Talc; Titanium dioxide; Triethyl citrate; Polyethylene glycol 6000; Silicon dioxide; Carboxymethylcellulose sodium, unspecified form; Carnauba wax; Methacrylic acid - methyl methacrylate copolymer (1:1); Methacrylic acid - methyl methacrylate copolymer (1:2); Sodium starch glycolate type a potato
Cadila Healthcare; Zydus Pharmaceuticals	F13047	Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Talc; Titanium dioxide; Triethyl citrate; Carboxymethylcellulose sodium; Silicon dioxide; Cellulose, microcrystalline; Hypromelloses; Methacrylic acid; Polyethylene glycol, unspecified; Sodium starch glycolate type a potato
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Mesalamine 375 mg capsule

Company	Formulation ID	FDA Description
Physicians Total Care	F13051	Anhydrous citric acid; Aspartame; Magnesium stearate; Talc; Titanium dioxide; Triethyl citrate; Povidone; Silicon dioxide; Cellulose, microcrystalline; Hypromelloses; Methacrylic acid - methyl methacrylate copolymer (1:1)
Aphena Pharma Solutions-Tennessee; Salix Pharmaceuticals	F13052	Anhydrous citric acid; Aspartame; Magnesium stearate; Talc; Titanium dioxide; Triethyl citrate; Silicon dioxide; Crospovidone, unspecified; Hypromellose, unspecified; Methacrylic acid - methyl methacrylate copolymer (1:1); Microcrystalline cellulose
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Mesalamine 400 mg tablet

Company	Formulation ID	FDA Description
RemedyRepack	F13055	Lactose monohydrate; Dibutyl phthalate; Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Talc; Povidone; Silicon dioxide; Methacrylic acid - methyl methacrylate copolymer (1:2); Polyethylene glycols; Sodium starch glycolate type a potato
Kaiser Foundation Hospitals; Lake Eire Medical & Surgical Supply DBA Quality Care Products; RemedyRepack	F13056	Lactose monohydrate; Dibutyl phthalate; Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Talc; Povidone; Silicon dioxide; Methacrylic acid - methyl methacrylate copolymer (1:2); Polyethylene glycol; Sodium starch glycolate type a potato
State of Florida DOH Central Pharmacy	F13057	Lactose monohydrate; Dibutyl phthalate; Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Talc; Povidone; Silicon dioxide; Methacrylic acid - methyl methacrylate copolymer (1:2); Polyethylene glycols; Sodium starch glycolate type a potato
Allergan	F13059	Lactose monohydrate; Dibutyl phthalate; Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Talc; Povidone; Silicon dioxide; Methacrylic acid; Poly(methyl methacrylate 450000 mw); Polyethylene glycols; Sodium starch glycolate type a potato
Cardinal Health	F13058	Lactose monohydrate; Dibutyl phthalate; Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Talc; Silicon dioxide; Methacrylic acid - methyl methacrylate copolymer (1:2); Polyethylene glycols; Povidones; Sodium starch glycolate type a potato
State of Florida DOH Central Pharmacy	F13061	Lactose monohydrate; Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Talc; Povidone; Methacrylic acid - methyl methacrylate copolymer (1:2); Polyethylene glycol; Sodium starch glycolate type a potato
Cardinal Health	F13060	Lactose monohydrate; Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Talc; Methacrylic acid - methyl methacrylate copolymer (1:2); Polyethylene glycol, unspecified; Povidone, unspecified; Sodium starch glycolate type a potato
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⏷ Show the Full List of 7 Formulation(s)

Mesalamine 800 mg tablet

Company	Formulation ID	FDA Description
Zydus Pharmaceuticals	F13065	Lactose monohydrate; Dibutyl phthalate; Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Talc; Povidone; Silicon dioxide; Methacrylic acid - ethyl acrylate copolymer (1:1) type a; Methacrylic acid - methyl methacrylate copolymer (1:2); Polyethylene glycols; Sodium starch glycolate type a potato
American Health Packaging	F13066	Lactose monohydrate; Dibutyl phthalate; Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Talc; Silicon dioxide; Methacrylic acid - ethyl acrylate copolymer (1:1) type a; Methacrylic acid - methyl methacrylate copolymer (1:2); Polyethylene glycols; Povidones; Sodium starch glycolate type a potato
Zydus Pharmaceuticals	F13067	Lactose monohydrate; Dibutyl sebacate; Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Talc; Povidone; Silicon dioxide; Methacrylic acid - methyl methacrylate copolymer (1:1); Methacrylic acid - methyl methacrylate copolymer (1:2); Polyethylene glycols; Sodium starch glycolate type a potato
Allergan	F13069	Lactose monohydrate; Dibutyl sebacate; Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Talc; Povidone; Silicon dioxide; Methacrylic acid - ethyl acrylate copolymer (1:1) type a; Methacrylic acid - methyl methacrylate copolymer (1:2); Polyethylene glycols; Sodium starch glycolate type a potato
Allergan	F13068	Lactose monohydrate; Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Talc; Povidone; Methacrylic acid - ethyl acrylate copolymer (1:1) type a; Methacrylic acid - methyl methacrylate copolymer (1:2); Polyethylene glycols; Sodium starch glycolate type a potato
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Mesalamine 250 mg capsule

Company	Formulation ID	FDA Description
Avera McKennan Hospital; Cardinal Health; Carilion Materials Management; Prasco	F13049	Stearic acid; D&c yellow no. 10; Fd&c blue no. 1; Talc; Titanium dioxide; Silicon dioxide; Castor oil; Fd&c green no. 3; Gelatin
Shire	F13050	Stearic acid; D&c yellow no. 10; Fd&c blue no. 1; Talc; Titanium dioxide; Silicon dioxide; Castor oil; Fd&c green no. 3; Gelatin, unspecified
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Mesalamine 500 mg capsule

Company	Formulation ID	FDA Description
Prasco; RemedyRepack	F13063	Stearic acid; Fd&c blue no. 1; Talc; Titanium dioxide; Silicon dioxide; Castor oil; Gelatin
Shire	F13064	Stearic acid; Fd&c blue no. 1; Talc; Titanium dioxide; Silicon dioxide; Castor oil; Gelatin, unspecified
RemedyRepack	F13062	Stearic acid; Fd&c blue no. 1; Talc; Titanium dioxide; Castor oil; Colloidal silicon dioxide; Gelatin
Physicians Total Care	F13070	Stearic acid; Fd&c blue no. 1; Talc; Titanium dioxide; Castor oil; Colloidal silicon dioxide; Gelatin
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Mesalamine 400 mg capsule

Company	Formulation ID	FDA Description
Allergan	F13053	Lactose monohydrate; Dibutyl sebacate; Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Talc; Povidone; Silicon dioxide; Hypromelloses; Methacrylic acid - methyl methacrylate copolymer (1:2); Polyethylene glycols; Sodium starch glycolate type a potato
Carilion Materials Management	F13054	Lactose monohydrate; Dibutyl sebacate; Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Talc; Silicon dioxide; Hypromelloses; Methacrylic acid - methyl methacrylate copolymer (1:2); Polyethylene glycols; Povidones; Sodium starch glycolate type a potato
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References

1	Colonic diverticular disease. Nat Rev Dis Primers. 2020 Mar 26;6(1):20.
2	Optimized Management of Ulcerative Proctitis: When and How to Use Mesalazine Suppository. Digestion. 2018;97(1):59-63.
3	URL: http://www.guidetopharmacology.org Nucleic Acids Res. 2015 Oct 12. pii: gkv1037. The IUPHAR/BPS Guide to PHARMACOLOGY in 2016: towards curated quantitative interactions between 1300 protein targets and 6000 ligands. (Ligand id: 4655).
4	Efficacy of Oral, Topical, or Combined Oral and Topical 5-Aminosalicylates, in Ulcerative Colitis: Systematic Review and Network Meta-analysis. J Crohns Colitis. 2021 Jul 5;15(7):1184-1196.