Application Nr Approved Date Route Status External Links
NDA021229 2003-06-20 Oral OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Purpose Acid Reducer

All Formulated Excipients (15 Total)

Name Structure Kind Function Status
1. Glyceryl Monostearate GLYCERYL MONOSTEARATE Molecular
2. Hypromelloses HYPROMELLOSES Unresolved
3. Ferric Oxide Red FERRIC OXIDE RED Molecular
4. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
5. Methacrylic Acid Copolymer METHACRYLIC ACID COPOLYMER Unresolved
6. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
7. Paraffin PARAFFIN Unresolved
8. Polyethylene Glycol 6000 POLYETHYLENE GLYCOL 6000 Unresolved
9. Polysorbate 80 POLYSORBATE 80 Unresolved AF-Antifoaming (or defoaming) agent , EMUL-Emulsifier , MISC-Miscellaneous , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
10. Sodium Stearyl Fumarate SODIUM STEARYL FUMARATE Molecular MISC-Miscellaneous , STAB-Stabilizer REG-Food additives for which a petition has been filed and a regulation issued.
11. Starch STARCH Unresolved SANI-Sanitizing agent REG-Food additives for which a petition has been filed and a regulation issued.
12. Sucrose SUCROSE Molecular NUTRS-Nutritive Sweetener GRAS-Generally recognized as safe.
13. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
14. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
15. Triethyl Citrate TRIETHYL CITRATE Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Omeprazole Magnesium OMEPRAZOLE MAGNESIUM ZINC4693575

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