Application Nr Approved Date Route Status External Links
ANDA078878 2009-06-05 Oral OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Purpose Acid Reducer

All Formulated Excipients (18 Total)

Name Structure Kind Function Status
1. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
2. Calcium Phosphate, Dibasic, Anhydrous CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS Molecular
3. Gelatin GELATIN Unresolved
4. Glyceryl Monostearate GLYCERYL MONOSTEARATE Molecular
5. Magnesium Oxide MAGNESIUM OXIDE Molecular DS-Dietary supplement , MISC-Miscellaneous , NUTR-Nutrient GRAS-Generally recognized as safe.
6. 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.
7. Methacrylic Acid - Methyl Methacrylate Copolymer (1:2) METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2) Unresolved
8. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE 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. Potassium Hydroxide POTASSIUM HYDROXIDE Molecular B&N-Buffer & neutralizing agent , MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
11. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
12. Ferric Oxide Red FERRIC OXIDE RED Molecular
13. Shellac SHELLAC Unresolved
14. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
15. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
16. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
17. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
18. 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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