| Product NDC: | 54868-5309 | 
| Proprietary Name: | Prilosec OTC | 
| Non Proprietary Name: | omeprazole magnesium | 
| Active Ingredient(s): | 20.6 mg/1 & nbsp; omeprazole magnesium | 
| Administration Route(s): | ORAL | 
| Dosage Form(s): | TABLET, DELAYED RELEASE | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 54868-5309 | 
| Labeler Name: | Physicians Total Care, Inc. | 
| Product Type: | HUMAN OTC DRUG | 
| FDA Application Number: | NDA021229 | 
| Marketing Category: | NDA | 
| Start Marketing Date: | 20050523 | 
| Package NDC: | 54868-5309-0 | 
| Package Description: | 3 CARTON in 1 CARTON (54868-5309-0) > 1 BLISTER PACK in 1 CARTON > 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK | 
| NDC Code | 54868-5309-0 | 
| Proprietary Name | Prilosec OTC | 
| Package Description | 3 CARTON in 1 CARTON (54868-5309-0) > 1 BLISTER PACK in 1 CARTON > 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK | 
| Product NDC | 54868-5309 | 
| Product Type Name | HUMAN OTC DRUG | 
| Non Proprietary Name | omeprazole magnesium | 
| Dosage Form Name | TABLET, DELAYED RELEASE | 
| Route Name | ORAL | 
| Start Marketing Date | 20050523 | 
| Marketing Category Name | NDA | 
| Labeler Name | Physicians Total Care, Inc. | 
| Substance Name | OMEPRAZOLE MAGNESIUM | 
| Strength Number | 20.6 | 
| Strength Unit | mg/1 | 
| Pharmaceutical Classes |