definiens: means the pharmaceutical product with ome prazole and sodiumbicarbonate as the active ingredients, as more particularl y specified under the following NDAs : NDA # 21 - 849 ( capsules ) and NDA # 21 - 636 ( powder for oral susp ension ) . For the purposes ofclarity, shall be limited to drug product for wh ich a prescription from a health carepractitioner is required in order to dispense, purchase or u se such PR Product, and shall exclude anyOTe Product . As of the Effective Date, the PR Product is known as and is marketedsolely in 20 mg and 40 mg powder for oral suspension and capsul e dosage forms . alsoincludes any PR Product Improvements containing omeprazol e as one of the active ingredients to beincluded as PR Products pursuant to Section 4.3