FDA Approves ANDA 077351 for Multiple Oral Acid‑Reducer Brands

The U.S. Food and Drug Administration (FDA) has issued an approval for Abbreviated New Drug Application (ANDA) number 077351. The approval applies to a set of oral dosage products that are marketed under numerous brand names, including ACID RELIEF, ACID REDUCER, HEARTBURN PREVENTION, ACID CONTROLLER, RUGBY FAMOTIDINE, FOSTER AND THRIVE ACID REDUCER, MEMBERS MARK ACID PEP, BASIC CARE ACID REDUCER, CAREONE ACID RELIEF, TOPCARE ACID REDUCER, DG HEALTH ACID REDUCER, EQUALINE HEARTBURN PREVENTION, EQUATE FAMOTIDINE, GOOD SENSE ACID REDUCER, BERKLEY AND JENSEN FAMOTIDINE, ROLAIDS ACID DEFENSE, HEARTBURN RELIEF, DG HEALTH HEARTBURN PREVENTION, SIGNATURE CARE ACID CONTROLLER MAXIMUM STRENGTH, KIRKLAND SIGNATURE ACID CONTROLLER, LEADER ACID REDUCER, BASIC CARE HEARTBURN PREVENTION, MAXIMUM STRENGTH, and MAJOR HEARTBURN RELIEF MAXIMUM STRENGTH. The openFDA data associated with this ANDA lists two National Drug Code (NUI) identifiers (N0000000151, N0000175784), a unique ingredient identifier (UNII 5QZO15J2Z8), the route of administration as ORAL, and a RxNorm Concept Unique Identifier (RXCUI 310273). Multiple SPL (Structured Product Labeling) identifiers are also provided, reflecting the various product labeling files linked to each brand. This approval enables the listed products to be marketed in the United States as generic equivalents, ensuring they meet FDA standards for safety, efficacy, and labeling.