Package 0378-7518-35
Brand: difluprednate
Generic: difluprednatePackage Facts
Identity
Package NDC
0378-7518-35
Digits Only
0378751835
Product NDC
0378-7518
Description
1 BOTTLE in 1 CARTON (0378-7518-35) / 5 mL in 1 BOTTLE
Marketing
Marketing Status
Brand
difluprednate
Generic
difluprednate
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["OPHTHALMIC"], "spl_id": "4a3b2649-ee3d-4648-91c8-912a8ba2e73c", "openfda": {"unii": ["S8A06QG2QE"], "rxcui": ["804544"], "spl_set_id": ["4a3b2649-ee3d-4648-91c8-912a8ba2e73c"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0378-7518-35) / 5 mL in 1 BOTTLE", "package_ndc": "0378-7518-35", "marketing_start_date": "20250926"}], "brand_name": "Difluprednate", "product_id": "0378-7518_4a3b2649-ee3d-4648-91c8-912a8ba2e73c", "dosage_form": "EMULSION", "product_ndc": "0378-7518", "generic_name": "Difluprednate", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Difluprednate", "active_ingredients": [{"name": "DIFLUPREDNATE", "strength": ".5 mg/mL"}], "application_number": "ANDA212566", "marketing_category": "ANDA", "marketing_start_date": "20250926", "listing_expiration_date": "20261231"}