Package 68791-101-01

Brand: derma-smoothe/fs

Generic: fluocinolone acetonide
NDC Package Sample

Package Facts

Identity

Package NDC 68791-101-01
Digits Only 6879110101
Product NDC 68791-101
Description

1 BOTTLE in 1 CARTON (68791-101-01) / 20 mL in 1 BOTTLE

Marketing

Marketing Status
Marketed Since 2024-05-06
Brand derma-smoothe/fs
Generic fluocinolone acetonide
Sample Package Yes

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["TOPICAL"], "spl_id": "a1decdf5-a06c-40b9-a2b4-d27006b8f01c", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["0CD5FD6S2M"], "rxcui": ["1191307", "1191309"], "spl_set_id": ["bc61c619-a71c-46f5-80f1-9e9ee71134aa"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Royal Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 BOTTLE in 1 CARTON (68791-101-01)  / 20 mL in 1 BOTTLE", "package_ndc": "68791-101-01", "marketing_start_date": "20240506"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (68791-101-04)  / 118.28 mL in 1 BOTTLE", "package_ndc": "68791-101-04", "marketing_start_date": "19950216"}], "brand_name": "Derma-Smoothe/FS", "product_id": "68791-101_a1decdf5-a06c-40b9-a2b4-d27006b8f01c", "dosage_form": "OIL", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "68791-101", "generic_name": "fluocinolone acetonide", "labeler_name": "Royal Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Derma-Smoothe/FS", "active_ingredients": [{"name": "FLUOCINOLONE ACETONIDE", "strength": ".11 mg/mL"}], "application_number": "NDA019452", "marketing_category": "NDA", "marketing_start_date": "19950216", "listing_expiration_date": "20261231"}