Package 70710-1578-8

Brand: isotretinoin

Generic: isotretinoin
NDC Package

Package Facts

Identity

Package NDC 70710-1578-8
Digits Only 7071015788
Product NDC 70710-1578
Description

3 BLISTER PACK in 1 CARTON (70710-1578-8) / 10 CAPSULE in 1 BLISTER PACK (70710-1578-2)

Marketing

Marketing Status
Marketed Since 2025-06-09
Brand isotretinoin
Generic isotretinoin
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "a5b78223-8bce-490b-a83c-e342c25c082a", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["EH28UP18IF"], "rxcui": ["197843", "197844", "197845", "403930", "1547561", "1547565"], "spl_set_id": ["31f62a49-4c6d-4ce3-a0ca-d159562370b1"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (70710-1578-8)  / 10 CAPSULE in 1 BLISTER PACK (70710-1578-2)", "package_ndc": "70710-1578-8", "marketing_start_date": "20250609"}], "brand_name": "Isotretinoin", "product_id": "70710-1578_a5b78223-8bce-490b-a83c-e342c25c082a", "dosage_form": "CAPSULE", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "70710-1578", "generic_name": "Isotretinoin", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isotretinoin", "active_ingredients": [{"name": "ISOTRETINOIN", "strength": "35 mg/1"}], "application_number": "ANDA216633", "marketing_category": "ANDA", "marketing_start_date": "20250609", "listing_expiration_date": "20261231"}