Package 55111-113-78

Brand: zenatane

Generic: isotretinoin
NDC Package

Package Facts

Identity

Package NDC 55111-113-78
Digits Only 5511111378
Product NDC 55111-113
Description

10 BLISTER PACK in 1 CARTON (55111-113-78) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (55111-113-79)

Marketing

Marketing Status
Marketed Since 2015-03-09
Brand zenatane
Generic isotretinoin
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "d7d883f9-7d20-2c50-8023-e661b46dcd5b", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["EH28UP18IF"], "rxcui": ["197843", "197844", "197845", "403930", "1373333", "1373335", "1373337", "1605088"], "spl_set_id": ["27b3cf26-f22e-5b70-1c24-009933b7c6ee"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Dr. Reddy's Laboratories Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (55111-113-78)  / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (55111-113-79)", "package_ndc": "55111-113-78", "marketing_start_date": "20150309"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (55111-113-81)  / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (55111-113-79)", "package_ndc": "55111-113-81", "marketing_start_date": "20150309"}], "brand_name": "ZENATANE", "product_id": "55111-113_d7d883f9-7d20-2c50-8023-e661b46dcd5b", "dosage_form": "CAPSULE, GELATIN COATED", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "55111-113", "generic_name": "ISOTRETINOIN", "labeler_name": "Dr. Reddy's Laboratories Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZENATANE", "active_ingredients": [{"name": "ISOTRETINOIN", "strength": "30 mg/1"}], "application_number": "ANDA202099", "marketing_category": "ANDA", "marketing_start_date": "20150309", "listing_expiration_date": "20261231"}