Package 64380-440-02

Brand: hydrocodone bitartrate and acetaminophen

Generic: hydrocodone bitartrate and acetaminophen
NDC Package

Package Facts

Identity

Package NDC 64380-440-02
Digits Only 6438044002
Product NDC 64380-440
Description

500 TABLET in 1 BOTTLE (64380-440-02)

Marketing

Marketing Status
Marketed Since 2025-09-01
Brand hydrocodone bitartrate and acetaminophen
Generic hydrocodone bitartrate and acetaminophen
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "79fdcad6-7c73-47ae-8371-55b76084eb62", "openfda": {"upc": ["0364380440017", "0364380441014", "0364380442011"], "unii": ["362O9ITL9D", "NO70W886KK"], "rxcui": ["856999", "857002", "857005"], "spl_set_id": ["cc7f0a16-ff27-44d0-b69a-3f6aea1b993b"], "manufacturer_name": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (64380-440-01)", "package_ndc": "64380-440-01", "marketing_start_date": "20250901"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (64380-440-02)", "package_ndc": "64380-440-02", "marketing_start_date": "20250901"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (64380-440-03)", "package_ndc": "64380-440-03", "marketing_start_date": "20250901"}], "brand_name": "hydrocodone bitartrate and acetaminophen", "product_id": "64380-440_79fdcad6-7c73-47ae-8371-55b76084eb62", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "64380-440", "dea_schedule": "CII", "generic_name": "hydrocodone bitartrate and acetaminophen", "labeler_name": "Strides Pharma Science Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "hydrocodone bitartrate and acetaminophen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "HYDROCODONE BITARTRATE", "strength": "5 mg/1"}], "application_number": "ANDA202935", "marketing_category": "ANDA", "marketing_start_date": "20250901", "listing_expiration_date": "20271231"}