Package 0713-5401-01

Brand: ambien

Generic: zolpidem tartrate
NDC Package

Package Facts

Identity

Package NDC 0713-5401-01
Digits Only 0713540101
Product NDC 0713-5401
Description

100 TABLET, FILM COATED in 1 BOTTLE (0713-5401-01)

Marketing

Marketing Status
Marketed Since 2025-02-07
Brand ambien
Generic zolpidem tartrate
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "2d934208-e709-2948-e063-6294a90aa9b6", "openfda": {"unii": ["WY6W63843K"], "rxcui": ["854873", "854875", "854876", "854878"], "spl_set_id": ["747949c5-2c91-4909-8a07-71b6826f8e97"], "manufacturer_name": ["Cosette Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (0713-5401-01)", "package_ndc": "0713-5401-01", "marketing_start_date": "20250207"}], "brand_name": "Ambien", "product_id": "0713-5401_2d934208-e709-2948-e063-6294a90aa9b6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Central Nervous System Depression [PE]", "GABA A Receptor Positive Modulators [MoA]", "gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]"], "product_ndc": "0713-5401", "dea_schedule": "CIV", "generic_name": "zolpidem tartrate", "labeler_name": "Cosette Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ambien", "active_ingredients": [{"name": "ZOLPIDEM TARTRATE", "strength": "5 mg/1"}], "application_number": "NDA019908", "marketing_category": "NDA", "marketing_start_date": "20250207", "listing_expiration_date": "20261231"}