Package 0713-5501-01

Brand: ambien cr

Generic: zolpidem tartrate
NDC Package

Package Facts

Identity

Package NDC 0713-5501-01
Digits Only 0713550101
Product NDC 0713-5501
Description

100 TABLET, COATED in 1 BOTTLE (0713-5501-01)

Marketing

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

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "2d9350bd-56ea-7273-e063-6394a90a0e61", "openfda": {"unii": ["WY6W63843K"], "rxcui": ["854880", "854882", "854894", "854896"], "spl_set_id": ["2d934da3-bd77-4470-e063-6294a90a64f5"], "manufacturer_name": ["Cosette Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (0713-5501-01)", "package_ndc": "0713-5501-01", "marketing_start_date": "20250207"}], "brand_name": "Ambien CR", "product_id": "0713-5501_2d9350bd-56ea-7273-e063-6394a90a0e61", "dosage_form": "TABLET, COATED", "pharm_class": ["Central Nervous System Depression [PE]", "GABA A Receptor Positive Modulators [MoA]", "gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]"], "product_ndc": "0713-5501", "dea_schedule": "CIV", "generic_name": "zolpidem tartrate", "labeler_name": "Cosette Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ambien", "brand_name_suffix": "CR", "active_ingredients": [{"name": "ZOLPIDEM TARTRATE", "strength": "6.25 mg/1"}], "application_number": "NDA021774", "marketing_category": "NDA", "marketing_start_date": "20250207", "listing_expiration_date": "20261231"}