Package 0116-4023-16

Brand: promethazine hydrochloride

Generic: promethazine hydrochloride
NDC Package

Package Facts

Identity

Package NDC 0116-4023-16
Digits Only 0116402316
Product NDC 0116-4023
Product ID 0116-4023_302bfe23-7984-140e-e063-6394a90acad1
Description

473 mL in 1 BOTTLE, PLASTIC (0116-4023-16)

Marketing

Marketing Status
Marketed Since 2025-04-07
Brand promethazine hydrochloride
Generic promethazine hydrochloride
Sample Package No

Linked Drug Pages (1)

PROMETHAZINE HYDROCHLORIDE ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "302bfe23-7984-140e-e063-6394a90acad1", "openfda": {"upc": ["0301164023165"], "unii": ["R61ZEH7I1I"], "rxcui": ["992432"], "spl_set_id": ["302bfea2-d403-d315-e063-6294a90a37dd"], "manufacturer_name": ["Xttrium Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE, PLASTIC (0116-4023-16)", "package_ndc": "0116-4023-16", "marketing_start_date": "20250407"}], "brand_name": "PROMETHAZINE HYDROCHLORIDE", "product_id": "0116-4023_302bfe23-7984-140e-e063-6394a90acad1", "dosage_form": "SYRUP", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "0116-4023", "generic_name": "promethazine hydrochloride", "labeler_name": "Xttrium Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PROMETHAZINE HYDROCHLORIDE", "active_ingredients": [{"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "6.25 mg/5mL"}], "application_number": "ANDA087953", "marketing_category": "ANDA", "marketing_start_date": "20250407", "listing_expiration_date": "20261231"}