Package 0121-1854-16
Brand: promethazine hydrochloride
Generic: promethazine hydrochloridePackage Facts
Identity
Package NDC
0121-1854-16
Digits Only
0121185416
Product NDC
0121-1854
Description
473 mL in 1 BOTTLE (0121-1854-16)
Marketing
Marketing Status
Brand
promethazine hydrochloride
Generic
promethazine hydrochloride
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "628c0c05-9610-4a8e-ae9b-f6aad47993d6", "openfda": {"unii": ["R61ZEH7I1I"], "rxcui": ["992432"], "spl_set_id": ["7a186bcd-ab8c-4695-8289-4cd33bb551cf"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (0121-1854-16)", "package_ndc": "0121-1854-16", "marketing_start_date": "20250807"}], "brand_name": "Promethazine Hydrochloride", "product_id": "0121-1854_628c0c05-9610-4a8e-ae9b-f6aad47993d6", "dosage_form": "SOLUTION", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "0121-1854", "generic_name": "Promethazine Hydrochloride", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Promethazine Hydrochloride", "active_ingredients": [{"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "6.25 mg/5mL"}], "application_number": "ANDA040643", "marketing_category": "ANDA", "marketing_start_date": "20250807", "listing_expiration_date": "20261231"}