promethazine hydrochloride

Generic: promethazine hydrochloride

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hydrochloride
Generic Name promethazine hydrochloride
Labeler a-s medication solutions
Dosage Form TABLET
Routes
ORAL
Active Ingredients

promethazine hydrochloride 25 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-4813
Product ID 50090-4813_4639fbda-1925-4364-a4b2-75605a688fcf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040596
Listing Expiration 2026-12-31
Marketing Start 2005-12-14

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500904813
Hyphenated Format 50090-4813

Supplemental Identifiers

RxCUI
992447
UNII
R61ZEH7I1I

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name promethazine hydrochloride (source: ndc)
Generic Name promethazine hydrochloride (source: ndc)
Application Number ANDA040596 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 12 TABLET in 1 BOTTLE (50090-4813-0)
  • 10 TABLET in 1 BOTTLE (50090-4813-1)
  • 60 TABLET in 1 BOTTLE (50090-4813-5)
  • 20 TABLET in 1 BOTTLE (50090-4813-6)
  • 30 TABLET in 1 BOTTLE (50090-4813-9)
source: ndc

Packages (5)

50090-4813-0 12 TABLET in 1 BOTTLE (50090-4813-0) 50090-4813-1 10 TABLET in 1 BOTTLE (50090-4813-1) 50090-4813-5 60 TABLET in 1 BOTTLE (50090-4813-5) 50090-4813-6 20 TABLET in 1 BOTTLE (50090-4813-6) 50090-4813-9 30 TABLET in 1 BOTTLE (50090-4813-9)

Ingredients (1)

promethazine hydrochloride (25 mg/1)

Linked Drug Pages (1)

Promethazine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4639fbda-1925-4364-a4b2-75605a688fcf", "openfda": {"unii": ["R61ZEH7I1I"], "rxcui": ["992447"], "spl_set_id": ["6aa6bfcc-024b-4ee2-a586-6c4ca879cea4"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "12 TABLET in 1 BOTTLE (50090-4813-0)", "package_ndc": "50090-4813-0", "marketing_start_date": "20191227"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE (50090-4813-1)", "package_ndc": "50090-4813-1", "marketing_start_date": "20191227"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (50090-4813-5)", "package_ndc": "50090-4813-5", "marketing_start_date": "20191227"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (50090-4813-6)", "package_ndc": "50090-4813-6", "marketing_start_date": "20191227"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (50090-4813-9)", "package_ndc": "50090-4813-9", "marketing_start_date": "20191227"}], "brand_name": "Promethazine Hydrochloride", "product_id": "50090-4813_4639fbda-1925-4364-a4b2-75605a688fcf", "dosage_form": "TABLET", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "50090-4813", "generic_name": "Promethazine Hydrochloride", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Promethazine Hydrochloride", "active_ingredients": [{"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA040596", "marketing_category": "ANDA", "marketing_start_date": "20051214", "listing_expiration_date": "20261231"}