promethazine hydrochloride

Generic: promethazine hydrochloride

Labeler: sportpharm, inc. dba sportpharm
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hydrochloride
Generic Name promethazine hydrochloride
Labeler sportpharm, inc. dba sportpharm
Dosage Form TABLET
Routes
ORAL
Active Ingredients

promethazine hydrochloride 25 mg/1

Manufacturer
Sportpharm, Inc. dba Sportpharm

Identifiers & Regulatory

Product NDC 85766-109
Product ID 85766-109_4156da33-938e-8e96-e063-6394a90a4dc9
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 85766109
Hyphenated Format 85766-109

Supplemental Identifiers

RxCUI
992438 992447 992475
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
  • 1000 TABLET in 1 BOTTLE (85766-109-00)
  • 100 TABLET in 1 BOTTLE (85766-109-01)
  • 500 TABLET in 1 BOTTLE (85766-109-05)
  • 10 TABLET in 1 BOTTLE (85766-109-10)
  • 20 TABLET in 1 BOTTLE (85766-109-20)
  • 30 TABLET in 1 BOTTLE (85766-109-30)
  • 60 TABLET in 1 BOTTLE (85766-109-60)
  • 90 TABLET in 1 BOTTLE (85766-109-90)
source: ndc

Packages (8)

85766-109-00 1000 TABLET in 1 BOTTLE (85766-109-00) 85766-109-01 100 TABLET in 1 BOTTLE (85766-109-01) 85766-109-05 500 TABLET in 1 BOTTLE (85766-109-05) 85766-109-10 10 TABLET in 1 BOTTLE (85766-109-10) 85766-109-20 20 TABLET in 1 BOTTLE (85766-109-20) 85766-109-30 30 TABLET in 1 BOTTLE (85766-109-30) 85766-109-60 60 TABLET in 1 BOTTLE (85766-109-60) 85766-109-90 90 TABLET in 1 BOTTLE (85766-109-90)

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": "4156da33-938e-8e96-e063-6394a90a4dc9", "openfda": {"unii": ["R61ZEH7I1I"], "rxcui": ["992438", "992447", "992475"], "spl_set_id": ["4156e780-7ecf-bcae-e063-6394a90a2ae2"], "manufacturer_name": ["Sportpharm, Inc. dba Sportpharm"]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (85766-109-00)", "package_ndc": "85766-109-00", "marketing_start_date": "20251017"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (85766-109-01)", "package_ndc": "85766-109-01", "marketing_start_date": "20251017"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (85766-109-05)", "package_ndc": "85766-109-05", "marketing_start_date": "20251017"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE (85766-109-10)", "package_ndc": "85766-109-10", "marketing_start_date": "20251017"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (85766-109-20)", "package_ndc": "85766-109-20", "marketing_start_date": "20251017"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (85766-109-30)", "package_ndc": "85766-109-30", "marketing_start_date": "20251017"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (85766-109-60)", "package_ndc": "85766-109-60", "marketing_start_date": "20251017"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (85766-109-90)", "package_ndc": "85766-109-90", "marketing_start_date": "20251017"}], "brand_name": "Promethazine Hydrochloride", "product_id": "85766-109_4156da33-938e-8e96-e063-6394a90a4dc9", "dosage_form": "TABLET", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "85766-109", "generic_name": "Promethazine Hydrochloride", "labeler_name": "Sportpharm, Inc. dba Sportpharm", "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"}