promethazine hydrochloride

Generic: promethazine hydrochloride

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hydrochloride
Generic Name promethazine hydrochloride
Labeler coupler llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

promethazine hydrochloride 50 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1447
Product ID 67046-1447_2d996626-a75c-950a-e063-6394a90a9c24
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040596
Listing Expiration 2026-12-31
Marketing Start 2025-02-07

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461447
Hyphenated Format 67046-1447

Supplemental Identifiers

RxCUI
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
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (67046-1447-3)
source: ndc

Packages (1)

67046-1447-3 30 TABLET in 1 BLISTER PACK (67046-1447-3)

Ingredients (1)

promethazine hydrochloride (50 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": "2d996626-a75c-950a-e063-6394a90a9c24", "openfda": {"unii": ["R61ZEH7I1I"], "rxcui": ["992475"], "spl_set_id": ["2d996287-9eed-265a-e063-6294a90a6969"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (67046-1447-3)", "package_ndc": "67046-1447-3", "marketing_start_date": "20250207"}], "brand_name": "Promethazine Hydrochloride", "product_id": "67046-1447_2d996626-a75c-950a-e063-6394a90a9c24", "dosage_form": "TABLET", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "67046-1447", "generic_name": "Promethazine Hydrochloride", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Promethazine Hydrochloride", "active_ingredients": [{"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA040596", "marketing_category": "ANDA", "marketing_start_date": "20250207", "listing_expiration_date": "20261231"}