promethazine hydrochloride

Generic: promethazine hydrochloride

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hydrochloride
Generic Name promethazine hydrochloride
Labeler padagis israel pharmaceuticals ltd
Dosage Form SUPPOSITORY
Routes
RECTAL
Active Ingredients

promethazine hydrochloride 12.5 mg/1

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-758
Product ID 45802-758_14ed3375-f9ec-40bf-8529-cafc44c46f28
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040500
Listing Expiration 2026-12-31
Marketing Start 2006-06-27

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45802758
Hyphenated Format 45802-758

Supplemental Identifiers

RxCUI
992441 992454
UNII
R61ZEH7I1I

Packaging Origin

Original Packager
true

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 ANDA040500 (source: ndc)
Routes
RECTAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 12 BLISTER PACK in 1 CARTON (45802-758-30) / 1 SUPPOSITORY in 1 BLISTER PACK (45802-758-00)
source: ndc

Packages (1)

45802-758-30 12 BLISTER PACK in 1 CARTON (45802-758-30) / 1 SUPPOSITORY in 1 BLISTER PACK (45802-758-00)

Ingredients (1)

promethazine hydrochloride (12.5 mg/1)

Linked Drug Pages (1)

Promethazine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RECTAL"], "spl_id": "14ed3375-f9ec-40bf-8529-cafc44c46f28", "openfda": {"unii": ["R61ZEH7I1I"], "rxcui": ["992441", "992454"], "spl_set_id": ["047b9a7c-586b-4635-a63e-2c7ce9ec34e7"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 BLISTER PACK in 1 CARTON (45802-758-30)  / 1 SUPPOSITORY in 1 BLISTER PACK (45802-758-00)", "package_ndc": "45802-758-30", "marketing_start_date": "20060627"}], "brand_name": "Promethazine Hydrochloride", "product_id": "45802-758_14ed3375-f9ec-40bf-8529-cafc44c46f28", "dosage_form": "SUPPOSITORY", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "45802-758", "generic_name": "Promethazine Hydrochloride", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Promethazine Hydrochloride", "active_ingredients": [{"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "12.5 mg/1"}], "application_number": "ANDA040500", "marketing_category": "ANDA", "marketing_start_date": "20060627", "listing_expiration_date": "20261231"}